Study of Aripiprazole in Patients With Bipolar I Disorder
Phase 3
Completed
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00257972
- Brief Summary
The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Clinical diagnosis of bipolar I disorder, manic or mixed episode
Exclusion Criteria
- First manic or mixed episode
- Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole
- Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline to endpoint in a mania rating scale
- Secondary Outcome Measures
Name Time Method Response rate and Clinical Global Impression Scale at endpoint
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie aripiprazole's efficacy in bipolar I disorder treatment?
How does aripiprazole compare to other antipsychotics in managing bipolar mania with mood stabilizers?
Are there specific biomarkers that predict response to aripiprazole in bipolar I patients with treatment-resistant mania?
What are the potential adverse events associated with aripiprazole-lithium or valproate combinations in bipolar I disorder?
How do aripiprazole's dopamine modulating effects influence its role in the broader therapeutic landscape of bipolar disorder?
Trial Locations
- Locations (1)
Local Institution
🇬🇧Surbiton, Middlesex, United Kingdom
Local Institution🇬🇧Surbiton, Middlesex, United Kingdom