Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

May 17, 2019 updated by: Forest Laboratories

Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia

This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

732

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
      • Johor Bahru, Johor, Malaysia, 80100
        • Forest Investigative Site
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Forest Investigative Site
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Forest Investigative Site
    • Perak
      • Ipoh, Perak, Malaysia, 30990
        • Forest Investigative Site
      • Ulu Kinta, Perak, Malaysia, 31250
        • Forest Investigative Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163060
        • Forest Investigative Site
      • Gatchina, Russian Federation, 188357
        • Forest Investigative Site
      • Kazan, Russian Federation, 420012
        • Forest Investigative Site
      • Moscow, Russian Federation, 117152
        • Forest Investigative Site
      • Moscow, Russian Federation, 115522
        • Forest Investigative Site 1
      • Moscow, Russian Federation, 115522
        • Forest Investigative Site 2
      • Nizhniy Novgorod, Russian Federation, 603155
        • Forest Investigative Site
      • Samara, Russian Federation, 443016
        • Forest Investigative Site
      • St. Petersburg, Russian Federation, 190121
        • Forest Investigative Site
      • St. Petersburg, Russian Federation, 191119
        • Forest Investigative Site
      • St. Petersburg, Russian Federation, 193167
        • Forest Investigative Site
      • St. Petersburg, Russian Federation, 197341
        • Forest Investigative Site
      • St. Petersburg, Russian Federation, 190005
        • Forest Investigative Site
      • St. Petersburg, Russian Federation, 193019
        • Forest Investigative Site 2
      • St. Petersburg, Russian Federation, 193019
        • Forest Investigative Site1
  • Ukraine
      • Chernigiv, Ukraine, 14000
        • Forest Investigative Site
      • Kherson, Vil. Stepanivka, Ukraine, 73488
        • Forest Investigative Site
      • Kiev, Ukraine, 02660
        • Forest Investigative Site
    • Dnipropetrovsk Oblast
      • Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine, 49616
        • Forest Investigative Site
    • Donetsk Oblast
      • Donetsk, Donetsk Oblast, Ukraine, 83037
        • Forest Investigative Site
    • Kharkiv Oblast
      • Kharkiv, Kharkiv Oblast, Ukraine, 61068
        • Forest Investigative Site
    • Kyiv Oblast
      • Glevakha, Kyiv Oblast, Ukraine, 08630
        • Forest Investigative Site
      • Kyiv, Kyiv Oblast, Ukraine, 04080
        • Forest Investigative Site
      • Kyiv, Kyiv Oblast, Ukraine, 04655
        • Forest Investigative Site
    • Odessa Oblast
      • Odessa, Odessa Oblast, Ukraine, 65006
        • Forest Investigative Site
    • Ternopil Oblast
      • Ternopil, Ternopil Oblast, Ukraine, 46020
        • 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
      • Bridgeton, Missouri, United States, 63044
        • Forest Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Forest Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29405
        • Forest Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 28117
        • Forest Investigative Site
    • Texas
      • Houston, Texas, United States, 77008
        • Forest Investigative Site
      • Houston, Texas, United States, 77021
        • 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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, 18 to 60 years of age.
  • Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
  • Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
  • Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

  • Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
  • First episode of psychosis.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received placebo orally once a day for 6 weeks.
Drug: Placebo
Placebo was supplied in capsules.
Experimental: Cariprazine 1.5 mg
Participants received cariprazine 1.5 mg orally once a day for 6 weeks.
Drug: Cariprazine
Cariprazine was supplied in capsules
Other Names:
  • RGH-188
Experimental: Cariprazine 3.0 mg
Participants received cariprazine 3.0 mg orally once a day for 6 weeks.
Drug: Cariprazine
Cariprazine was supplied in capsules
Other Names:
  • RGH-188
Experimental: Cariprazine 4.5 mg
Participants received cariprazine 4.5 mg orally once a day for 6 weeks.
Drug: Cariprazine
Cariprazine was supplied in capsules
Other Names:
  • RGH-188
Active Comparator: Risperidone 4.0 mg
Participants received risperidone 4.0 mg orally once a day for 6 weeks.
Drug: Risperidone
Risperidone was supplied in capsules
Other Names:
  • Risperdal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 6 in the PANSS Total Score
Time Frame: Baseline to Week 6
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 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 6 in the CGI-S Score
Time Frame: Baseline to Week 6
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 6

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 Laboratories

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)

June 30, 2008

Primary Completion (Actual)

August 31, 2009

Study Completion (Actual)

August 31, 2009

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

June 9, 2008

First Posted (Estimate)

June 10, 2008

Study Record Updates

Last Update Posted (Actual)

June 12, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-16

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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