Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Otsuka America Pharmaceutical
Conditions:
Bipolar Disorder Mania
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.
Eligibility Criteria
Inclusion
- Key inclusion criteria:
- Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features
- Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole
- Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline
- Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment.
- Key exclusion criteria:
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product
- A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder
- Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder)
- Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania
- Thyroid pathology
- Demonstrated cocaine abuse or dependence within the past 3 months prior to screening.
- History of neuroleptic malignant syndrome from antipsychotic agents
- Manic symptoms that investigator considers refractory to treatment
- Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms
- Significant risk of suicide based on history, mental status exam, or investigator judgment.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
493 Patients enrolled
Trial Details
Trial ID
NCT00665366
Start Date
June 1 2008
End Date
October 1 2011
Last Update
December 2 2013
Active Locations (73)
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1
Local Institution
Salzburg, Austria, 5020
2
Local Institution
Vienna, Austria, 1090
3
Local Institution
Hradec Králové, Czechia, 500 05
4
Local Institution
Litoměřice, Czechia, 41201