Safety and Efficacy of Cariprazine in Schizophrenia

October 18, 2018 updated by: Forest Laboratories

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

446

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

  • Colombia
      • Bogota, Colombia, 110121
        • Forest Investigative Site 602
      • Bogota, Colombia, 111166
        • Forest Investigative Site 605
    • Antioquia
      • Bello, Antioquia, Colombia, 051053
        • Forest Investigative Site 601
    • Risaralda
      • Pereira, Risaralda, Colombia, 660003
        • Forest Investigative Site 604
  • India
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520002
        • Forest Investigative Site 505
      • Visakhapatnam, Andhra Pradesh, India, 530017
        • Forest Investigative Site 514
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Forest Investigative Site 503
      • Ahmedabad, Gujarat, India, 380006
        • Forest Investigative Site 519
      • Ahmedabad, Gujarat, India, 380013
        • Forest Investigative Site 501
      • Ahmedabad, Gujarat, India, 380015
        • Forest Investigative Site 508
    • Karna
      • Bangalore, Karna, India, 560010
        • Forest Investigative Site 504
      • Mangalore, Karna, India, 575001
        • Forest Investigative Site 517
      • Mangalore, Karna, India, 575018
        • Forest Investigative Site 515
      • Mysore, Karna, India, 570015
        • Forest Investigative Site 516
    • Mahara
      • Aurangabad, Mahara, India, 431005
        • Forest Investigative Site 500
      • Mumbai, Mahara, India, 400026
        • Forest Investigative Site 510
      • Nashik, Mahara, India, 422101
        • Forest Investigative Site 513
      • Pune, Mahara, India, 411001
        • Forest Investigative Site 511
      • Pune, Mahara, India, 411030
        • Forest Investigative Site 502
    • Rajastan
      • Rajkot, Rajastan, India, 360002
        • Forest Investigative Site 509
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208005
        • Forest Investigative Site 507
      • Lucknow, Uttar Pradesh, India, 226006
        • Forest Investigative Site 518
      • Varanasi, Uttar Pradesh, India, 201010
        • Forest Investigative Site 506
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2198
        • Forest Investigative Site 704
    • W Cape
      • Cape Town, W Cape, South Africa, 7530
        • Forest Investigative Site 703
      • Cape Town, W Cape, South Africa, 7535
        • Forest Investigative Site 706
  • United States
    • California
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 48
      • Long Beach, California, United States, 90813
        • Forest Investigative Site 50
      • Paramount, California, United States, 90723
        • Forest Investigative Site 42
      • San Diego, California, United States, 92102
        • Forest Investigative Site 054
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Forest Investigative Site 41
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Forest Investigative Site 055
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Forest Investigative Site 44
    • Missouri
      • Saint Louis, Missouri, United States, 63118
        • Forest Investigative Site 45
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Forest Investigative Site 52
    • New York
      • Cedarhurst, New York, United States, 11516
        • Forest Investigative Site 40
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Forest Investigative Site 46
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Forest Investigative Site 47
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative 49
    • Texas
      • Houston, Texas, United States, 77021
        • Forest Investigative Site 51
      • Irving, Texas, United States, 75062
        • Forest Investigative Site 43

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:

  • 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 schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
  • Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
  • Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
  • Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
  • Patients in their first episode of psychosis
  • Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
  • Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
  • Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
  • Substance abuse or dependence within the prior 3 months

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Experimental: Cariprazine (3-6 mg/day)
Cariprazine once daily fixed-flexible low dose
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Other Names:
  • RGH-188
Experimental: Cariprazine (6-9 mg/day)
Cariprazine once daily fixed-flexible high dose
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Other Names:
  • RGH-188

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Baseline to Week 6
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement.
Baseline to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
Time Frame: Baseline to Week 6
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.
Baseline to Week 6

Collaborators and Investigators

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

Sponsor

Forest Laboratories

Collaborators

Gedeon Richter Ltd.

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)

April 27, 2010

Primary Completion (Actual)

December 15, 2011

Study Completion (Actual)

December 15, 2011

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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