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NCT00277212 · ClinicalTrials.gov registry record · Phase 4
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
A Phase 4 study of Bipolar Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,169
- Enrollment target
- 20
- Study locations
NCT00277212: Completed Phase 4 study of Bipolar Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00277212 is a Phase 4 study of Bipolar Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,169 participants, above the 325-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (260% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00277212, a Phase 4 study of Bipolar Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,169 participants
- Enrollment target
- 20
- Study locations
Study Summary
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
Primary Outcome
Time from randomization to relapse to a manic or mixed episode in the Double-Blind Relapse Assessment Phase as measured by the Proportion of Participants without Relapse Through Week 52 (Kaplan-Meier's estimated survival rate).
Conditions Studied
Interventions
- DRUG Lamotrigine + Aripiprazole
- DRUG Lamotrigine + Placebo
Study Locations (20)
California
- Pravin Kansagra, M.D. - Anaheim
- College Hospital Costa Mesa - Costa Mesa
- Pacific Institute For Medical Research, Inc. - Los Angeles
- Excell Research - Oceanside
- Southern Ca Clinical Research, Inc. - Pasadena
- Stanford University - Stanford
- Los Angeles Biomedical Research Institute - Torrance
- Pacific Clinical Research Medical Group - Upland
Florida
- Health Sciences America, Llc - Boca Raton
- Cns Clinical Research Group - Coral Springs
- Act Clinical Research Institute, Llc - Daytona Beach
- Neuropsychiatric Research Center Of Southwest Florida - Fort Myers
- Aurora-Cuervo Clinical Trials - Miami
- Gulf Coast Medical Research - Port Charlotte
- Janus Center For Psychiatric Research - West Palm Beach
Indiana
- Valle Vista Health System - Greenwood
- Clinco - Terre Haute
Alabama
- University Of Alabama At Birmingham - Birmingham
Arizona
- Southwest Biomedical Research Foundation - Tucson
Georgia
- Comprehensive Neuroscience, Inc - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,169 participants |
| Start Date | 2005-12 |
| Est. Completion | 2009-07 |
| Phase | Phase 4 |
What the finished NCT00277212 record still lists
NCT00277212 is an interventional study that assigns participants to a tested intervention. Its 1,169 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 (260% higher).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Lamotrigine + Aripiprazole is the first listed.
NCT00277212 names 20 study sites across 6 states, led by California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT00277212 about?
NCT00277212 is a clinical study titled "A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode". Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
What is the current status of trial NCT00277212?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,169 participants. The study started on 2005-12. Estimated completion is 2009-07.
What conditions does trial NCT00277212 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00277212?
The interventions under investigation include: Lamotrigine + Aripiprazole (DRUG), Lamotrigine + Placebo (DRUG).
Who is sponsoring clinical trial NCT00277212?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00277212 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. 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 NCT00277212's enrollment target sits among peer trials
1,169 9th of 162 higher than 154 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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