Generalized Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder, GAD
Brief summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD)
Interventions
DRUGPlacebo
Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,
DRUGVilazodone
Vilazodone, 20mg, oral administration once per day.
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female, 18 - 70 years of age * Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD) * Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)
Exclusion criteria
* Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control * History of meeting DSM-IV-TR criteria for any of the following: * Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode * Any depressive episode with psychotic or catatonic features * Panic disorder with or without agoraphobia * Obsessive-compulsive disorder * Schizophrenia, schizoaffective, or other psychotic disorder * Bulimia or anorexia nervosa * Presence of borderline personality disorder or antisocial personality disorder * Mental retardation, dementia, amnesia, or other significant cognitive disorders * Patients who are considered a suicide risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Baseline to Week 8 | The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Sheehan Disability Scale (SDS) Total Score | Baseline to Week 8 | The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Dose-matched placebo one per day, oral administration | 221 |
| Vilazadone 20mg Vilazodone 20mg once per day, oral administration. | 227 |
| Vilazodone 40mg Vilazodone 40mg once per day, oral administration | 225 |
| Total | 673 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 11 | 18 | 30 |
| Overall Study | Lack of Efficacy | 5 | 2 | 4 |
| Overall Study | Lost to Follow-up | 10 | 13 | 9 |
| Overall Study | Pregnancy | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 7 | 9 | 7 |
| Overall Study | Withdrawal by Subject | 8 | 9 | 16 |
Baseline characteristics
| Characteristic | Placebo | Vilazadone 20mg | Vilazodone 40mg | Total |
|---|---|---|---|---|
| Age, Continuous | 40.0 Years STANDARD_DEVIATION 13.7 | 40.6 Years STANDARD_DEVIATION 13.7 | 39.9 Years STANDARD_DEVIATION 13.3 | 40.2 Years STANDARD_DEVIATION 13.5 |
| Age, Customized < 20 | 6 Participants | 10 Participants | 4 Participants | 20 Participants |
| Age, Customized 20-29 | 59 Participants | 48 Participants | 59 Participants | 166 Participants |
| Age, Customized 30-39 | 50 Participants | 54 Participants | 50 Participants | 154 Participants |
| Age, Customized 40-49 | 43 Participants | 47 Participants | 50 Participants | 140 Participants |
| Age, Customized 50-59 | 44 Participants | 41 Participants | 46 Participants | 131 Participants |
| Age, Customized ≥ 60 | 19 Participants | 27 Participants | 16 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 25 Participants | 31 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 198 Participants | 202 Participants | 194 Participants | 594 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Black or African American | 35 Participants | 50 Participants | 46 Participants | 131 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 6 Participants | 6 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 174 Participants | 167 Participants | 167 Participants | 508 Participants |
| Sex/Gender, Customized Female | 143 Participants | 149 Participants | 142 Participants | 434 Participants |
| Sex/Gender, Customized Male | 78 Participants | 78 Participants | 83 Participants | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 221 | 0 / 227 | 0 / 225 |
| other Total, other adverse events | 85 / 221 | 123 / 227 | 121 / 225 |
| serious Total, serious adverse events | 1 / 221 | 1 / 227 | 0 / 225 |
Outcome results
Primary
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.
Time frame: Baseline to Week 8
Population: The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | 13.1 Score on scale | Standard Deviation 7.93 |
| Vilazadone 20mg | Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | 12.0 Score on scale | Standard Deviation 7.13 |
| Vilazodone 40mg | Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | 11.2 Score on scale | Standard Deviation 7.46 |
p-value: 0.08395% CI: [-2.71, 0.17]MMRM
p-value: 0.015695% CI: [-3.26, -0.34]MMRM
Secondary
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).
Time frame: Baseline to Week 8
Population: The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in the Sheehan Disability Scale (SDS) Total Score | 8.4 Score on Scale | Standard Deviation 7.53 |
| Vilazadone 20mg | Change From Baseline in the Sheehan Disability Scale (SDS) Total Score | 7.7 Score on Scale | Standard Deviation 6.51 |
| Vilazodone 40mg | Change From Baseline in the Sheehan Disability Scale (SDS) Total Score | 6.7 Score on Scale | Standard Deviation 6.62 |
p-value: 0.053695% CI: [-2.75, 0.02]MMRM
p-value: 0.034995% CI: [-2.94, -0.11]MMRM