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

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)

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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