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NCT01878292 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 529
- Enrollment target
- 20
- Study locations
NCT01878292: Completed Phase 3 study of Major Depressive Disorder, sponsored by Forest Laboratories.
NCT01878292 is a Phase 3 study of Major Depressive Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 529 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (41% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01878292, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 529 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vilazodone
Study Locations (20)
Florida
- Forest Investigative Site 039 - Gainesville
- Forest Investigative Site 009 - Jacksonville Beach
- Forest Investigative Site 063 - Miami
- Forest Investigative Site 034 - Oakland Park
- Forest Investigative Site 016 - Orlando
- Forest Investigative Site 064 - Orlando
California
- Forest Investigative Site 073 - Imperial
- Forest Investigative Site 052 - Los Angeles
- Forest Investigative Site 023 - Murrieta
- Forest Investigative Site 004 - Orange
- Forest Investigative Site 037 - San Diego
Georgia
- Forest Investigative Site 014 - Atlanta
- Forest Investigative Site 030 - Roswell
Illinois
- Forest Investigative Site 032 - Libertyville
- Forest Investigative Site 048 - Naperville
District of Columbia
- Forest Investigative Site 006 - Washington D.C.
Indiana
- Forest Investigative Site 051 - Terre Haute
Kansas
- Forest Investigative Site 013 - Overland Park
Louisiana
- Forest Investigative Site 070 - Lake Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 529 participants |
| Start Date | 2013-07-11 |
| Est. Completion | 2016-10-05 |
| Phase | Phase 3 |
What the finished NCT01878292 record still lists
NCT01878292 is an interventional study that assigns participants to a tested intervention. The registered 529 participants enrollment target is mid-sized for trials with a published cap, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (41% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01878292 names 20 study sites across 9 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01878292 about?
NCT01878292 is a clinical study titled "Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder". 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.
What is the current status of trial NCT01878292?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2013-07-11. Estimated completion is 2016-10-05.
What conditions does trial NCT01878292 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT01878292?
The interventions under investigation include: Placebo (DRUG), Vilazodone (DRUG).
Who is sponsoring clinical trial NCT01878292?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01878292 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01878292's enrollment target sits among peer trials
529 29th of 282 higher than 254 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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