Efficacy of Aripiprazole in Combination with Valproate or Lithium in the Treatment of Mania in Patients with Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy Revised Protocol Number 03, incorporating Amendments 2, 3 and 5+ Pharmacogenetics Blood Sample Amendment 1

Conditions: Bipolar disorder

Registration Number: EUCTR2004-000202-49-EE

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 575

Inclusion Criteria

- Patients with Bipolar I Disorder, manic or mixed episode, with or without psychotic features, as defined by DSM-IV-TR and confirmed by the M.I.N.I. who are partially nonresponsive to lithium or valproate monotherapy;
- Patients who have a history of at least one previous manic or mixed episode of sufficient severity to require hospitalization, and/or treatment with a mood stabilizer or antipsychotic agent;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients presenting clinically with a current DSM-IV -TR diagnosis of :delirium, dementia, amnesia, amnestic or other cognitive disorders, or a psychotic disorder(e.g. schizoprenia or schizoaffective disorder). Also patients with borderline, paranoid, histronis, schizotypal, schzoid or antisocial personality disorder.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of aripiprazole with placebo in combination with lithium or valproate to lithium or valproate monotherapy, as measured by the Y-MRS, in the treatment of Bipolar I Disorder patients with a manic or mixed episode, with or without psychotic features, partially nonresponsive to lithium or valproate monotherapy.;Secondary Objective: To evaluate the safety and tolerability of aripiprazole in combination with lithium or valproate in this same patient population.;Primary end point(s): The primary efficacy measure will be the mean change from baseline to endpoint (Week 6 LOCF) in Y-MRS Total score.

Secondary Outcome Measures