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Sponsors and Collaborators: |
Bristol-Myers Squibb Otsuka America Pharmaceutical |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00261443 |
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.
Condition | Intervention | Phase |
---|---|---|
Depressive Disorder, Major |
Drug: Lithium or Valproate with PBO Drug: Lithium or Valproate with Aripiprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy |
Estimated Enrollment: | 1300 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A1: Placebo Comparator
/Active Comparator
|
Drug: Lithium or Valproate with PBO
Tablets, Oral, once daily lithium 250-2100 mg/day valproate 250-2500mg/day Placebo once daily |
A2: Experimental |
Drug: Lithium or Valproate with Aripiprazole
Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks) lithium 250-2100 mg/day valproate 250-2500mg/day aripiprazole 15-30 mg/day |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CN138-189 |
Study First Received: | December 1, 2005 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00261443 |
Health Authority: | United States: Food and Drug Administration |
Single or recurrent non-psychotic episode of Major Depressive Disorder |
Depression Mental Disorders Mood Disorders Lithium Carbonate Aripiprazole Depressive Disorder, Major |
Depressive Disorder Valproic Acid Lithium Recurrence Behavioral Symptoms |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors Antipsychotic Agents |
Antimanic Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses GABA Agents Central Nervous System Agents Antidepressive Agents Anticonvulsants |