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

NCT ID: NCT01059539

Last Updated: 2019-06-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

403 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-02-29

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.

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Detailed Description

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Conditions

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Bipolar I Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cariprazine

Intervention Type DRUG

Cariprazine was supplied in capsules.

Interventions

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Cariprazine

Cariprazine was supplied in capsules.

Intervention Type DRUG

Other Intervention Names

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RGH-188

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gedeon Richter Ltd.

INDUSTRY

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Diaz, MD

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site 015

Springdale, Arkansas, United States

Site Status

Forest Investigative Site 010

Carson, California, United States

Site Status

Forest Investigative Site 020

Cerritos, California, United States

Site Status

Forest Investigative Site 009

Escondido, California, United States

Site Status

Forest Investigative Site 004

Garden Grove, California, United States

Site Status

Forest Investigative Site 016

San Diego, California, United States

Site Status

Forest Investigative Site 007

Santa Ana, California, United States

Site Status

Forest Investigative Site 023

Washington D.C., District of Columbia, United States

Site Status

Forest Investigative Site 001

Bradenton, Florida, United States

Site Status

Forest Investigative Site 006

Fort Lauderdale, Florida, United States

Site Status

Forest Investigative Site 013

Kissimmee, Florida, United States

Site Status

Forest Investigative Site 021

Rockville, Maryland, United States

Site Status

Forest Investigative Site 024

Flowood, Mississippi, United States

Site Status

Forest Investigative Site 022

Creve Coeur, Missouri, United States

Site Status

Forest Investigative Site 003

Saint Charles, Missouri, United States

Site Status

Forest Investigative Site 025

St Louis, Missouri, United States

Site Status

Forest Investigative Site 012

Las Vegas, Nevada, United States

Site Status

Forest Investigative Site 002

Willingboro, New Jersey, United States

Site Status

Forest Investigative Site 005

Cincinnati, Ohio, United States

Site Status

Forest Investigative Site 011

Oklahoma City, Oklahoma, United States

Site Status

Forest Investigative Site 017

Austin, Texas, United States

Site Status

Forest Investigative Site 014

Austin, Texas, United States

Site Status

Forest Investigative Site 018

DeSoto, Texas, United States

Site Status

Forest Investigative Site 019

Houston, Texas, United States

Site Status

Forest Investigative Site 309

Gyula, Bekes County, Hungary

Site Status

Forest Investigative Site 301

Budapest, , Hungary

Site Status

Forest Investigative Site 302

Budapest, , Hungary

Site Status

Forest Investigative Site 306

Nyíregyháza, , Hungary

Site Status

Forest Investigative Site 308

Szombathely, , Hungary

Site Status

Forest Investigative Site 402

Tuszyn, Kodz, Poland

Site Status

Forest Investigative Site 404

Katowice, Silesian, Poland

Site Status

Forest Investigative Site 407

Gdansk, , Poland

Site Status

Forest Investigative Site 408

Gmina Świecie, , Poland

Site Status

Forest Investigative Site 401

Gorlice, , Poland

Site Status

Forest Investigative Site 505

Barcelona, , Spain

Site Status

Countries

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United States Hungary Poland Spain

References

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Ketter TA, Sachs GS, Durgam S, Lu K, Starace A, Laszlovszky I, Nemeth G. The safety and tolerability of cariprazine in patients with manic or mixed episodes associated with bipolar I disorder: A 16-week open-label study. J Affect Disord. 2018 Jan 1;225:350-356. doi: 10.1016/j.jad.2017.08.040. Epub 2017 Aug 18.

Reference Type DERIVED
PMID: 28843918 (View on PubMed)

Other Identifiers

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RGH-MD-36

Identifier Type: -

Identifier Source: org_study_id

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