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A multicenter, placebo-controlled, double-blind, investigative extension trial of the safety and efficacy of aripiprazole in the treatment of patients with bipolar disorder experiencing a manic or mixed episode

A multicenter, placebo-controlled, double-blind, investigative extension trial of the safety and efficacy of aripiprazole in the treatment of patients with bipolar disorder experiencing a manic or mixed episode

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220514
Enrollment
Unknown
Registered
2008-02-01
Start date
2008-02-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Acute manic and mixed episodes associated with Bipolar I Disorder

Interventions

investigational material(s) Generic name etc : Aripiprazole INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational materia

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial. -Subjects who meet DSM-IV-TR criteria for manic or mixed episodes and have been diagnosed as having "296.4x Bipolar I Disorder in which the most recent episode was manic" or "296.6x Bipolar I Disorder in which the most recent episode was mixed" -Subjects who were enrolled in and have completed Study 003 and who meet the following criteria for demonstration of drug efficacy Subjects demonstrating drug efficacy: Those subjects who completed Study 003 whose score for CGI-BP Change From Preceding Phase (mania) at the time of evaluation on Day 21 of Study 003 (completion) was between 1 (Very much improved) and 3 (Minimally improved)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Safety and Efficacy—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026