Major Depressive Disorder
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive disorder.
Interventions
DRUGPlacebo
Dose matched placebo tablets, once per day, oral administration.
DRUGVilazodone
Vilazodone tablets, 15 mg per day, oral administration
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female outpatients between 12-17 years of age * Primary diagnosis of major depressive disorder (MDD) * Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater * Clinical Global Impressions-Severity (CGI-S) score of 4 or greater
Exclusion criteria
* Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment. * History of suicidal behavior, or requires precaution against suicide * Not generally healthy medical condition * Seizure disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score | From Baseline to week 8 | The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Global Impressions-Severity (CGI-S) Score | From Baseline to Week 8 | The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients. |
Countries
United States
Participant flow
Pre-assignment details
Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study
Participants by arm
| Arm | Count |
|---|---|
| Placebo Dose-matched placebo tablets, once per day, oral administration | 171 |
| Vilazodone 15 mg 15 mg vilazodone tablets, once per day, oral administration | 175 |
| Vilazodone 30 mg 30 mg vilazodone tablets, once per day, oral administration | 180 |
| Total | 526 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-blind Down-Taper Period | Withdrawal by Subject | 5 | 8 | 4 |
| Double-blind Treatment Period | Adverse Event | 4 | 9 | 8 |
| Double-blind Treatment Period | Lack of Efficacy | 5 | 3 | 0 |
| Double-blind Treatment Period | Lost to Follow-up | 6 | 3 | 1 |
| Double-blind Treatment Period | Other Reasons | 2 | 0 | 0 |
| Double-blind Treatment Period | Protocol Violation | 3 | 4 | 2 |
| Double-blind Treatment Period | Withdrawal by Subject | 9 | 7 | 8 |
| Randomized | Adverse Event | 1 | 0 | 0 |
| Randomized | Lost to Follow-up | 1 | 0 | 0 |
| Randomized | Protocol Violation | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Vilazodone 15 mg | Vilazodone 30 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 14.9 Years STANDARD_DEVIATION 1.7 | 14.9 Years STANDARD_DEVIATION 1.6 | 14.6 Years STANDARD_DEVIATION 1.6 | 14.8 Years STANDARD_DEVIATION 1.6 |
| BMI | 25.97 kg/m2 STANDARD_DEVIATION 7.15 | 25.30 kg/m2 STANDARD_DEVIATION 6.86 | 25.66 kg/m2 STANDARD_DEVIATION 6.7 | 25.64 kg/m2 STANDARD_DEVIATION 6.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 22 Participants | 19 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 150 Participants | 153 Participants | 161 Participants | 464 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 | 2 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 3 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 45 Participants | 48 Participants | 49 Participants | 142 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 7 Participants | 6 Participants | 21 Participants |
| Race/Ethnicity, Customized White | 110 Participants | 115 Participants | 121 Participants | 346 Participants |
| Sex: Female, Male Female | 103 Participants | 103 Participants | 107 Participants | 313 Participants |
| Sex: Female, Male Male | 68 Participants | 72 Participants | 73 Participants | 213 Participants |
| Weight | 71.87 kg STANDARD_DEVIATION 20.78 | 70.10 kg STANDARD_DEVIATION 20.65 | 70.89 kg STANDARD_DEVIATION 20.58 | 70.95 kg STANDARD_DEVIATION 20.64 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 171 | 0 / 175 | 0 / 180 |
| other Total, other adverse events | 63 / 171 | 81 / 175 | 97 / 180 |
| serious Total, serious adverse events | 1 / 171 | 2 / 175 | 3 / 180 |
Outcome results
Primary
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.
Time frame: From Baseline to week 8
Population: The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score | -22.48 units on a scale | Standard Error 0.921 |
| Vilazodone 15 mg | Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score | -22.94 units on a scale | Standard Error 0.904 |
| Vilazodone 30 mg | Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score | -24.22 units on a scale | Standard Error 0.872 |
Secondary
Change in Clinical Global Impressions-Severity (CGI-S) Score
The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.
Time frame: From Baseline to Week 8
Population: The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Clinical Global Impressions-Severity (CGI-S) Score | -1.60 units on a scale | Standard Error 0.094 |
| Vilazodone 15 mg | Change in Clinical Global Impressions-Severity (CGI-S) Score | -1.82 units on a scale | Standard Error 0.092 |
| Vilazodone 30 mg | Change in Clinical Global Impressions-Severity (CGI-S) Score | -1.87 units on a scale | Standard Error 0.089 |