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NCT00683592 · ClinicalTrials.gov registry record · Phase 3
Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)
A Phase 3 study of Major Depressive Disorder, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 481
- Enrollment target
- 9
- Study locations
NCT00683592: Completed Phase 3 study of Major Depressive Disorder, sponsored by Forest Laboratories.
NCT00683592 is a Phase 3 study of Major Depressive Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 481 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (28% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00683592, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 481 participants
- Enrollment target
- 9
- Study locations
Study Summary
This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria.
Primary Outcome
The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression. The scale was constructed to be sensitive to treatment effects. The change from baseline in MADRS total score has a possible range of -60 to 60 where negative values reflect improvement in depression symptom severity. The method of last observation carried forward was utilized for subjects who discontinued prematurely.
Conditions Studied
Interventions
- DRUG placebo
- DRUG vilazodone
Study Locations (9)
Washington
- Northwest Clinical Research Center - Bellevue
- Summit Research Network - Seattle
California
- Pharmacology Research Institute - Newport Beach
Florida
- Florida Clinical Research Center - Bradenton
Georgia
- Atlanta Institute of Medicine and Research - Atlanta
Oregon
- Summit Research Network - Portland
Pennsylvania
- University of Pennsylvania Department of Psychiatry Mood and Anxiety Disorders - Philadelphia
Texas
- Mood Disorders Research Program and Clinic Exchange Park - Dallas
Utah
- University of Utah Health Sciences Ctr, Dept of Psychiatry Mood Disorders Clinic - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00683592 record still lists
NCT00683592 is an interventional study that assigns participants to a tested intervention. The registered 481 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 (28% 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.
NCT00683592 lists 9 locations in 8 states (Washington, California, Florida).
Frequently Asked Questions
What is clinical trial NCT00683592 about?
NCT00683592 is a clinical study titled "Randomized, Double-Blind, Placebo Controlled Study of Vilazodone's Efficacy, Safety, and Biomarkers of Response in Major Depressive Disorder (MDD)". This randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to evaluate genetic biomarkers of treatment response associated with vilazodone use in adult patients diagnosed with MDD by the DSM-IV-TR criteria.
What is the current status of trial NCT00683592?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 481 participants. The study started on 2008-03. Estimated completion is 2009-03.
What conditions does trial NCT00683592 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT00683592?
The interventions under investigation include: placebo (DRUG), vilazodone (DRUG).
Who is sponsoring clinical trial NCT00683592?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00683592 being conducted?
This trial has 9 study locations across California, Florida, Georgia, Oregon, Pennsylvania. 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 NCT00683592's enrollment target sits among peer trials
481 35th of 282 higher than 248 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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