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

Phase 3

Completed

• Conditions: Bipolar I Disorder
• Interventions: Drug: Cariprazine

• Registration Number: NCT01059539
• Lead Sponsor: Forest Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-02-01
• Study Start: 2010-02-28
• Primary Completion: 2012-02-29
• Study Completion: 2012-02-29
• Disposition First Submitted: 2012-12-06
• Disposition First Submitted QC: 2012-12-06
• Disposition First Posted: 2012-12-10
• Status Verified: 2019-05
• Results First Submitted: 2019-05-17
• Results First Submitted QC: 2019-05-17
• Last Update Submitted: 2019-05-17
• Results First Posted: 2019-06-13
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cariprazine 3-12 mg/day for 16 weeks	Cariprazine	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the YMRS Total Score at Week 16	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 Outcome Measures

Name	Time	Method
Change From Baseline in the MADRS Total Score at Week 16	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.

Trial Locations

Locations (35)

Forest Investigative Site 015; 🇺🇸 Springdale, Arkansas, United States

Forest Investigative Site 004; 🇺🇸 Garden Grove, California, United States

Forest Investigative Site 010; 🇺🇸 Carson, California, United States

Forest Investigative Site 020; 🇺🇸 Cerritos, California, United States

Forest Investigative Site 009; 🇺🇸 Escondido, California, United States

Forest Investigative Site 016; 🇺🇸 San Diego, California, United States

Forest Investigative Site 023; 🇺🇸 Washington, District of Columbia, United States

Forest Investigative Site 021; 🇺🇸 Rockville, Maryland, United States

Forest Investigative Site 024; 🇺🇸 Flowood, Mississippi, United States

Forest Investigative Site 003; 🇺🇸 Saint Charles, Missouri, United States

Forest Investigative Site 022; 🇺🇸 Creve Coeur, Missouri, United States

Forest Investigative Site 025; 🇺🇸 Saint Louis, Missouri, United States

Forest Investigative Site 012; 🇺🇸 Las Vegas, Nevada, United States

Forest Investigative Site 011; 🇺🇸 Oklahoma City, Oklahoma, United States

Forest Investigative Site 005; 🇺🇸 Cincinnati, Ohio, United States

Forest Investigative Site 017; 🇺🇸 Austin, Texas, United States

Forest Investigative Site 014; 🇺🇸 Austin, Texas, United States

Forest Investigative Site 018; 🇺🇸 DeSoto, Texas, United States

Forest Investigative Site 309; 🇭🇺 Gyula, Bekes, Hungary

Forest Investigative Site 301; 🇭🇺 Budapest, Hungary

Forest Investigative Site 306; 🇭🇺 Nyiregyhaza, Hungary

Forest Investigative Site 302; 🇭🇺 Budapest, Hungary

Forest Investigative Site 308; 🇭🇺 Szombathely, Hungary

Forest Investigative Site 404; 🇵🇱 Katowice, Silesian, Poland

Forest Investigative Site 402; 🇵🇱 Tuszyn, Kodz, Poland

Forest Investigative Site 407; 🇵🇱 Gdansk, Poland

Forest Investigative Site 401; 🇵🇱 Gorlice, Poland

Forest Investigative Site 505; 🇪🇸 Barcelona, Spain

Forest Investigative Site 408; 🇵🇱 Swiecie, Poland

Forest Investigative Site 007; 🇺🇸 Santa Ana, California, United States

Forest Investigative Site 001; 🇺🇸 Bradenton, Florida, United States

Forest Investigative Site 006; 🇺🇸 Fort Lauderdale, Florida, United States

Forest Investigative Site 013; 🇺🇸 Kissimmee, Florida, United States

Forest Investigative Site 002; 🇺🇸 Willingboro, New Jersey, United States

Forest Investigative Site 019; 🇺🇸 Houston, Texas, United States