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Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

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Forest Laboratories

Status and phase

Completed
Phase 3

Conditions

Bipolar I Disorder

Treatments

Drug: Cariprazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01059539
RGH-MD-36

Details and patient eligibility

About

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.

Enrollment

403 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who have provided informed consent prior to any study specific procedures.
  • Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
  • Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
  • Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion criteria

  • Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

403 participants in 1 patient group

Cariprazine 3-12 mg/day for 16 weeks
Experimental group
Description:
Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.
Treatment:
Drug: Cariprazine

Trial contacts and locations

35

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Data sourced from clinicaltrials.gov

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