Generalized Anxiety Disorder, Panic Disorder
Conditions
Brief summary
An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder. Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI alone during the study. Most symptom evaluations will be done using an automated phone interview system. There are 4 clinic visits.
Interventions
DRUGNiravam
DRUGSSRI/SNRI
Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be at least 18 years of age. * Diagnosed by the Investigator with primary Generalized Anxiety Disorder (GAD) and/or primary Panic Disorder with or without agoraphobia, either primary episode or recurrence, and is positive for GAD or Panic Disorder by the MHS (Mental Health Screener)). * Receiving a new prescription for all SSRI or SNRI as indicated for GAD or Panic Disorder with or without agoraphobia. Definition of a new prescription in case of a recurrence in symptoms is no prescription or refill of prescription of SSRI or SNRI for the past 6 months. * Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent.
Exclusion criteria
* Presence of medical condition or presence of schizophrenia, bipolar disorder, alcohol abuse/dependence or any other primary major psychiatric disorder that, in the opinion of the Investigator, would jeopardize the subject or compromise the subject's ability to participate in the trial. * Is a current suicide risk in the opinion of the Investigator. * Has initiated cognitive therapy within two months of Study Day 1. * Does not speak English or does not hear well enough to be able to perform the Hamilton Anxiety (HAM-A) Rating Scale and Mental Health Screener (MHS) by Interactive Voice Response System (IVRS). * Has taken a benzodiazepine within the past 30 days. * History of hypersensitivity or allergic response to any of the components of SSRIs, SNRIs, benzodiazepines, or related drugs. * If a female of child-bearing potential, is pregnant, nursing, or not using appropriate birth control methods. * Presence of contraindications to the SSRI or SNRI to be prescribed per the specific package insert. * Presence of acute narrow angle glaucoma or taking ketoconazole or itraconazole,which are contraindications to Niravam per the package insert. * History of phenylketonuria (PKU). * Participation in a previous clinical trial within 30 days prior to Study Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | 10 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented. |
| Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | 10 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total HAM-A Score After 3 Weeks | Baseline and 3 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. |
| Change From Baseline in the Total HAM-A Score After 4 Weeks | Baseline and 4 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. |
| Change From Baseline in the Total HAM-A Score After 5 Weeks | Baseline and 5 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. |
| Change From Baseline in the Total HAM-A Score After 6 Weeks | Baseline and 6 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. |
| Change From Baseline in the Total HAM-A Score After 7 Weeks | Baseline and 7 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. |
| Change From Baseline in the Total HAM-A Score After 8 Weeks | Baseline and 8 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. |
| Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period | Baseline and at endpoint during the 8 week treatment period | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period. |
| Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week | 1 week | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). |
| Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks | 2 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). |
| Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks | 3 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). |
| Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks | 4 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). |
| Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks | 5 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). |
| Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks | 6 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). |
| Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks | 7 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). |
| Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks | 8 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). |
| Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period | at endpoint during the 8 week treatment period | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Endpoint is last observed value during the 8 week treatment period. |
| Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Baseline and 2 weeks | The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). |
| Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Baseline and 4 weeks | The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). |
| Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Baseline and 8 weeks | The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). |
| Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Baseline and at endpoint during the 8 week treatment period | The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). Endpoint is last observed value during the 8 week treatment period. |
| Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | 1 week | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). |
| Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | 2 weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect. |
| Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | 3 weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). |
| Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | 4 weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). |
| Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | 5 weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). |
| Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | 6 weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). |
| Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | 7 weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). |
| Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | 8 weeks | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). |
| Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | at endpoint during the 8 week treatment period | The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). Endpoint is last observed value during the 8 week treatment period. |
| Change From Baseline in HAM-A-insomnia Subscore After 1 Week | Baseline and 1 week | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. |
| Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks | Baseline and 2 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. |
| Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks | Baseline and 3 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. |
| Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks | Baseline and 4 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. |
| Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks | Baseline and 5 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. |
| Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks | Baseline and 6 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. |
| Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks | Baseline and 7 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. |
| Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks | Baseline and 8 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. |
| Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period | Baseline and at endpoint during the 8 week treatment period | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period. |
| Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week | Baseline and 1 week | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. |
| Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks | Baseline and 2 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. |
| Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks | Baseline and 3 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. |
| Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks | Baseline and 4 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. |
| Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks | Baseline and 5 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. |
| Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks | Baseline and 6 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. |
| Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks | Baseline and 7 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. |
| Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks | Baseline and 8 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. |
| Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period | Baseline and at endpoint during the 8 week treatment period | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. Endpoint is last observed value during the 8 week treatment period. |
| Change From Baseline in HAM-A-somatic Subscore After 1 Week | Baseline and 1 week | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. |
| Change From Baseline in HAM-A-somatic Subscore After 2 Weeks | Baseline and 2 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. |
| Change From Baseline in HAM-A-somatic Subscore After 3 Weeks | Baseline and 3 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. |
| Change From Baseline in HAM-A-somatic Subscore After 4 Weeks | Baseline and 4 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. |
| Change From Baseline in HAM-A-somatic Subscore After 5 Weeks | Baseline and 5 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. |
| Change From Baseline in HAM-A-somatic Subscore After 6 Weeks | Baseline and 6 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. |
| Change From Baseline in HAM-A-somatic Subscore After 7 Weeks | Baseline and 7 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. |
| Change From Baseline in HAM-A-somatic Subscore After 8 Weeks | Baseline and 8 weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. |
| Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period | Baseline and at endpoint during the 8 week treatment period | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. Endpoint is last observed value during the 8 week treatment period. |
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week | 1 week | — |
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks | 2 weeks | — |
| Change From Baseline in the Total HAM-A Score After 1 Week | Baseline and 1 week | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. |
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks | 4 weeks | — |
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks | 5 weeks | — |
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks | 6 weeks | — |
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks | 7 weeks | — |
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks | 8 weeks | — |
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period | at endpoint during the 8 week treatment period | Endpoint is last observed value during the 8 week treatment period. |
| Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks | 3 weeks | — |
| Change From Baseline in the Total HAM-A Score After 2 Weeks | Baseline and 2 Weeks | The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. |
Countries
United States
Participant flow
Recruitment details
Participants Flow shows 418 subjects that have been enrolled and randomized. The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
Pre-assignment details
Baseline Characteristics are only available for the Intent-to-treat population (subjects who received one dose of SSRI/SNRI and/or Niravam and have an assessment beyond the Baseline assessment)
Participants by arm
| Arm | Count |
|---|---|
| Panic: Niravam+SSRI/SNRI Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI | 125 |
| Panic: SSRI/SNRI Alone Panic Disorder: Newly prescribed SSRI or SNRI alone | 120 |
| GAD : Niravam+SSRI/SNRI Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI | 67 |
| GAD: SSRI/SNRI Alone Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone | 62 |
| Total | 374 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 2 | 1 | 1 |
| Overall Study | Lack of Efficacy | 2 | 6 | 1 | 2 |
| Overall Study | Lost to Follow-up | 18 | 21 | 6 | 8 |
| Overall Study | Other | 7 | 4 | 2 | 0 |
| Overall Study | Protocol Violation | 5 | 3 | 4 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 10 | 3 | 9 |
Baseline characteristics
| Characteristic | Panic: SSRI/SNRI Alone | GAD : Niravam+SSRI/SNRI | Panic: Niravam+SSRI/SNRI | GAD: SSRI/SNRI Alone | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 5 Participants | 1 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants | 66 Participants | 120 Participants | 61 Participants | 366 Participants |
| Age, Continuous | 38.1 years STANDARD_DEVIATION 12.55 | 40.1 years STANDARD_DEVIATION 12.64 | 40.1 years STANDARD_DEVIATION 12.24 | 43.6 years STANDARD_DEVIATION 12.2 | 40 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 120 participants | 67 participants | 125 participants | 62 participants | 374 participants |
| Sex: Female, Male Female | 93 Participants | 50 Participants | 102 Participants | 42 Participants | 287 Participants |
| Sex: Female, Male Male | 27 Participants | 17 Participants | 23 Participants | 20 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 137 | 10 / 135 | 12 / 71 | 5 / 71 |
| serious Total, serious adverse events | 3 / 137 | 2 / 135 | 0 / 71 | 2 / 71 |
Outcome results
Primary
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Time frame: 10 weeks
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 2 | 3.20 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 6 | 71.57 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 3 | 45.83 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 5 | 69.68 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Weeks 9 to 10 | 83.30 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 7 | 74.59 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 4 | 59.22 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 8 | 76.62 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 1 | 1.60 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 8 | 76.27 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 5 | 65.99 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 6 | 69.79 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 7 | 74.11 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 2 | 21.73 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 1 | 0.83 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 3 | 39.43 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Weeks 9 to 10 | 82.20 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 4 | 52.40 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 3 | 51.22 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 8 | 76.47 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Weeks 9 to 10 | 83.82 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 6 | 69.66 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 2 | 32.93 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 7 | 74.66 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 1 | 1.49 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 4 | 57.32 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 5 | 66.47 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Weeks 9 to 10 | 76.11 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 6 | 71.94 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 7 | 73.94 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 1 | 1.61 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 2 | 27.52 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 3 | 48.89 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 4 | 62.14 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 5 | 65.92 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) | Week 8 | 73.94 cumulative percent of responders |
Comparison: This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.p-value: 0.1143Generalized Wilcoxon
Comparison: This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.p-value: 0.4544Generalized Wilcoxon
Primary
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Time frame: 10 weeks
Population: Per Protocol Population (subjects of ITT population who have no major protocol violations)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 7 | 79.83 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 6 | 77.59 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 9 to 10 | 86.60 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 4 | 63.18 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 3 | 51.23 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 2 | 35.58 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 8 | 80.95 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 5 | 75.45 cumulative percent of responders |
| Panic: Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 1 | 1.92 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 5 | 67.59 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 7 | 75.77 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 6 | 71.94 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 2 | 24.53 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 1 | 0.94 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 3 | 41.54 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 9 to 10 | 84.82 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 8 | 78.32 cumulative percent of responders |
| Panic: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 4 | 54.19 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 5 | 67.92 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 1 | 1.89 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 2 | 33.96 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 3 | 52.83 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 4 | 58.49 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 6 | 71.70 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 7 | 77.70 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 8 | 79.93 cumulative percent of responders |
| GAD : Niravam+SSRI/SNRI | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 9 to 10 | 86.62 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 7 | 79.56 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 4 | 67.21 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 3 | 53.16 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 9 to 10 | 82.48 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 8 | 79.56 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 2 | 30.78 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 6 | 79.56 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 5 | 71.89 cumulative percent of responders |
| GAD: SSRI/SNRI Alone | Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) | Week 1 | 2.04 cumulative percent of responders |
Comparison: This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.p-value: 0.044Generalized Wilcoxon Test
Comparison: This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.p-value: 0.6587Generalized Wilcoxon Test
Secondary
Change From Baseline in HAM-A-insomnia Subscore After 1 Week
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time frame: Baseline and 1 week
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 1 Week | -0.9 Units on a scale | Standard Deviation 1.42 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 1 Week | -0.6 Units on a scale | Standard Deviation 1.43 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 1 Week | -1.0 Units on a scale | Standard Deviation 1.4 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 1 Week | -0.5 Units on a scale | Standard Deviation 1.4 |
p-value: 0.0677ANCOVA
p-value: 0.0273ANCOVA
Secondary
Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time frame: Baseline and 2 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks | -1.0 Units on a scale | Standard Deviation 1.49 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks | -0.9 Units on a scale | Standard Deviation 1.4 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks | -1.2 Units on a scale | Standard Deviation 1.5 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks | -0.6 Units on a scale | Standard Deviation 1.5 |
p-value: 0.5153ANCOVA
p-value: 0.0122ANCOVA
Secondary
Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time frame: Baseline and 3 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks | -1.2 Units on a scale | Standard Deviation 1.48 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks | -1.1 Units on a scale | Standard Deviation 1.43 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks | -1.4 Units on a scale | Standard Deviation 1.4 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks | -1.2 Units on a scale | Standard Deviation 1.36 |
p-value: 0.4648ANCOVA
p-value: 0.5502ANCOVA
Secondary
Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time frame: Baseline and 4 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks | -1.3 Units on a scale | Standard Deviation 1.65 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks | -1.4 Units on a scale | Standard Deviation 1.47 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks | -1.6 Units on a scale | Standard Deviation 1.34 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks | -1.1 Units on a scale | Standard Deviation 1.42 |
p-value: 0.9093ANCOVA
p-value: 0.1354ANCOVA
Secondary
Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time frame: Baseline and 5 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks | -1.3 Units on a scale | Standard Deviation 1.56 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks | -1.4 Units on a scale | Standard Deviation 1.52 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks | -1.5 Units on a scale | Standard Deviation 1.36 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks | -1.1 Units on a scale | Standard Deviation 1.22 |
p-value: 0.7434ANCOVA
p-value: 0.1148ANCOVA
Secondary
Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time frame: Baseline and 6 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks | -1.4 Units on a scale | Standard Deviation 1.64 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks | -1.5 Units on a scale | Standard Deviation 1.52 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks | -1.6 Units on a scale | Standard Deviation 1.25 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks | -1.1 Units on a scale | Standard Deviation 1.39 |
p-value: 0.9346ANCOVA
p-value: 0.2709ANCOVA
Secondary
Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time frame: Baseline and 7 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks | -1.5 Units on a scale | Standard Deviation 1.63 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks | -1.4 Units on a scale | Standard Deviation 1.49 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks | -1.6 Units on a scale | Standard Deviation 1.32 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks | -1.2 Units on a scale | Standard Deviation 1.4 |
p-value: 0.3827ANCOVA
p-value: 0.2513ANCOVA
Secondary
Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Time frame: Baseline and 8 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks | -1.6 Units on a scale | Standard Deviation 1.57 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks | -1.6 Units on a scale | Standard Deviation 1.41 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks | -1.6 Units on a scale | Standard Deviation 1.33 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks | -1.3 Units on a scale | Standard Deviation 1.41 |
p-value: 0.393ANCOVA
p-value: 0.5461ANCOVA
Secondary
Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Time frame: Baseline and at endpoint during the 8 week treatment period
Population: ITT population, Last Observation Carried Forward imputation was applied
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period | -1.6 Units on a scale | Standard Deviation 1.53 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period | -1.4 Units on a scale | Standard Deviation 1.49 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period | -1.5 Units on a scale | Standard Deviation 1.38 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period | -1.3 Units on a scale | Standard Deviation 1.51 |
p-value: 0.0722ANCOVA
p-value: 0.4639ANCOVA
Secondary
Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time frame: Baseline and 1 week
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week | -4.9 Units on a scale | Standard Deviation 5.73 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week | -2.9 Units on a scale | Standard Deviation 4.78 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week | -4.5 Units on a scale | Standard Deviation 4.53 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week | -3.3 Units on a scale | Standard Deviation 4.08 |
p-value: 0.0075ANCOVA
p-value: 0.1641ANCOVA
Secondary
Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time frame: Baseline and 2 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks | -6.0 Units on a scale | Standard Deviation 5.97 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks | -4.5 Units on a scale | Standard Deviation 4.88 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks | -5.8 Units on a scale | Standard Deviation 5.23 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks | -4.1 Units on a scale | Standard Deviation 4.53 |
p-value: 0.0932ANCOVA
p-value: 0.0852ANCOVA
Secondary
Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time frame: Baseline and 3 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks | -7.3 Units on a scale | Standard Deviation 5.98 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks | -6.8 Units on a scale | Standard Deviation 5.42 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks | -6.4 Units on a scale | Standard Deviation 5.44 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks | -6.1 Units on a scale | Standard Deviation 4.87 |
p-value: 0.7896ANCOVA
p-value: 0.9651ANCOVA
Secondary
Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time frame: Baseline and 4 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks | -7.7 Units on a scale | Standard Deviation 5.95 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks | -7.4 Units on a scale | Standard Deviation 5.57 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks | -7.8 Units on a scale | Standard Deviation 5.14 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks | -5.9 Units on a scale | Standard Deviation 4.8 |
p-value: 0.828ANCOVA
p-value: 0.0936ANCOVA
Secondary
Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time frame: Baseline and 5 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks | -8.7 Units on a scale | Standard Deviation 5.84 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks | -7.7 Units on a scale | Standard Deviation 5.99 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks | -7.9 Units on a scale | Standard Deviation 5.08 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks | -6.8 Units on a scale | Standard Deviation 5.76 |
p-value: 0.3539ANCOVA
p-value: 0.4672ANCOVA
Secondary
Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time frame: Baseline and 6 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks | -9.4 Units on a scale | Standard Deviation 5.84 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks | -8.3 Units on a scale | Standard Deviation 5.66 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks | -8.7 Units on a scale | Standard Deviation 4.81 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks | -7.2 Units on a scale | Standard Deviation 5.82 |
p-value: 0.255ANCOVA
p-value: 0.3125ANCOVA
Secondary
Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time frame: Baseline and 7 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks | -9.6 Units on a scale | Standard Deviation 6.27 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks | -8.4 Units on a scale | Standard Deviation 5.75 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks | -8.1 Units on a scale | Standard Deviation 5.16 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks | -7.6 Units on a scale | Standard Deviation 6.19 |
p-value: 0.3174ANCOVA
p-value: 0.9427ANCOVA
Secondary
Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Time frame: Baseline and 8 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks | -9.9 Units on a scale | Standard Deviation 6.63 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks | -8.9 Units on a scale | Standard Deviation 5.13 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks | -8.5 Units on a scale | Standard Deviation 4.91 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks | -8.5 Units on a scale | Standard Deviation 5.51 |
p-value: 0.3252ANCOVA
p-value: 0.609ANCOVA
Secondary
Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Time frame: Baseline and at endpoint during the 8 week treatment period
Population: ITT population, Last Observation Carried Forward imputation was applied
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period | -9.1 Units on a scale | Standard Deviation 6.58 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period | -7.6 Units on a scale | Standard Deviation 5.82 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period | -7.9 Units on a scale | Standard Deviation 5.19 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period | -7.9 Units on a scale | Standard Deviation 5.81 |
p-value: 0.1247ANCOVA
p-value: 0.843ANCOVA
Secondary
Change From Baseline in HAM-A-somatic Subscore After 1 Week
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time frame: Baseline and 1 week
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 1 Week | -4.4 Units on a scale | Standard Deviation 6.95 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 1 Week | -2.9 Units on a scale | Standard Deviation 5.8 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 1 Week | -3.3 Units on a scale | Standard Deviation 4.46 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 1 Week | -1.4 Units on a scale | Standard Deviation 5.43 |
p-value: 0.1031ANCOVA
p-value: 0.0543ANCOVA
Secondary
Change From Baseline in HAM-A-somatic Subscore After 2 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time frame: Baseline and 2 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 2 Weeks | -5.6 Units on a scale | Standard Deviation 6.31 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 2 Weeks | -3.7 Units on a scale | Standard Deviation 6.18 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 2 Weeks | -4.2 Units on a scale | Standard Deviation 5.52 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 2 Weeks | -2.0 Units on a scale | Standard Deviation 6.05 |
p-value: 0.0508ANCOVA
p-value: 0.0871ANCOVA
Secondary
Change From Baseline in HAM-A-somatic Subscore After 3 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time frame: Baseline and 3 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 3 Weeks | -7.0 Units on a scale | Standard Deviation 7.03 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 3 Weeks | -6.1 Units on a scale | Standard Deviation 7.55 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 3 Weeks | -4.5 Units on a scale | Standard Deviation 5.85 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 3 Weeks | -3.4 Units on a scale | Standard Deviation 6.27 |
p-value: 0.8318ANCOVA
p-value: 0.5375ANCOVA
Secondary
Change From Baseline in HAM-A-somatic Subscore After 4 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time frame: Baseline and 4 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 4 Weeks | -7.5 Units on a scale | Standard Deviation 6.96 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 4 Weeks | -6.4 Units on a scale | Standard Deviation 6.5 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 4 Weeks | -5.1 Units on a scale | Standard Deviation 5.95 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 4 Weeks | -2.3 Units on a scale | Standard Deviation 5.71 |
p-value: 0.2186ANCOVA
p-value: 0.0422ANCOVA
Secondary
Change From Baseline in HAM-A-somatic Subscore After 5 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time frame: Baseline and 5 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 5 Weeks | -8.0 Units on a scale | Standard Deviation 7.21 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 5 Weeks | -6.8 Units on a scale | Standard Deviation 7.14 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 5 Weeks | -5.4 Units on a scale | Standard Deviation 5.31 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 5 Weeks | -3.4 Units on a scale | Standard Deviation 6.95 |
p-value: 0.1164ANCOVA
p-value: 0.1935ANCOVA
Secondary
Change From Baseline in HAM-A-somatic Subscore After 6 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time frame: Baseline and 6 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 6 Weeks | -8.3 Units on a scale | Standard Deviation 7.41 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 6 Weeks | -6.8 Units on a scale | Standard Deviation 7.32 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 6 Weeks | -4.7 Units on a scale | Standard Deviation 4.83 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 6 Weeks | -3.8 Units on a scale | Standard Deviation 6.19 |
p-value: 0.1244ANCOVA
p-value: 0.6182ANCOVA
Secondary
Change From Baseline in HAM-A-somatic Subscore After 7 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time frame: Baseline and 7 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 7 Weeks | -8.1 Units on a scale | Standard Deviation 7.74 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 7 Weeks | 7.2 Units on a scale | Standard Deviation 7.38 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 7 Weeks | -5.2 Units on a scale | Standard Deviation 5.37 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 7 Weeks | -3.7 Units on a scale | Standard Deviation 6.64 |
p-value: 0.4589ANCOVA
p-value: 0.393ANCOVA
Secondary
Change From Baseline in HAM-A-somatic Subscore After 8 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Time frame: Baseline and 8 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 8 Weeks | -8.6 Units on a scale | Standard Deviation 7.98 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 8 Weeks | -7.7 Units on a scale | Standard Deviation 7.43 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore After 8 Weeks | -5.5 Units on a scale | Standard Deviation 5.53 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore After 8 Weeks | -3.8 Units on a scale | Standard Deviation 5.76 |
p-value: 0.445ANCOVA
p-value: 0.2924ANCOVA
Secondary
Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Time frame: Baseline and at endpoint during the 8 week treatment period
Population: ITT population, Last Observation Carried Forward imputation was applied
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period | -8.2 Units on a scale | Standard Deviation 7.86 |
| Panic: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period | -6.7 Units on a scale | Standard Deviation 7.18 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period | -5.6 Units on a scale | Standard Deviation 5.72 |
| GAD: SSRI/SNRI Alone | Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period | -3.6 Units on a scale | Standard Deviation 6.24 |
p-value: 0.2184ANCOVA
p-value: 0.1281ANCOVA
Secondary
Change From Baseline in the Total HAM-A Score After 1 Week
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time frame: Baseline and 1 week
Population: ITT population, but only subjects with values at baseline and time point are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 1 Week | -9.3 Units on a scale | Standard Deviation 11.5 |
| Panic: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 1 Week | -5.8 Units on a scale | Standard Deviation 9.04 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 1 Week | -7.8 Units on a scale | Standard Deviation 7.43 |
| GAD: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 1 Week | -4.6 Units on a scale | Standard Deviation 8.33 |
Comparison: ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariatep-value: 0.0173ANCOVA
Comparison: ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariatep-value: 0.0516ANCOVA
Secondary
Change From Baseline in the Total HAM-A Score After 2 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time frame: Baseline and 2 Weeks
Population: ITT Population, only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 2 Weeks | -11.6 Units on a scale | Standard Deviation 10.98 |
| Panic: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 2 Weeks | -8.2 Units on a scale | Standard Deviation 9.37 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 2 Weeks | -10.0 Units on a scale | Standard Deviation 8.75 |
| GAD: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 2 Weeks | -6.1 Units on a scale | Standard Deviation 9.06 |
p-value: 0.0361ANCOVA
p-value: 0.0366ANCOVA
Secondary
Change From Baseline in the Total HAM-A Score After 3 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time frame: Baseline and 3 weeks
Population: ITT population, only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 3 Weeks | -14.3 Units on a scale | Standard Deviation 11.81 |
| Panic: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 3 Weeks | -12.9 Units on a scale | Standard Deviation 11.03 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 3 Weeks | -10.9 Units on a scale | Standard Deviation 9.7 |
| GAD: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 3 Weeks | -9.5 Units on a scale | Standard Deviation 9.49 |
p-value: 0.739ANCOVA
p-value: 0.6735ANCOVA
Secondary
Change From Baseline in the Total HAM-A Score After 4 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time frame: Baseline and 4 weeks
Population: ITT population, only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 4 Weeks | -15.2 Units on a scale | Standard Deviation 11.66 |
| Panic: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 4 Weeks | -13.7 Units on a scale | Standard Deviation 10.58 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 4 Weeks | -12.9 Units on a scale | Standard Deviation 9.47 |
| GAD: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 4 Weeks | -8.3 Units on a scale | Standard Deviation 8.35 |
p-value: 0.4261ANCOVA
p-value: 0.0231ANCOVA
Secondary
Change From Baseline in the Total HAM-A Score After 5 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time frame: Baseline and 5 weeks
Population: ITT population, only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 5 Weeks | -16.7 Units on a scale | Standard Deviation 11.81 |
| Panic: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 5 Weeks | -14.4 Units on a scale | Standard Deviation 11.69 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 5 Weeks | -13.3 Units on a scale | Standard Deviation 8.41 |
| GAD: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 5 Weeks | -10.3 Units on a scale | Standard Deviation 10.99 |
p-value: 0.182ANCOVA
p-value: 0.2187ANCOVA
Secondary
Change From Baseline in the Total HAM-A Score After 6 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time frame: Baseline and 6 weeks
Population: ITT population, only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 6 Weeks | -17.7 Units on a scale | Standard Deviation 11.94 |
| Panic: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 6 Weeks | -15.1 Units on a scale | Standard Deviation 11.59 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 6 Weeks | -13.4 Units on a scale | Standard Deviation 8 |
| GAD: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 6 Weeks | -11.0 Units on a scale | Standard Deviation 10.44 |
p-value: 0.1456ANCOVA
p-value: 0.3618ANCOVA
Secondary
Change From Baseline in the Total HAM-A Score After 7 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time frame: Baseline and 7 weeks
Population: ITT population, only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 7 Weeks | -17.7 Units on a scale | Standard Deviation 12.75 |
| Panic: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 7 Weeks | -15.6 Units on a scale | Standard Deviation 11.78 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 7 Weeks | -13.3 Units on a scale | Standard Deviation 8.85 |
| GAD: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 7 Weeks | -11.3 Units on a scale | Standard Deviation 11.32 |
p-value: 0.3535ANCOVA
p-value: 0.566ANCOVA
Secondary
Change From Baseline in the Total HAM-A Score After 8 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Time frame: Baseline and 8 weeks
Population: ITT population, only subjects with non-missing values have been included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 8 Weeks | -18.5 Units on a scale | Standard Deviation 13.38 |
| Panic: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 8 Weeks | -16.6 Units on a scale | Standard Deviation 10.72 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score After 8 Weeks | -13.9 Units on a scale | Standard Deviation 8.71 |
| GAD: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score After 8 Weeks | -12.3 Units on a scale | Standard Deviation 9.49 |
p-value: 0.3414ANCOVA
p-value: 0.7344ANCOVA
Secondary
Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period.
Time frame: Baseline and at endpoint during the 8 week treatment period
Population: ITT population, Last Observation Carried Forward imputation was applied
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period | -17.3 Units on a scale | Standard Deviation 13.03 |
| Panic: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period | -14.3 Units on a scale | Standard Deviation 11.32 |
| GAD : Niravam+SSRI/SNRI | Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period | -13.6 Units on a scale | Standard Deviation 8.85 |
| GAD: SSRI/SNRI Alone | Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period | -11.5 Units on a scale | Standard Deviation 10.44 |
p-value: 0.1197ANCOVA
p-value: 0.4416ANCOVA
Secondary
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Time frame: Baseline and 2 weeks
Population: ITT population, but only patients with non-missing values were included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | much improved | 38 Participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Very much worse | 0 Participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Much worse | 1 Participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | minimally improved | 53 Participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Very much improved | 6 Participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | No change | 17 Participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Minimally worse | 4 Participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Very much worse | 0 Participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Minimally worse | 7 Participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | No change | 40 Participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Much worse | 1 Participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Very much improved | 1 Participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | minimally improved | 35 Participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | much improved | 23 Participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Minimally worse | 1 Participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | much improved | 25 Participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | minimally improved | 27 Participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | No change | 9 Participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Much worse | 0 Participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Very much worse | 0 Participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Very much improved | 4 Participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | No change | 18 Participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Very much improved | 2 Participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Very much worse | 0 Participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | minimally improved | 20 Participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | much improved | 10 Participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Much worse | 1 Participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks | Minimally worse | 6 Participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0002van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0006van Elteren test
Secondary
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Time frame: Baseline and 4 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Very much improved | 18 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Much worse | 1 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Minimally worse | 6 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Much improved | 40 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Very much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Minimally improved | 35 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | No change | 7 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Much worse | 2 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | No change | 19 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Minimally improved | 23 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Minimally worse | 9 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Very much worse | 1 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Much improved | 40 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Very much improved | 5 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | No change | 7 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Very much improved | 12 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Much improved | 26 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Minimally improved | 13 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Minimally worse | 1 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Much worse | 0 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Very much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Minimally improved | 17 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Much improved | 18 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Very much improved | 1 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | Minimally worse | 1 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks | No change | 9 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint, CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0255van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0065van Elteren test
Secondary
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Time frame: Baseline and 8 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Very much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Minimally improved | 16 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Much improved | 44 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Very much improved | 28 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Minimally worse | 2 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | No change | 3 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Very much improved | 27 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Very much worse | 1 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Minimally worse | 1 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Much improved | 27 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | No change | 19 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Minimally improved | 19 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Much worse | 2 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Very much worse | 0 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Very much improved | 14 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Much improved | 25 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Minimally improved | 11 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | No change | 5 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Minimally worse | 1 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | No change | 4 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Minimally improved | 13 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Much improved | 22 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Very much improved | 12 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks | Minimally worse | 0 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.037van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.9569van Elteren test
Secondary
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). Endpoint is last observed value during the 8 week treatment period.
Time frame: Baseline and at endpoint during the 8 week treatment period
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Very much improved | 31 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Much worse | 1 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Minimally worse | 6 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Much improved | 47 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Very much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Minimally improved | 30 participants |
| Panic: Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | No change | 7 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Much worse | 3 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | No change | 25 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Minimally improved | 24 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Minimally worse | 2 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Very much worse | 1 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Much improved | 31 participants |
| Panic: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Very much improved | 27 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | No change | 8 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Very much improved | 14 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Much improved | 29 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Minimally improved | 12 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Minimally worse | 2 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Much worse | 1 participants |
| GAD : Niravam+SSRI/SNRI | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Minimally improved | 16 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Much improved | 23 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Very much improved | 12 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | Minimally worse | 2 participants |
| GAD: SSRI/SNRI Alone | Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period | No change | 5 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0978van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.7096van Elteren test
Secondary
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time frame: 1 week
Population: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week | Response | 39 participants |
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week | No Response | 73 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week | No Response | 85 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week | Response | 24 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week | Response | 22 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week | No Response | 41 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week | Response | 16 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week | No Response | 41 participants |
Comparison: Analysis refers to test of differences in response rates.p-value: 0.035Chi-squared
Comparison: Analysis refers to test of differences in response rates.p-value: 0.4205Chi-squared
Secondary
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time frame: 2 weeks
Population: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks | Response | 48 participants |
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks | No Response | 60 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks | No Response | 65 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks | Response | 38 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks | Response | 30 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks | No Response | 31 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks | Response | 23 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks | No Response | 30 participants |
Comparison: Analysis refers to test of differences in response rates.p-value: 0.2645Chi-squared
Comparison: Analysis refers to test of differences in response rates.p-value: 0.5369Chi-squared
Secondary
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time frame: 3 weeks
Population: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks | Response | 56 participants |
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks | No Response | 45 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks | No Response | 41 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks | Response | 51 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks | Response | 33 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks | No Response | 25 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks | Response | 31 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks | No Response | 21 participants |
Comparison: Analysis refers to test of differences in response rates.p-value: 0.9988Chi-squared
Comparison: Analysis refers to test of differences in response rates.p-value: 0.7729Chi-squared
Secondary
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time frame: 4 weeks
Population: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks | Response | 58 participants |
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks | No Response | 39 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks | No Response | 34 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks | Response | 56 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks | Response | 37 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks | No Response | 17 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks | Response | 25 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks | No Response | 23 participants |
Comparison: Analysis refers to test of differences in response rates.p-value: 0.7338Chi-squared
Comparison: Analysis refers to test of differences in response rates.p-value: 0.0897Chi-squared
Secondary
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time frame: 5 weeks
Population: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks | Response | 59 participants |
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks | Non Response | 30 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks | Non Response | 30 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks | Response | 51 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks | Response | 33 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks | Non Response | 18 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks | Response | 30 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks | Non Response | 18 participants |
Comparison: Analysis refers to test of differences in response rates.p-value: 0.6501Chi-squared
Comparison: Analysis refers to test of differences in response rates.p-value: 0.8196Chi-squared
Secondary
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time frame: 6 weeks
Population: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks | Response | 63 participants |
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks | No Response | 24 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks | No Response | 25 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks | Response | 56 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks | Response | 31 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks | No Response | 16 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks | Response | 32 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks | No Response | 15 participants |
Comparison: Analysis refers to test of differences in response rates.p-value: 0.6404Chi-squared
Comparison: Analysis refers to test of differences in response rates.p-value: 0.8263Chi-squared
Secondary
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time frame: 7 weeks
Population: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks | No Response | 23 participants |
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks | Response | 60 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks | No Response | 25 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks | Response | 57 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks | Response | 37 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks | No Response | 16 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks | Response | 34 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks | No Response | 15 participants |
Comparison: Analysis refers to test of differences in response rates.p-value: 0.6946Chi-squared
Comparison: Analysis refers to test of differences in response rates.p-value: 0.9629Chi-squared
Secondary
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Time frame: 8 weeks
Population: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks | Response | 61 participants |
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks | No Response | 23 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks | No Response | 22 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks | Response | 62 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks | Response | 38 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks | No Response | 15 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks | Response | 35 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks | No Response | 12 participants |
Comparison: Analysis refers to test of differences in response rates.p-value: 0.8617Chi-squared
Comparison: Analysis refers to test of differences in response rates.p-value: 0.7555Chi-squared
Secondary
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Endpoint is last observed value during the 8 week treatment period.
Time frame: at endpoint during the 8 week treatment period
Population: ITT population, Last Observation Carried Forward imputation was applied
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period | Response | 78 participants |
| Panic: Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period | No Response | 39 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period | No Response | 43 participants |
| Panic: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period | Response | 74 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period | Response | 44 participants |
| GAD : Niravam+SSRI/SNRI | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period | No Response | 20 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period | Response | 40 participants |
| GAD: SSRI/SNRI Alone | Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period | No Response | 19 participants |
Comparison: Analysis refers to test of differences in response rates.p-value: 0.5836Chi-squared
Comparison: Analysis refers to test of differences in response rates.p-value: 0.9096Chi-squared
Secondary
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week
Time frame: 1 week
Population: ITT population, but only patients with non-missing assessments were included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week | Any panic attack | 76 participants |
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week | No panic attack | 42 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week | Any panic attack | 69 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week | No panic attack | 43 participants |
Comparison: test of difference in percentage of subjects reporting any panic attackp-value: 0.6602Chi-squared
Secondary
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks
Time frame: 2 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks | Any panic attack | 60 participants |
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks | No panic attack | 54 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks | Any panic attack | 60 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks | No panic attack | 46 participants |
Comparison: test of difference in percentage of subjects reporting any panic attackp-value: 0.5544Chi-squared
Secondary
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks
Time frame: 3 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks | Any panic attack | 41 participants |
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks | No panic attack | 66 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks | Any panic attack | 37 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks | No panic attack | 58 participants |
Comparison: test of difference in percentage of subjects reporting any panic attackp-value: 0.9269Chi-squared
Secondary
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks
Time frame: 4 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks | Any panic attack | 43 participants |
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks | No panic attack | 60 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks | Any panic attack | 43 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks | No panic attack | 50 participants |
Comparison: test of difference in percentage of subjects reporting any panic attackp-value: 0.5271Chi-squared
Secondary
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks
Time frame: 5 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks | Any panic attack | 35 participants |
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks | No panic attack | 60 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks | Any panic attack | 40 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks | No panic attack | 44 participants |
Comparison: test of difference in percentage of subjects reporting any panic attackp-value: 0.1447Chi-squared
Secondary
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks
Time frame: 6 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks | Any panic attack | 36 participants |
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks | No panic attack | 57 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks | Any panic attack | 33 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks | No panic attack | 51 participants |
p-value: 0.9375Chi-squared
Secondary
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks
Time frame: 7 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks | Any panic attack | 32 participants |
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks | No panic attack | 56 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks | Any panic attack | 31 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks | No panic attack | 54 participants |
Comparison: test of difference in percentage of subjects reporting any panic attackp-value: 0.9883Chi-squared
Secondary
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks
Time frame: 8 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks | Any panic attack | 26 participants |
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks | No panic attack | 62 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks | Any panic attack | 32 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks | No panic attack | 55 participants |
Comparison: test of difference in percentage of subjects reporting any panic attackp-value: 0.3093Chi-squared
Secondary
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period
Endpoint is last observed value during the 8 week treatment period.
Time frame: at endpoint during the 8 week treatment period
Population: ITT population, Last Observation Carried Forward imputation was applied
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period | Any panic attack | 47 participants |
| Panic: Niravam+SSRI/SNRI | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period | No panic attack | 76 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period | Any panic attack | 50 participants |
| Panic: SSRI/SNRI Alone | Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period | No panic attack | 70 participants |
Comparison: test of difference in percentage of subjects reporting any panic attackp-value: 0.5824Chi-squared
Secondary
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time frame: 1 week
Population: ITT population, but only patients with non-missing values are included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Very much better | 7 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Much worse | 1 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | A little worse | 2 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Much better | 24 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Very much worse | 1 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | A little better | 35 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Unchanged | 39 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Much worse | 5 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Unchanged | 46 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | A little better | 40 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | A little worse | 6 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Very much worse | 0 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Much better | 5 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Very much better | 0 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Unchanged | 20 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Very much better | 3 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Much better | 10 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | A little better | 27 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | A little worse | 1 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Much worse | 0 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | A little better | 9 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Very much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Much worse | 2 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Much better | 7 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Very much better | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | A little worse | 3 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week | Unchanged | 31 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0001van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0003van Elteren test
Secondary
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.
Time frame: 2 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Very much better | 10 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Much worse | 4 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | A little worse | 3 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Much better | 30 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Very much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | A little better | 34 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Unchanged | 29 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Much worse | 5 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Unchanged | 37 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | A little better | 38 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | A little worse | 3 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Very much worse | 3 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Much better | 16 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Very much better | 2 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Unchanged | 13 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Very much better | 5 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Much better | 21 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | A little better | 21 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | A little worse | 0 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Much worse | 1 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Very much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | A little better | 20 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Very much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Much worse | 2 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Much better | 7 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Very much better | 4 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | A little worse | 3 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks | Unchanged | 17 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0025van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0101van Elteren test
Secondary
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time frame: 3 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Very much better | 22 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Much worse | 1 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | A little worse | 2 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Much better | 23 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Very much worse | 2 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | A little better | 33 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Unchanged | 24 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Much worse | 5 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Unchanged | 31 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | A little better | 28 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | A little worse | 3 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Very much worse | 0 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Much better | 21 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Very much better | 7 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Unchanged | 12 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Very much better | 10 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Much better | 21 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | A little better | 16 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | A little worse | 1 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Much worse | 1 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | A little better | 22 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Very much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Much better | 14 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Very much better | 2 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | A little worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks | Unchanged | 13 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0095van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.039van Elteren test
Secondary
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time frame: 4 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Very much better | 18 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Much worse | 2 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | A little worse | 2 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Much better | 38 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Very much worse | 2 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | A little better | 26 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Unchanged | 14 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Much worse | 3 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Unchanged | 28 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | A little better | 20 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | A little worse | 4 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Very much worse | 1 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Much better | 24 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Very much better | 13 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Unchanged | 5 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Very much better | 13 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Much better | 19 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | A little better | 16 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | A little worse | 2 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Much worse | 2 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | A little better | 18 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Very much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Much better | 14 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Very much better | 6 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | A little worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks | Unchanged | 8 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.016van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.1024van Elteren test
Secondary
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time frame: 5 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Very much better | 21 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Much worse | 6 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | A little worse | 3 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Much better | 32 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Very much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | A little better | 16 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Unchanged | 16 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Much worse | 6 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Unchanged | 19 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | A little better | 19 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | A little worse | 2 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Very much worse | 1 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Much better | 27 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Very much better | 10 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Unchanged | 4 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Very much better | 13 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Much better | 19 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | A little better | 18 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | A little worse | 0 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Much worse | 0 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | A little better | 10 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Very much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Much better | 20 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Very much better | 5 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | A little worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks | Unchanged | 12 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0761van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0376van Elteren test
Secondary
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time frame: 6 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Very much better | 22 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Much worse | 1 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | A little worse | 2 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Much better | 29 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Very much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | A little better | 23 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Unchanged | 16 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Much worse | 5 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Unchanged | 18 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | A little better | 17 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | A little worse | 2 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Very much worse | 2 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Much better | 24 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Very much better | 16 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Unchanged | 4 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Very much better | 15 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Much better | 20 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | A little better | 11 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | A little worse | 0 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Much worse | 0 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | A little better | 16 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Very much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Much better | 15 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Very much better | 6 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | A little worse | 2 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks | Unchanged | 8 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.1196van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint.CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0029van Elteren test
Secondary
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time frame: 7 weeks
Population: ITT population, but only subjects with non-missing values have been included
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Very much better | 23 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Much worse | 2 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | A little worse | 3 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Much better | 28 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Very much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | A little better | 17 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Unchanged | 15 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Much worse | 1 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Unchanged | 18 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | A little better | 17 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | A little worse | 1 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Very much worse | 2 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Very much better | 21 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Much better | 24 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Much better | 23 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Very much better | 12 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | A little better | 11 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Unchanged | 8 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | A little worse | 2 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Much worse | 0 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | A little better | 7 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Very much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Much better | 23 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Very much better | 8 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | A little worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks | Unchanged | 9 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.6323van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.5533van Elteren test
Secondary
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Time frame: 8 weeks
Population: ITT population, Last Observation Carried Forward imputation was applied
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | A little worse | 2 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Very much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | A little better | 17 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Much better | 28 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Very much better | 28 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Unchanged | 13 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Very much better | 23 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | A little worse | 0 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Very much worse | 1 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Much better | 22 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Unchanged | 16 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | A little better | 21 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Much worse | 3 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Unchanged | 8 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Very much better | 20 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Much better | 14 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | A little better | 13 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | A little worse | 1 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Much worse | 0 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | A little better | 12 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Very much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Much worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Much better | 13 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Very much better | 13 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | A little worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks | Unchanged | 7 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.1705van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.3196van Elteren test
Secondary
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). Endpoint is last observed value during the 8 week treatment period.
Time frame: at endpoint during the 8 week treatment period
Population: ITT population, Last Observation Carried Forward imputation was applied
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Very much better | 34 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Much worse | 3 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | A little worse | 3 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Much better | 36 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Very much worse | 0 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | A little better | 27 participants |
| Panic: Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Unchanged | 20 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Much worse | 6 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Unchanged | 30 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | A little better | 30 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | A little worse | 0 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Very much worse | 1 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Much better | 27 participants |
| Panic: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Very much better | 25 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Unchanged | 12 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Very much better | 21 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Much better | 14 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | A little better | 17 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | A little worse | 1 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Much worse | 1 participants |
| GAD : Niravam+SSRI/SNRI | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Very much worse | 0 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | A little better | 14 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Very much worse | 2 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Much worse | 3 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Much better | 15 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Very much better | 14 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | A little worse | 1 participants |
| GAD: SSRI/SNRI Alone | Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period | Unchanged | 11 participants |
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.0419van Elteren test
Comparison: van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.p-value: 0.2541van Elteren test