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

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

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

Conditions
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Bipolar I Disorder

Intervention / Treatment
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* Drug: Cariprazine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cariprazine 3-12 mg/day for 16 weeks<br>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. | Drug: Cariprazine<br>* Cariprazine was supplied in capsules.<br>* Other names: RGH-188;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the YMRS Total Score at 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. | Baseline to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the MADRS Total Score at 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. | Baseline to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mania, Acute mania, Bipolar I disorder