FindTrial
Sign In

A multicenter investigative study of the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer for the treatment of patients with bipolar disorder experiencing a manic or mixed episode

A multicenter investigative study of the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer for 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-jRCT2080220516
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. -Patients 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" -Patients with a YMRS total score of 16 or more

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