A Phase 3 interventional study of Vilazodone and Placebo in Major Depressive Disorder, sponsored by Forest Laboratories. Completed at 60 sites in 2 countries. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 473 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vilazodone tablets, 5mg, 10mg and 20mg. Oral administration, once per day.
Drug: Vilazodone
Dose-matched placebo tablets or capsules, oral administration, once per day.
Drug: Placebo
Fluoxetine capsules, 10mg and 20 mg. Oral administration, once per day.
Drug: Fluoxetine
Also known as: Viibryd
Also known as: Prozac
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
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
| Milestone | Placebo | Vilazodone | Fluoxetine |
|---|---|---|---|
| Started | 186 | 187 | 97 |
| Completed | 152 | 155 | 82 |
| Not completed | 34 | 32 | 15 |
| Withdrew: Adverse event | 3 | 10 | 6 |
| Withdrew: Insufficient therapeutic response | 2 | 2 | 0 |
| Withdrew: Withdrawal by subject | 10 | 10 | 2 |
| Withdrew: Lost to follow-up | 11 | 5 | 3 |
| Withdrew: Protocol violation | 3 | 0 | 0 |
| Withdrew: Non-compliance with study drug | 4 | 4 | 4 |
| Withdrew: Miscellaneous reasons | 1 | 1 | 0 |
| Milestone | Placebo | Vilazodone | Fluoxetine |
|---|---|---|---|
| Started | 152 | 159 | 82 |
| Completed | 151 | 157 | 80 |
| Not completed | 1 | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 | 2 |
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.
| units on a scale | Placebo | Vilazodone | Fluoxetine |
|---|---|---|---|
| Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score | -20.32 ± 0.983 | -20.72 ± 0.977 | -22.71 ± 1.320 |
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.
| units on a scale | Placebo | Vilazodone | Fluoxetine |
|---|---|---|---|
| Change in Clinical Global Impressions-Severity (CGI-S) Score | -1.52 ± 0.097 | -1.57 ± 0.096 | -1.72 ± 0.130 |
Collected over Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/186 (0%) | 1/186 (0.5%) | 54/186 (29%) |
| Vilazodone | 0/187 (0%) | 0/187 (0%) | 97/187 (51.9%) |
| Fluoxetine | 0/97 (0%) | 6/97 (6.2%) | 27/97 (27.8%) |
| Event | Placebo | Vilazodone | Fluoxetine |
|---|---|---|---|
| Suicidal ideationPsychiatric disorders | 0/186 | 0/187 | 3/97 |
| Depressive symptomPsychiatric disorders | 0/186 | 0/187 | 1/97 |
| Hallucination, auditoryPsychiatric disorders | 0/186 | 0/187 | 1/97 |
| OverdoseInjury, poisoning and procedural complications | 0/186 | 0/187 | 1/97 |
| Croup infectiousInfections and infestations | 1/186 | 0/187 | 0/97 |
| Event | Placebo | Vilazodone | Fluoxetine |
|---|---|---|---|
| NauseaGastrointestinal disorders | 13/186 | 40/187 | 6/97 |
| HeadacheNervous system disorders | 31/186 | 24/187 | 10/97 |
| VomitingGastrointestinal disorders | 7/186 | 24/187 | 4/97 |
| DiarrhoeaGastrointestinal disorders | 6/186 | 16/187 | 2/97 |
| Abdominal pain upperGastrointestinal disorders | 6/186 | 13/187 | 4/97 |
| SomnolenceNervous system disorders | 4/186 | 12/187 | 2/97 |
| InsomniaPsychiatric disorders | 3/186 | 10/187 | 6/97 |
| DizzinessNervous system disorders | 5/186 | 10/187 | 2/97 |
| Upper respiratory tract infectionInfections and infestations | 5/186 | 6/187 | 5/97 |
The Safety Population will consist of all patients in the Randomized Population who received at least 1 dose of double-blind investigational product.
| Age, Continuous(Years) | Placebo | Vilazodone | Fluoxetine | Total |
|---|---|---|---|---|
| Mean | 13 ± 2.9 | 13 ± 2.9 | 13.2 ± 2.8 | 13 ± 2.9 |
| Age, Customized(Participants) | Placebo | Vilazodone | Fluoxetine | Total |
|---|---|---|---|---|
| 7-11 | 61 | 55 | 30 | 146 |
| 12-17 | 125 | 132 | 67 | 324 |
| Sex: Female, Male(Participants) | Placebo | Vilazodone | Fluoxetine | Total |
|---|---|---|---|---|
| Female | 106 | 126 | 51 | 283 |
| Male | 80 | 61 | 46 | 187 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Vilazodone | Fluoxetine | Total |
|---|---|---|---|---|
| Hispanic or Latino | 27 | 25 | 12 | 64 |
| Not Hispanic or Latino | 159 | 162 | 85 | 406 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | Vilazodone | Fluoxetine | Total |
|---|---|---|---|---|
| White | 118 | 121 | 60 | 299 |
| Black or African American | 57 | 58 | 30 | 145 |
| Asian | 5 | 1 | 1 | 7 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 2 | 0 | 3 |
| Other | 5 | 5 | 5 | 15 |
| Missing | 0 | 0 | 1 | 1 |
| Weight(kg) | Placebo | Vilazodone | Fluoxetine | Total |
|---|---|---|---|---|
| Mean | 59.13 ± 24.29 | 61.35 ± 24.79 | 59.38 ± 21.14 | 60.07 ± 23.86 |
| Body Mass Index (BMI)(kg/m2) | Placebo | Vilazodone | Fluoxetine | Total |
|---|---|---|---|---|
| Mean | 23.31 ± 6.85 | 24.25 ± 7.58 | 23.48 ± 6.66 | 23.72 ± 7.11 |
| CDRS-R total score(units on a scale) | Placebo | Vilazodone | Fluoxetine | Total |
|---|---|---|---|---|
| Mean | 57.3 ± 9.2 | 58.3 ± 9.2 | 58 ± 8.8 | 57.8 ± 9.1 |
1 further baseline measures are reported on the registry.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Forest Laboratories