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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: Completed Phase 4 study of Bipolar Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: hospitalization for a manic, mixed or depressive episode; serious adverse event of worsening disease under study accompanied by a Y-MRS \> 16 and/or a MADRS \> 16; discontinuation due to lack of efficacy as determined by the investigator accompanied by a Y-MRS \> 16 and/or a MADRS \> 16.
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 |
What the finished NCT00261443 record still lists
NCT00261443 is an interventional study that assigns participants to a tested intervention. Its 1,270 participants enrollment target places it among the larger protocols in the corpus, above the 325-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (291% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Bipolar 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 NCT00261443's enrollment target sits among peer trials
1,270 6th of 162 higher than 157 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar 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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