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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00277212
The ClinicalTrials.gov registry entry for NCT00277212 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,169 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 (260% 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 Lamotrigine + Aripiprazole is the first listed.
NCT00277212 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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