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

Overview

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

Full Title of Study: “A Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 29, 2012

Interventions

  • Drug: Cariprazine
    • Cariprazine was supplied in capsules.

Arms, Groups and Cohorts

  • Experimental: Cariprazine 3-12 mg/day for 16 weeks
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in the YMRS Total Score at Week 16
    • Time Frame: Baseline to Week 16
    • The Young Mania Rating Scale (YMRS) is an 11-item scale that assesses manic symptoms based on the patient’s perception of his or her condition over the previous 48 hours, as well as the physician’s clinical observations during the interview. The 11 items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of each item is rated on a 5-point (0-4) or a 9-point (0-8) scale. The total score of all 11 items can range from 0 to 60. A higher score indicates worse manic symptoms. A negative change score indicates improvement.

Secondary Measures

  • Change From Baseline in the MADRS Total Score at Week 16
    • Time Frame: Baseline to Week 16
    • The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated scale that evaluates the patient’s depressive symptomatology during the previous week. Patients are rated on 10 items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point (0-6) scale. The total score can range from 0 to 42. A higher score indicates greater depressive symptomatology. A negative change score indicates improvement.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Forest Laboratories
  • Collaborator
    • Gedeon Richter Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elizabeth Diaz, MD, Study Director, Forest Laboratories

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