Overview

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

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator:
Otsuka America Pharmaceutical
Treatments:
Aripiprazole
Lithium Carbonate
Valproic Acid
Criteria
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.