Long-term Study of Cariprazine in Patients With Schizophrenia

July 25, 2019 updated by: Forest Laboratories

Evaluation of the Long-term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

752

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
      • Ahmedabad, India, 380006
        • Forest Investigative Site 503
      • Ahmedabad, India, 380006
        • Forest Investigative Site 519
      • Ahmedabad, India, 380013
        • Forest Investigative Site 501
      • Aurangabad, India, 431005
        • Forest Investigative Site 500
      • Kanpur, India, 208005
        • Forest Investigative Site 507
      • Lucknow, India, 226006
        • Forest Investigative Site 518
      • Mangalore, India, 575001
        • Forest Investigative Site 517
      • Mangalore, India, 575018
        • Forest Investigative Site 515
      • Mumbai, India, 400026
        • Forest Investigative Site 510
      • Nashik, India, 422101
        • Forest Investigative Site 513
      • Rajkot, India, 360002
        • Forest Investigative Site 509
      • Varanasi, India, 201010
        • Forest Investigative Site 506
      • Vijaywada, India, 520002
        • Forest Investigative Site 505
  • Romania
      • Bucuresti, Romania, 41914
        • Forest Investigative Site 306
      • Cluj-Napoca, Romania, 400012
        • Forest Investigative Site 301
      • Craiova, Romania, 200620
        • Forest Investigative Site 300
      • Craiova, Romania, 200745
        • Forest Investigative Site 311
      • Targoviste, Romania, 130086
        • Forest Investigative Site 303
      • Targu Mures, Romania, 540142
        • Forest Investigative Site 304
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163530
        • Forest Investigative Site 102
      • Chelyabinsk, Russian Federation, 454087
        • Forest Investigative Site 103
      • Chita, Russian Federation, 672090
        • Forest Investigative Site 104
      • Saratov, Russian Federation, 410028
        • Forest Investigative Site 110
      • Saratov, Russian Federation, 410060
        • Forest Investigative Site 108
      • St. Petersburg, Russian Federation, 190121
        • Forest Investigative Site 112
      • St. Petersburg, Russian Federation, 192019
        • Forest Investigative Site 105
      • St. Petersburg, Russian Federation, 192019
        • Forest Investigative Site 106
      • St. Petersburg, Russian Federation, 192019
        • Forest Investigative Site 113
      • St. Petersburg, Russian Federation, 193167
        • Forest Investigative Site 107
      • St. Petersburg, Russian Federation, 197341
        • Forest Investigative Site 109
      • Tomsk, Russian Federation, 634014
        • Forest Investigative Site 100
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • Forest Investigative Site 208
      • Dnipropetrovsk, Ukraine, 49027
        • Forest Investigative Site 205
      • Donetsk, Ukraine, 83008
        • Forest Investigative Site 200
      • Kharkiv, Ukraine, 61068
        • Forest Investigative Site 204
      • Kharkov, Ukraine, 61068
        • Forest Investigative Site 203
      • Kyiv, Ukraine, 04080
        • Forest Investigative Site 201
      • Lviv, Ukraine, 79021
        • Forest Investigative Site 202
      • Poltava, Ukraine, 36006
        • Forest Investigative Site 209
      • Simferopol, Ukraine, 95006
        • Forest Investigative Site 210
      • Vinnytsya, Ukraine, 21005
        • Forest Investigative Site 207
    • Kyiv Region
      • Glevakha, Kyiv Region, Ukraine, 08631
        • Forest Investigative Site 211
    • Stepanivka
      • Kherson, Stepanivka, Ukraine, 73488
        • Forest Investigative Site 206
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • Forest Investigative Site 072
      • Little Rock, Arkansas, United States, 72211
        • Forest Investigative Site 021
      • Little Rock, Arkansas, United States, 72211
        • Forest Investigative Site 086
      • Springdale, Arkansas, United States, 72764
        • Forest Investigative Site 014
    • California
      • Carson, California, United States, 90746
        • Forest Investigative Site 080
      • Cerritos, California, United States, 90703
        • Forest Investigative Site 079
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 048
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 070
      • Garden Grove, California, United States, 92845
        • Forest Investigative Site 022
      • Garden Grove, California, United States, 92845
        • Forest Investigative Site 083
      • Long Beach, California, United States, 90813
        • Forest Investigative Site 050
      • Oceanside, California, United States, 92056
        • Forest Investigative Site 006
      • Riverside, California, United States, 92506
        • Forest Investigative Site 003
      • San Diego, California, United States, 92123
        • Forest Investigative Site 016
      • Santa Ana, California, United States, 92701
        • Forest Investigative Site 073
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • Forest Investigative Site 071
    • Florida
      • Bradenton, Florida, United States, 34208
        • Forest Investigative Site 002
      • Kissimmee, Florida, United States, 34741
        • Forest Investigative Site 041
      • North Miami, Florida, United States, 33161
        • Forest Investigative Site 082
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Forest Investigative Site 055
      • Atlanta, Georgia, United States, 30308
        • Forest Investigative Site 087
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Forest Investigative Site 012
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Forest Investigative Site 018
      • Hoffman Estates, Illinois, United States, 60169
        • Forest Investigative Site 008
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Forest Investigative Site 044
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Forest Investigative Site 007
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Forest Investigative Site 017
      • Saint Charles, Missouri, United States, 63301
        • Forest Investigative Site 076
      • Saint Louis, Missouri, United States, 63118
        • Forest Investigative Site 045
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Forest Investigative Site 052
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • Forest Investigative Site 004
    • New York
      • Cedarhurst, New York, United States, 11516
        • Forest Investigative Site 040
    • Ohio
      • Willoughby, Ohio, United States, 44094
        • Forest Investigative Site 019
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19131
        • Forest Investigative Site 077
      • Philadelphia, Pennsylvania, United States, 19139
        • Forest Investigative Site 047
    • Texas
      • Austin, Texas, United States, 78756
        • Forest Investigative Site 074
      • DeSoto, Texas, United States, 75115
        • Forest Investigative Site 084
      • Irving, Texas, United States, 75062
        • Forest Investigative Site 043
    • Washington
      • Bellevue, Washington, United States, 98007
        • Forest Investigative Site 078

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 and corresponding caregivers who have provided informed consents 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).
  • Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cariprazine
Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
Drug: Cariprazine
Cariprazine was supplied in capsules.
Other Names:
  • RGH-188

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 48 in the PANSS Total Score
Time Frame: Baseline to Week 48
The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.
Baseline to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 48 in the CGI-S Score
Time Frame: Baseline to Week 48
The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.
Baseline to Week 48

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)

May 31, 2010

Primary Completion (Actual)

January 31, 2013

Study Completion (Actual)

January 31, 2013

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-11

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.

Clinical Trials on Schizophrenia

Clinical Trials on Cariprazine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe