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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000202-49-EE
Enrollment
575
Registered
2005-02-22
Start date
2005-02-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder

Interventions

Trade Name: Depakote 250 Product Name: Depakote 250 Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Valproate semisodium Concentration unit: mg milligram(s) Concentration type: equal

Sponsors

Bristol-Myers Squibb International Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Estonia, Hungary, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026