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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Forest Laboratories

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gedeon Richter Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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