A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

August 8, 2019 updated by: Forest Laboratories

A Long-term, Open-label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients With Schizophrenia

This is an outpatient study 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)

97

Phase

  • Phase 2

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
    • Andh Prad
      • Vijaywada, Andh Prad, India, 520002
        • Forest Investigative Site
      • Visakhapatnam, Andh Prad, India, 530017
        • Forest Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380013
        • Forest Investigative Site
      • Ahmedabad, Gujarat, India, 380015
        • Forest Investigative Site
    • Karna
      • Bangalore, Karna, India, 560010
        • Forest Investigative Site
      • Bangalore, Karna, India, 560027
        • Forest Investigative Site
      • Mangalore, Karna, India, 574160
        • Forest Investigative Site
      • Mangalore, Karna, India, 575001
        • Forest Investigative Site
      • Manipal, Karna, India, 576104
        • Forest Investigative Site
      • Mysore, Karna, India, 570004
        • Forest Investigative Site
    • Mahara
      • Pune, Mahara, India, 411004
        • Forest Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302021
        • Forest Investigative Site
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600003
        • Forest Investigative Site
      • Chennai, Tamilnadu, India, 600101
        • Forest Investigative Site
      • Tirupati, Tamilnadu, India, 517507
        • Forest Investigative Site
    • Uttar Prad
      • Kanpur, Uttar Prad, India, 208005
        • Forest Investigative Site
  • Malaysia
      • Johor Bahru, Malaysia, 80100
        • Forest Investigative Site
      • Kuala Lumpur, Malaysia, 59100
        • Forest Investigative Site
      • Perak, Malaysia, 30990
        • Forest Investigative Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163060
        • Forest Investigative Site
      • Gatchina, Russian Federation, 188357
        • Forest Investigative Site
      • Ivanovo, Russian Federation, 153462
        • Forest Investigative Site
      • Kazan, Russian Federation, 420012
        • Forest Investigative Site
      • Krasnodar, Russian Federation, 350007
        • Forest Investigative Site
      • Moscow, Russian Federation, 115522
        • Forest Investigative Site 204
      • Moscow, Russian Federation, 115522
        • Forest Investigative Site 206
      • Moscow, Russian Federation, 117152
        • Forest Investigative Site
      • Nizhniy Novgorod, Russian Federation, 603155
        • Forest Investigative Site
      • Samara, Russian Federation, 443016
        • Forest Investigative Site
      • St. Petersburg, Russian Federation, 190005
        • Forest Investigative Site 214
      • St. Petersburg, Russian Federation, 190005
        • Forest Investigative Site 217
      • St. Petersburg, Russian Federation, 190121
        • Forest Investigative Site
      • St. Petersburg, Russian Federation, 191119
        • Forest Investigative Site
      • St. Petersburg, Russian Federation, 193019
        • Forest Investigative Site 202
      • St. Petersburg, Russian Federation, 193019
        • Forest Investigative Site 203
      • St. Petersburg, Russian Federation, 193167
        • Forest Investigative Site
      • St. Petersburg, Russian Federation, 197341
        • Forest Investigative Site
  • Ukraine
      • Chernigov, Ukraine, 14000
        • Forest Investigative Site
      • Dnipropetrovsk, Ukraine, 49616
        • Forest Investigative Site
      • Donetsk, Ukraine, 83037
        • Forest Investigative Site
      • Glevakha, Ukraine, 8630
        • Forest Investigative Site
      • Kharkiv, Ukraine, 61068
        • Forest Investivative Site
      • Kiev, Ukraine, 2660
        • Forest Investigative Site
      • Kyiv, Ukraine, 4080
        • Forest Investigative Site
      • Kyiv, Ukraine, 4655
        • Forest Investigative Site
      • Odessa, Ukraine, 65006
        • Forest Investigative Site
      • Ternopil, Ukraine, 46020
        • Forest Investigative Site
    • Vil. Stepanivka
      • Kherson, Vil. Stepanivka, Ukraine, 73488
        • Forest Investigative Site
  • United States
    • California
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site
      • Long Beach, California, United States, 90813
        • Forest Investigative Site
      • Oceanside, California, United States, 92056
        • Forest Investigative Site
      • Paramount, California, United States, 90723
        • Forest Investigative Site
      • Riverside, California, United States, 92506
        • Forest Investigative Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Forest Investigative Site
    • Florida
      • Bradenton, Florida, United States, 34208
        • Forest Investigative Site
      • Kissimmee, Florida, United States, 34741
        • Forest Investigative Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Forest Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Forest Investigative Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Forest Investigative Site
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Forest Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Forest Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29405
        • Forest Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site
    • Texas
      • Houston, Texas, United States, 77008
        • Forest Investigative Site
      • Irving, Texas, United States, 75062
        • Forest Investigative Site

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 61 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have completed the double-blind treatment period of the lead-in study RGH-MD-16 (NCT 00694707)
  • Patients who have responded to double-blind treatment in the lead-in study as defined as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S) score of ≤ 3.
  • Patients eligible to continue as outpatients based on the opinion of the Principal Investigator.
  • Patients must have a caregiver to ensure treatment compliance.

Exclusion Criteria:

  • Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).

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 1.5mg
Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
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.

Investigators

  • Study Director: Suresh Durgam, MD, Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

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, 2009

Primary Completion (Actual)

August 31, 2010

Study Completion (Actual)

August 31, 2010

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-17

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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