ADHD, Attention-Deficit/Hyperactivity Disorder
Conditions
Keywords
Adult ADHD, Attention-Deficit/Hyperactivity Disorder
Brief summary
The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.
Interventions
DRUGTD-9855
Once daily
DRUGPlacebo
Once daily
Sponsors
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must meet the following ADHD diagnostic and inclusion criteria: * Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current ADHD subtypes (ADHD combined type, ADHD predominately inattentive type, ADHD predominately hyperactive-impulsive type) as assessed by the clinical interview and confirmed by Adult Attention-Deficit/Hyperactivity Disorder Clinical Diagnostic Scale (ACDS V1.2). * Subjects must have a total score of 24 or greater on the AISRS at both the Screening and Baseline Visits AND the Baseline Visit AISRS scores must not vary by more than 20% from Screening. * Subjects are required to have CGI-S score ≥4 (moderate) at both the Screening and Baseline Visits. Subjects should have at least moderate severity for ADHD symptoms. * For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0. All female subjects of childbearing potential must be using a highly effective method of birth control during the study and for at least 1 month after completion of study drug dosing. * A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \<1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device \[IUD\] with documented failure rate of \<1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with a barrier method. * Women are considered to be not of childbearing potential if they have had a total hysterectomy or bilateral tubal ligation (documentation for either must be provided before enrollment) or are at least 2 years postmenopausal. Female subjects cannot be breast-feeding.
Exclusion criteria
Any current psychiatric disorder other than ADHD as defined in DSM-IV-TR as assessed by Mini International Neuropsychiatric Interview (MINI). Subjects with dysthymia that does not require pharmacological treatment will not be excluded. * MADRS total score \>15. * A diagnosis of ADHD NOS. * Any diagnosis of lifetime bipolar disorder or psychotic disorder * A current diagnosis of any severe comorbid Axis II disorder * Any history of mental retardation, organic mental disorders due to general medical condition or pervasive developmental disorder as defined by DSM-IV-TR.-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in AISRS Total Score at Day 42 | Baseline and Day 42 | The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54 with a negative change from baseline indicating an improvement in severity/reduction in symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in AISRS Inattentive Subscale at Day 42 | Baseline and Day 42 | The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS inattentive subscale that measures all 9 inattentive symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The AISRS inattentive subscale score ranges from 0 to 27 with a negative change from baseline indicating an improvement in severity/reduction in symptoms. |
| Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42 | Baseline and Day 42 | The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS hyperactive-impulsive subscale measures all 9 hyperactive/impulsive symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The AISRS hyperactive-impulsive subscale score ranges from 0 to 27 with a negative change from baseline indicating an improvement in severity/reduction in symptoms. |
| Percentage of Participants With an AISRS Response at Day 42 | Day 42 | The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS total scale measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54. A responder is defined as a participant with \>=30% reduction from baseline in AISRS total score. |
| Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42 | Baseline and Day 42 | The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participants' illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7,extremely ill. A negative change from baseline indicates a reduction in illness. |
| Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42 | Baseline and Day 42 | The ASRS is a checklist consisting of the 18 Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV-TR) criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS total score ranges from 0-72 with a negative change from baseline indicating a reduction in frequency of symptoms. |
| Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42 | Baseline and Day 42 | The BDEFS-SF: Self-Report is an empirically based tool for evaluating dimensions of adult executive functioning in daily life. The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80 with a negative change from baseline indicating an improvement in functioning. |
| Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42 | Baseline and Day 42 | The ASRS hyperactive-impulsive subscale is a checklist consisting of 9 DSM-IV-TR hyperactive/impulsive criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS hyperactive-impulsive subscale score ranges from 0-36 with a negative change from baseline indicating a reduction in frequency of symptoms. |
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42 | Baseline and Day 42 | MADRS is a 10-item investigator-rated scale that assesses the range of symptoms that are most frequently observed in patients with major depression. The 10 selected items are rated on a scale of 0 (no depression) to 6 (highest level of depression) with anchors at 2-point intervals. Total scores on the MADRS range from 0 to 60 with a negative change from baseline indicating an improvement in levels of depression. |
| Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42 | Baseline and Day 42 | The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80. A reliable change is defined as a decrease in total BDEFS-SF score of 12 or more relative to the baseline value. |
| Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42 | Baseline and Day 42 | The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80. A reliable change is defined as a decrease in total BDEFS-SF score of 12 or more relative to the baseline value. Normalization is defined as a post-baseline BDEFS-SF total score \<45. |
| Change From Baseline in BDEFS-SF Symptom Count at Day 42 | Baseline and Day 42 | The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. A negative change from baseline in symptom count indicates an improvement in functioning. Only symptoms rated as occurring often or very often on the BDEFS-SF are included in the symptom count. Mean change from baseline in symptom count is reported |
| Change From Baseline in ASRS Inattentive Subscale at Day 42 | Baseline and Day 42 | The ASRS inattentive subscale is a checklist consisting of 9 DSM-IV-TR inattentive criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS inattentive subscale score ranges from 0-36 with a negative change from baseline indicating a reduction in frequency of symptoms. |
Countries
United States
Participant flow
Recruitment details
295 participants with attention-deficit/hyperactivity disorder (ADHD) were enrolled across 19 sites in the United States between December 2011 and September 2013. Participants were randomized in a 1:1:1 ratio, to receive active treatment, consisting of 5 mg or 20 mg of TD-9855 or placebo daily for 6 weeks.
Pre-assignment details
A total of 295 subjects were randomized into the study and 293 received any amount of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received a matching placebo as oral capsules daily from Day 1 to Day 42. | 97 |
| TD-9855 5mg Participants received 5 mg TD-9855 as oral capsules daily from Day 1 to Day 42. | 99 |
| TD-9855 20 mg Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42. | 99 |
| Total | 295 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 | 2 |
| Overall Study | Lost to Follow-up | 3 | 3 | 10 |
| Overall Study | Miscellaneous | 0 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 1 | 2 |
| Overall Study | Protocol Violation | 6 | 6 | 5 |
| Overall Study | Withdrawal by Subject | 12 | 6 | 4 |
Baseline characteristics
| Characteristic | Placebo | TD-9855 5mg | TD-9855 20 mg | Total |
|---|---|---|---|---|
| Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score | 38.4 score on a scale STANDARD_DEVIATION 7.1 | 39.1 score on a scale STANDARD_DEVIATION 7.3 | 38.2 score on a scale STANDARD_DEVIATION 7.1 | 38.6 score on a scale STANDARD_DEVIATION 7.2 |
| Age, Continuous | 30.8 years STANDARD_DEVIATION 7.9 | 30.9 years STANDARD_DEVIATION 7.4 | 30.5 years STANDARD_DEVIATION 7.6 | 30.8 years STANDARD_DEVIATION 7.6 |
| Barkley Deficits in Executive Functioning Scale - Short Form (BDEFS-SF): Self Report Total Score | 52.7 score on a scale STANDARD_DEVIATION 11.9 | 53.0 score on a scale STANDARD_DEVIATION 10.5 | 52.3 score on a scale STANDARD_DEVIATION 10.3 | 52.7 score on a scale STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 14 Participants | 16 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 85 Participants | 82 Participants | 251 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 9 Participants | 12 Participants | 30 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 88 Participants | 86 Participants | 84 Participants | 258 Participants |
| Sex: Female, Male Female | 30 Participants | 41 Participants | 33 Participants | 104 Participants |
| Sex: Female, Male Male | 67 Participants | 58 Participants | 66 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 98 | 0 / 98 |
| other Total, other adverse events | 68 / 97 | 75 / 98 | 80 / 98 |
| serious Total, serious adverse events | 1 / 97 | 0 / 98 | 0 / 98 |
Outcome results
Primary
Change From Baseline in AISRS Total Score at Day 42
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in AISRS Total Score at Day 42 | -12.1 score on a scale | Standard Error 1.21 |
| TD-9855 5mg | Change From Baseline in AISRS Total Score at Day 42 | -11.7 score on a scale | Standard Error 1.17 |
| TD-9855 20 mg | Change From Baseline in AISRS Total Score at Day 42 | -12.2 score on a scale | Standard Error 1.18 |
p-value: 0.6026Mixed Model for Repeated Measures (MMRM)
p-value: 0.4844MMRM
Secondary
Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42
The ASRS is a checklist consisting of the 18 Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV-TR) criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS total score ranges from 0-72 with a negative change from baseline indicating a reduction in frequency of symptoms.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42 | -12.5 score on a scale | Standard Deviation 15.25 |
| TD-9855 5mg | Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42 | -12.1 score on a scale | Standard Deviation 14.49 |
| TD-9855 20 mg | Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42 | -14.0 score on a scale | Standard Deviation 13.89 |
Secondary
Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS hyperactive-impulsive subscale measures all 9 hyperactive/impulsive symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The AISRS hyperactive-impulsive subscale score ranges from 0 to 27 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42 | -5.2 score on a scale | Standard Deviation 5.17 |
| TD-9855 5mg | Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42 | -5.1 score on a scale | Standard Deviation 5.51 |
| TD-9855 20 mg | Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42 | -5.0 score on a scale | Standard Deviation 5.11 |
Secondary
Change From Baseline in AISRS Inattentive Subscale at Day 42
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS inattentive subscale that measures all 9 inattentive symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The AISRS inattentive subscale score ranges from 0 to 27 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in AISRS Inattentive Subscale at Day 42 | -6.2 score on a scale | Standard Deviation 6.58 |
| TD-9855 5mg | Change From Baseline in AISRS Inattentive Subscale at Day 42 | -6.8 score on a scale | Standard Deviation 6.57 |
| TD-9855 20 mg | Change From Baseline in AISRS Inattentive Subscale at Day 42 | -7.2 score on a scale | Standard Deviation 6.72 |
Secondary
Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42
The ASRS hyperactive-impulsive subscale is a checklist consisting of 9 DSM-IV-TR hyperactive/impulsive criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS hyperactive-impulsive subscale score ranges from 0-36 with a negative change from baseline indicating a reduction in frequency of symptoms.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42 | -5.9 score on a scale | Standard Deviation 7.62 |
| TD-9855 5mg | Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42 | -5.2 score on a scale | Standard Deviation 6.94 |
| TD-9855 20 mg | Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42 | -6.3 score on a scale | Standard Deviation 6.71 |
Secondary
Change From Baseline in ASRS Inattentive Subscale at Day 42
The ASRS inattentive subscale is a checklist consisting of 9 DSM-IV-TR inattentive criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS inattentive subscale score ranges from 0-36 with a negative change from baseline indicating a reduction in frequency of symptoms.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in ASRS Inattentive Subscale at Day 42 | -6.7 score on a scale | Standard Deviation 8.3 |
| TD-9855 5mg | Change From Baseline in ASRS Inattentive Subscale at Day 42 | -6.9 score on a scale | Standard Deviation 8.26 |
| TD-9855 20 mg | Change From Baseline in ASRS Inattentive Subscale at Day 42 | -7.7 score on a scale | Standard Deviation 7.99 |
Secondary
Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42
The BDEFS-SF: Self-Report is an empirically based tool for evaluating dimensions of adult executive functioning in daily life. The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80 with a negative change from baseline indicating an improvement in functioning.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis and with a with baseline BDEFS-SF Total Score \>= 45 are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42 | -9.8 score on a scale | Standard Error 1.56 |
| TD-9855 5mg | Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42 | -9.7 score on a scale | Standard Error 1.51 |
| TD-9855 20 mg | Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42 | -11.6 score on a scale | Standard Error 1.49 |
p-value: 0.5269MMRM
p-value: 0.2092MMRM
Secondary
Change From Baseline in BDEFS-SF Symptom Count at Day 42
The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. A negative change from baseline in symptom count indicates an improvement in functioning. Only symptoms rated as occurring often or very often on the BDEFS-SF are included in the symptom count. Mean change from baseline in symptom count is reported
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in BDEFS-SF Symptom Count at Day 42 | -3.3 count of symptoms | Standard Deviation 4.86 |
| TD-9855 5mg | Change From Baseline in BDEFS-SF Symptom Count at Day 42 | -4.2 count of symptoms | Standard Deviation 5.72 |
| TD-9855 20 mg | Change From Baseline in BDEFS-SF Symptom Count at Day 42 | -4.5 count of symptoms | Standard Deviation 5.1 |
Secondary
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participants' illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7,extremely ill. A negative change from baseline indicates a reduction in illness.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42 | -1.0 score on a scale | Standard Deviation 1.09 |
| TD-9855 5mg | Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42 | -0.8 score on a scale | Standard Deviation 1.13 |
| TD-9855 20 mg | Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42 | -1.0 score on a scale | Standard Deviation 1.13 |
Secondary
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42
MADRS is a 10-item investigator-rated scale that assesses the range of symptoms that are most frequently observed in patients with major depression. The 10 selected items are rated on a scale of 0 (no depression) to 6 (highest level of depression) with anchors at 2-point intervals. Total scores on the MADRS range from 0 to 60 with a negative change from baseline indicating an improvement in levels of depression.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42 | -1.3 score on a scale | Standard Deviation 3.54 |
| TD-9855 5mg | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42 | -0.3 score on a scale | Standard Deviation 3.25 |
| TD-9855 20 mg | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42 | -0.9 score on a scale | Standard Deviation 2.86 |
Secondary
Percentage of Participants With an AISRS Response at Day 42
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS total scale measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54. A responder is defined as a participant with \>=30% reduction from baseline in AISRS total score.
Time frame: Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With an AISRS Response at Day 42 | 46.1 percentage of participants |
| TD-9855 5mg | Percentage of Participants With an AISRS Response at Day 42 | 43.9 percentage of participants |
| TD-9855 20 mg | Percentage of Participants With an AISRS Response at Day 42 | 51.9 percentage of participants |
Secondary
Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42
The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80. A reliable change is defined as a decrease in total BDEFS-SF score of 12 or more relative to the baseline value. Normalization is defined as a post-baseline BDEFS-SF total score \<45.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis and with a with baseline BDEFS-SF Total Score \>= 45 are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42 | 29.0 percentage of participants |
| TD-9855 5mg | Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42 | 28.8 percentage of participants |
| TD-9855 20 mg | Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42 | 38.2 percentage of participants |
Secondary
Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42
The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80. A reliable change is defined as a decrease in total BDEFS-SF score of 12 or more relative to the baseline value.
Time frame: Baseline and Day 42
Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42 | 30.4 percentage of participants |
| TD-9855 5mg | Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42 | 32.6 percentage of participants |
| TD-9855 20 mg | Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42 | 47.6 percentage of participants |