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

NCT01059539 | Completed Phase 3 Results

• 1 other identifier: RGH-MD-36
• Study Type: interventional
• Target: 403
• Locations: 4 countries
• Sites: 35

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.

Conditions

Bipolar I Disorder

Keywords

Mania; Acute mania; Bipolar I disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in the MADRS Total Score at Week 16

  Baseline to Week 16

Study Arms (1)

Cariprazine 3-12 mg/day for 16 weeks

EXPERIMENTAL

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

Interventions

Cariprazine DRUG

Cariprazine was supplied in capsules.

Also known as: RGH-188

Cariprazine 3-12 mg/day for 16 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.

Sponsors & Collaborators

• Forest Laboratories: lead
• Gedeon Richter Ltd.: collaborator

Study Sites (35)

Forest Investigative Site 015

Springdale, Arkansas, 72764, United States

Location

Forest Investigative Site 010

Carson, California, 90746, United States

Location

Forest Investigative Site 020

Cerritos, California, 90703, United States

Location

Forest Investigative Site 009

Escondido, California, 92025, United States

Location

Forest Investigative Site 004

Garden Grove, California, 92845, United States

Location

Forest Investigative Site 016

San Diego, California, 92102, United States

Location

Forest Investigative Site 007

Santa Ana, California, 92701, United States

Location

Forest Investigative Site 023

Washington D.C., District of Columbia, 20016, United States

Location

Forest Investigative Site 001

Bradenton, Florida, 34208, United States

Location

Forest Investigative Site 006

Fort Lauderdale, Florida, 33308, United States

Location

Forest Investigative Site 013

Kissimmee, Florida, 34741, United States

Location

Forest Investigative Site 021

Rockville, Maryland, 20850, United States

Location

Forest Investigative Site 024

Flowood, Mississippi, 39232, United States

Location

Forest Investigative Site 022

Creve Coeur, Missouri, 63141, United States

Location

Forest Investigative Site 003

Saint Charles, Missouri, 63301, United States

Location

Forest Investigative Site 025

St Louis, Missouri, 63118, United States

Location

Forest Investigative Site 012

Las Vegas, Nevada, 89102, United States

Location

Forest Investigative Site 002

Willingboro, New Jersey, 08046, United States

Location

Forest Investigative Site 005

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site 011

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 017

Austin, Texas, 78731, United States

Location

Forest Investigative Site 014

Austin, Texas, 78754, United States

Location

Forest Investigative Site 018

DeSoto, Texas, 75115, United States

Location

Forest Investigative Site 019

Houston, Texas, 77008, United States

Location

Forest Investigative Site 309

Gyula, Bekes County, 5700, Hungary

Location

Forest Investigative Site 301

Budapest, 1083, Hungary

Location

Forest Investigative Site 302

Budapest, 1135, Hungary

Location

Forest Investigative Site 306

Nyíregyháza, 4400, Hungary

Location

Forest Investigative Site 308

Szombathely, 9700, Hungary

Location

Forest Investigative Site 402

Tuszyn, Kodz, 95-080, Poland

Location

Forest Investigative Site 404

Katowice, Silesian, 40-340, Poland

Location

Forest Investigative Site 407

Gdansk, 80-952, Poland

Location

Forest Investigative Site 408

Gmina Świecie, 86-100, Poland

Location

Forest Investigative Site 401

Gorlice, 38-300, Poland

Location

Forest Investigative Site 505

Barcelona, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 28843918 DERIVED

MeSH Terms

Conditions

Mania

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Willie R. Earley, MD Associate Vice President Clinical Development-CNS
• Organization: Allergan

IR-CTRegistration@allergan.com

714-246-4500

Study Officials

• Elizabeth Diaz, MD

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: February 1, 2010
• Study Start: February 28, 2010
• Primary Completion: February 29, 2012
• Study Completion: February 29, 2012
• Last Updated: June 13, 2019
• Results First Posted: June 13, 2019

Record last verified: 2019-05

Locations

US (24); PL (5); HU (5); ES (1)