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NCT00261443 · ClinicalTrials.gov registry record · Phase 4
A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
A Phase 4 study of Bipolar Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,270
- Enrollment target
- 20
- Study locations
NCT00261443 is a Phase 4 study of Bipolar Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,270 participants, above the 325-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (291% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT00261443, a Phase 4 study of Bipolar Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,270 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.
Conditions Studied
Interventions
- DRUG Lithium or Valproate with placebo (PBO)
- DRUG Lithium or Valproate with Aripiprazole
Study Locations (20)
California
- Pravin Kansagra, M.D. - Anaheim
- Psychopharmacology Research Network Of Torrance - Cerritos
- Atp Clinical Research, Inc. - Costa Mesa
- Us Clinical Research Centers, Llc - Costa Mesa
- Va Long Beach Healthcare System - Long Beach
- Synergy Clinical Research Center - National City
- University Of California, Irvine Medical Center - Orange
New York
- Neuropsychiatric Research Associates - New York
- Behavioral Medical Research Of Staten Island - Staten Island
- Richmond Behavioral Associates - Staten Island
Florida
- Clinical Neuroscience Solutions, Inc. - Orlando
- University Of South Florida - Tampa
Ohio
- Rakesh Ranjan, Md & Associates, Inc. - Beachwood
- University Of Cincinnati Medical Center - Cincinnati
Alabama
- Tuscaloosa Va Medical Center - Tuscaloosa
Georgia
- Carman Research - Smyrna
Massachusetts
- University Of Massachusetts Medical School - Worcester
Missouri
- Psych Care Consultants Research - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,270 participants |
| Start Date | 2005-09 |
| Est. Completion | 2009-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00261443
The ClinicalTrials.gov registry entry for NCT00261443 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,270 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 325-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (291% higher). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Lithium or Valproate with placebo (PBO) is the first listed.
NCT00261443 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT00261443 about?
NCT00261443 is a clinical study titled "A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania". The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.
What is the current status of trial NCT00261443?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,270 participants. The study started on 2005-09. Estimated completion is 2009-10.
What conditions does trial NCT00261443 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00261443?
The interventions under investigation include: Lithium or Valproate with placebo (PBO) (DRUG), Lithium or Valproate with Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00261443?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00261443 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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