A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia

June 5, 2018 updated by: Forest Laboratories

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia

The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There were 3 periods (phases) in the study. The Open-label Phase lasted 20 weeks. In the first 6 weeks, participants received 3, 6, or 9 mg cariprazine orally once a day; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this Open-label Phase. At the end of Week 8, participants had to meet the following criteria to continue in the study.

  • Positive and Negative Syndrome Scale (PANSS) total score ≤ 60 at the end of Week 8
  • At least 20% decrease in PANSS total score from baseline to the end of Week 8
  • Clinical Global Impressions - Severity (CGI-S) score ≤ 4 at the end of Week 8
  • Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 8
  • Stable dose during the previous 2 weeks
  • No significant tolerability issues as judged by the Investigator at the end of Week 8

At the end of the Open-label Phase, participants were randomized into 2 treatment groups, cariprazine or placebo, if they met the following criteria:

  • PANSS total score ≤ 60 at the end of Week 20
  • At least 20% decrease in PANSS total score from baseline to the end of Week 20
  • CGI-S score ≤ 4 at the end of Week 20
  • Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 20
  • No significant tolerability issues as judged by the Investigator During this Double-blind Treatment Phase, participants received either placebo or cariprazine at the same dosage (3, 6, or 9 mg) that they received during the last 14 weeks of the Open-label Phase.

All participants entered the 4 week Safety Follow-up Phase. They received a treatment other than the investigational product at the discretion of the Investigator.

Study Type

Interventional

Enrollment (Actual)

765

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • Forest Investigative Site 305
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Forest Investigative Site 303
      • Ahmedabad, Gujarat, India, 380006
        • Forest Investigative Site 308
      • Ahmedabad, Gujarat, India, 380015
        • Forest Investigative Site 310
    • Karnataka
      • Mangalore, Karnataka, India, 575018
        • Forest Investigative Site 313
      • Manipal, Karnataka, India, 576104
        • Forest Investigative Site 314
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431005
        • Forest Investigative Site 301
      • Kalyan, Maharashtra, India, 421301
        • Forest Investigative Site 306
      • Nashik, Maharashtra, India, 422101
        • Forest Investigative Site 311
    • Rajasthan
      • Jaipur, Rajasthan, India, 302021
        • Forest Investigative Site 317
      • Jaipur, Rajasthan, India, 303706
        • Forest Investigative Site 302
    • Tamilnadu
      • Madurai, Tamilnadu, India, 625020
        • Forest Investigative Site 312
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208005
        • Forest Investigative Site 309
      • Lucknow, Uttar Pradesh, India, 226003
        • Forest Investigative Site 304
      • Varanasi, Uttar Pradesh, India, 221005
        • Forest Investigative Site 307
  • Romania
      • Bucuresti, Romania, 041914
        • Forest Investigative Site 403
      • Bucuresti, Romania, 041914
        • Forest Investigative Site 405
      • Bucuresti, Romania, 041914
        • Forest Investigative Site 406
      • Bucuresti, Romania, 041914
        • Forest Investigative Site 408
      • Bucuresti, Romania, 041914
        • Forest Investigative Site 410
      • Campulung, Romania, 115100
        • Forest Investigative Site 407
      • Campulung, Romania, 115100
        • Forest Investigative Site 412
      • Constanta, Romania, 900002
        • Forest Investigative Site 402
      • Focsani, Romania, 620165
        • Forest Investigative Site 411
      • Iasi, Romania, 700282
        • Forest Investigative Site 401
      • Iasi, Romania, 700282
        • Forest Investigative Site 409
      • Targoviste, Romania, 130086
        • Forest Investigative Site 404
  • Slovakia
      • Bratislava, Slovakia, 81369
        • Forest Investigative Site 508
      • Bratislava, Slovakia, 82606
        • Forest Investigative Site 507
      • Liptovsky Mikulas, Slovakia, 03125
        • Forest Investigative Site 504
      • Rimavska Sobota, Slovakia, 97912
        • Forest Investigative Site 505
      • Roznava, Slovakia, 04801
        • Forest Investigative Site 503
      • Trnava, Slovakia, 91701
        • Forest Investigative Site 506
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49115
        • Forest Investigative Site 610
      • Donetsk, Ukraine, 83008
        • Forest Investigative Site 613
      • Ivano-Frankivsk, Ukraine, 76014
        • Forest Investigative Site 616
      • Kharkiv, Ukraine, 61068
        • Forest Investigative Site 605
      • Kharkiv, Ukraine, 61068
        • Forest Investigative Site 606
      • Kharkiv, Ukraine, 61103
        • Forest Investigative Site 604
      • Kherson, Ukraine, 73488
        • Forest Investigative Site 607
      • Kyiv, Ukraine, 02660
        • Forest Investigative Site 602
      • Kyiv, Ukraine, 04080
        • Forest Investigative Site 601
      • Kyiv, Ukraine, 04080
        • Forest Investigative Site 612
      • Lviv, Ukraine, 79021
        • Forest Investigative Site 603
      • Odesa, Ukraine, 65014
        • Forest Investigative Site 615
      • Simferopol, Ukraine, 95006
        • Forest Investigative Site 611
      • Vinnytsia, Ukraine, 21005
        • Forest Investigative Site 608
    • AR Crimea
      • Kerch, AR Crimea, Ukraine, 98310
        • Forest Investigative Site 609
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Forest Investigative Site 011
    • California
      • Cerritos, California, United States, 90703
        • Forest Investigative Site 018
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 007
      • Culver City, California, United States, 90230
        • Forest Investigative Site 026
      • Long Beach, California, United States, 90813
        • Forest Investigative Site 008
      • Oceanside, California, United States, 92056
        • Forest Investigative Site 002
      • Orange, California, United States, 92868
        • Forest Investigative Site 019
      • Paramount, California, United States, 90723
        • Forest Investigative Site 001
      • San Diego, California, United States, 92123
        • Forest Investigative Site 020
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Forest Investigative Site 005
    • Florida
      • Leesburg, Florida, United States, 34748
        • Forest Investigative Site 024
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Forest Investigative Site 017
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Forest Investigative Site 021
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Forest Investigative Site 023
      • Rockville, Maryland, United States, 20850
        • Forest Investigative Site 010
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Forest Investigative Site 003
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Forest Investigative Site 006
      • Saint Louis, Missouri, United States, 63141
        • Forest Investigative Site 014
    • New York
      • Cedarhurst, New York, United States, 11516
        • Forest Investigative Site 012
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Forest Investigative Site 022
    • Texas
      • Austin, Texas, United States, 78731
        • Forest Investigative Site 015
      • Austin, Texas, United States, 78754
        • Forest Investigative Site 027
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site 025
      • Houston, Texas, United States, 77008
        • Forest Investigative Site 013
      • Houston, Texas, United States, 77021
        • Forest Investigative Site 009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants who have provided informed consent prior to any study specific procedures.
  • Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.
  • Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
  • Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
  • Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
  • Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
  • Body mass index between 18 and 40 kg/m^2, inclusive.

Exclusion Criteria:

  • Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
  • Participants in their first episode of psychosis.
  • Treatment-resistant schizophrenia over the last 2 years.
  • Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
  • At imminent risk of injuring self or others or causing significant damage to property.
  • Suicide risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cariprazine - Open-label Phase
Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
Drug: Cariprazine
Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
Other Names:
  • RGH-188
Experimental: Placebo - Double-blind Treatment Phase
Participants received placebo orally once a day for 26 to 72 weeks.
Drug: Placebo
Placebo was supplied in capsules.
Experimental: Cariprazine - Double-blind Treatment Phase
Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks
Drug: Cariprazine
Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
Other Names:
  • RGH-188

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Baseline to the First Symptom Relapse During the Double-blind Phase
Time Frame: Up to 34 Weeks and Bi-Weekly thereafter until Week 92

Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored <50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of >4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not performed based on Investigator discretion.

PANSS is 30-item rating scale. Each item scored on 7-point scale. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms. CGI-S is 7-point scale,measures severity of participant's illness in comparison with others with same diagnosis. Lower score indicates less severe illness. 25th percentile for time to relapse was reported.
Up to 34 Weeks and Bi-Weekly thereafter until Week 92

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

Gedeon Richter Ltd.

Investigators

  • Study Director: Willie Earley, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2011

Primary Completion (Actual)

September 3, 2014

Study Completion (Actual)

September 3, 2014

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-06
  • 2011-002048-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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