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A Study of Aripiprazole in Patients With Major Depressive Disorder
NCT00105196 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00105196
The ClinicalTrials.gov registry entry for NCT00105196 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 349 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00105196 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Illinois, Georgia, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00105196?
The interventions under investigation include: Aripiprazole+ ADT (DRUG), Placebo+ ADT (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00105196?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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