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NCT00105196 · ClinicalTrials.gov registry record · Phase 3
A Study of Aripiprazole in Patients With Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 349
- Enrollment target
- 20
- Study locations
NCT00105196: Completed Phase 3 study of Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00105196 is a Phase 3 study of Major Depressive Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 349 participants, roughly in line with the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00105196, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 349 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.
Primary Outcome
Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Conditions Studied
Interventions
- DRUG Aripiprazole+ ADT
- DRUG Placebo+ ADT
Study Locations (20)
Illinois
- Uptown Research Institute, Llc - Chicago
- Cunningham Clinical Research, Llc - Edwardsville
- Comprehensive Neuroscience, Inc. - Hoffman Estates
- Vine Street Clinical Research Center - Springfield
Georgia
- Medical College Of Georgia - Augusta
- Carman Research - Smyrna
Michigan
- Summit Research Network - Farmington Hills
- Summit Research Network - Flint
Minnesota
- University Of Minnesota - Minneapolis
- Regions Hospital - Saint Paul
Alabama
- University Of Alabama At Birmingham - Birmingham
California
- Sharp Mesa Vista Hospital - San Diego
District of Columbia
- George Washington University Medical Center - Washington D.C.
Florida
- Cns Clinical Research Group - Coral Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 349 participants |
| Start Date | 2005-03 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00105196 record still lists
NCT00105196 is an interventional study that assigns participants to a tested intervention. The registered 349 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Aripiprazole+ ADT is the first listed.
NCT00105196 names 20 study sites across 14 states, led by Illinois, Georgia, Michigan.
Frequently Asked Questions
What is clinical trial NCT00105196 about?
NCT00105196 is a clinical study titled "A Study of Aripiprazole in Patients With Major Depressive Disorder". The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomp...
What is the current status of trial NCT00105196?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 349 participants. The study started on 2005-03. Estimated completion is 2008-03.
What conditions does trial NCT00105196 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT00105196?
The interventions under investigation include: Aripiprazole+ ADT (DRUG), Placebo+ ADT (DRUG).
Who is sponsoring clinical trial NCT00105196?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00105196 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. 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 NCT00105196's enrollment target sits among peer trials
349 47th of 282 higher than 236 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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