The purpose of this study is to determine whether cariprazine is safe and effective in the treatment of patients with acute mania associated with Bipolar I disorder.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Acute Mania associated with Bipolar I Disorder
- Registration Number
- CTRI/2010/091/000140
- Lead Sponsor
- Forest Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 320
Inclusion Criteria
(1) Male or female inpatient, 18 to 65 years of age
(2) Patients who have provided informed consent prior to any study specific procedures
(3) Patients currently meeting the DSM-IV-TR criteria for bipolar I disorder as confirmed by the SCID, manic or mixed type with or without psychotic symptoms
(4) Voluntarily hospitalized for current manic episode
Exclusion Criteria
(1) Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
(2) Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/ or ECG
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Young Mania Rating Scale (YMRS)Timepoint: 3 Weeks
- Secondary Outcome Measures
Name Time Method Clinical Global Impression-Severity (CGI-S)Timepoint: 3 Weeks