Study to Evaluate the Efficacy and Safety of Aripiprazole in Combination With Lithium or Valproate Over 12 Weeks in the Treatment of Patients Diagnosed With Bipolar I Disorder Mania
Tracking Information
Start Date ICMJE | June 2008 |
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Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: August 13, 2008) | Mean change in the YMRS Total score [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: April 22, 2008) | Mean change in the YMRS Total score [ Time Frame: from baseline to Week 12 ] |
Change History | Complete list of historical versions of study NCT00665366 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: August 13, 2008) | Mean change in the CGI-BP Severity of Illness, PGI-I, FAST & LIFE-RIFT scores, vital signs, labs, ECGs & physical measurements (height, weight) [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE (submitted: April 22, 2008) | Mean change in the CGI-BP Severity of Illness, PGI-I, FAST & LIFE-RIFT scores, vital signs, labs, ECGs & physical measurements (height, weight) [ Time Frame: from baseline to Week 12 ] |
Descriptive Information
Brief Title ICMJE | Study to Evaluate the Efficacy and Safety of Aripiprazole in Combination With Lithium or Valproate Over 12 Weeks in the Treatment of Patients Diagnosed With Bipolar I Disorder Mania |
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Official Title ICMJE | A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement |
Brief Summary | The purpose of the study is to determine if aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Condition ICMJE | Bipolar Disorder Mania |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 388 | ||||||||
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Estimated Completion Date | February 2011 | ||||||||
Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Austria, Czech Republic, France, Germany, Greece, Hungary, Italy, Poland, Romania, Russian Federation, South Africa, Spain, Turkey |
Administrative Information
NCT ID ICMJE | NCT00665366 | ||||
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Responsible Party | Study Director, Bristol-Myers Squibb | ||||
Study ID Numbers ICMJE | CN138-502, EudraCT number 2007-005959-42 | ||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
Collaborators ICMJE | Otsuka America Pharmaceutical | ||||
Investigators ICMJE |
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Information Provided By | Bristol-Myers Squibb |
Source: http://clinicaltrials.gov/