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  ICMJEJune 2008
Estimated Primary Completion DateFebruary 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 HistoryComplete 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  ICMJEStudy 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
Official Title  ICMJEA 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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition  ICMJEBipolar Disorder Mania
Intervention  ICMJE
  • Drug: Aripiprazole
    5 mg, 10 mg or 15 mg oral tablets and administered at starting dose of 5 mg/day for Week 1, uptitrated to 10 mg/day for Weeks 2 and 3, 15 mg/day for Weeks 4, 5 and 6 and then flexible dose of either 15 or 30 mg/day for Weeks 7 to 12, once daily, 12 weeks
    Other Names:
    • Abilify
    • BMS-337039
  • Drug: Placebo
    Tablets, Oral, 0 mg, once daily, 12 weeks
Study Arms / Comparison Groups
  • A1: Active Comparator
    Intervention: Drug: Aripiprazole
  • A2: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE388
Estimated Completion DateFebruary 2011
Estimated Primary Completion DateFebruary 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of Bipolar I mania (YMRS≥16)
  • Treated with lithium or valproate monotherapy for a manic episode and based on the investigator's clinical judgment could benefit from adjunctive treatment with aripiprazole

Exclusion Criteria:

  • Subject with a diagnosis of delirium, dementia, amnestic or other cognitive disorders, or a psychotic disorder
  • Subject with a current diagnosis of Bipolar II Disorder, Bipolar Disorder NOS, or any other primary psychiatric disorder other than Bipolar I Disorder
  • Subject with thyroid pathology
  • Subjects demonstrating cocaine abuse or dependence within the past 3 months prior to screening
  • Subject with a history of neuroleptic malignant syndrome from antipsychotic agents
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
Location Countries  ICMJEAustria,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Italy,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Turkey

Administrative Information

NCT ID  ICMJENCT00665366
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECN138-502, EudraCT number 2007-005959-42
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJEOtsuka America Pharmaceutical
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb