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
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Keep this study
Lead
Otsuka Pharmaceutical Development & Commercialization, Inc.
With
Otsuka America Pharmaceutical
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
