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

Bipolar I Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059539
• Other study ID #: RGH-MD-36
• Status: Completed
• Phase: Phase 3
• Start date: February 28, 2010
• Est. completion date: February 29, 2012

Study information

• Verified date: May 2019
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: February 29, 2012
• Est. primary completion date: February 29, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar I Disorder
• Disease

Intervention

Drug:
• Cariprazine
Cariprazine was supplied in capsules.

Locations

Country	Name	City	State
Hungary	Forest Investigative Site 301	Budapest
Hungary	Forest Investigative Site 302	Budapest
Hungary	Forest Investigative Site 309	Gyula	Bekes
Hungary	Forest Investigative Site 306	Nyiregyhaza
Hungary	Forest Investigative Site 308	Szombathely
Poland	Forest Investigative Site 407	Gdansk
Poland	Forest Investigative Site 401	Gorlice
Poland	Forest Investigative Site 404	Katowice	Silesian
Poland	Forest Investigative Site 408	Swiecie
Poland	Forest Investigative Site 402	Tuszyn	Kodz
Spain	Forest Investigative Site 505	Barcelona
United States	Forest Investigative Site 014	Austin	Texas
United States	Forest Investigative Site 017	Austin	Texas
United States	Forest Investigative Site 001	Bradenton	Florida
United States	Forest Investigative Site 010	Carson	California
United States	Forest Investigative Site 020	Cerritos	California
United States	Forest Investigative Site 005	Cincinnati	Ohio
United States	Forest Investigative Site 022	Creve Coeur	Missouri
United States	Forest Investigative Site 018	DeSoto	Texas
United States	Forest Investigative Site 009	Escondido	California
United States	Forest Investigative Site 024	Flowood	Mississippi
United States	Forest Investigative Site 006	Fort Lauderdale	Florida
United States	Forest Investigative Site 004	Garden Grove	California
United States	Forest Investigative Site 019	Houston	Texas
United States	Forest Investigative Site 013	Kissimmee	Florida
United States	Forest Investigative Site 012	Las Vegas	Nevada
United States	Forest Investigative Site 011	Oklahoma City	Oklahoma
United States	Forest Investigative Site 021	Rockville	Maryland
United States	Forest Investigative Site 003	Saint Charles	Missouri
United States	Forest Investigative Site 025	Saint Louis	Missouri
United States	Forest Investigative Site 016	San Diego	California
United States	Forest Investigative Site 007	Santa Ana	California
United States	Forest Investigative Site 015	Springdale	Arkansas
United States	Forest Investigative Site 023	Washington	District of Columbia
United States	Forest Investigative Site 002	Willingboro	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Gedeon Richter Ltd.

Countries where clinical trial is conducted

United States,  Hungary,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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