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The Purpose of the Study is to Determine Whether Cariprazine is a Safe and Tolerated Long-term Treatment in Patients With Chronic Stable Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00839852
First received: February 5, 2009
Last updated: September 13, 2011
Last verified: September 2011
History of Changes
  Purpose

This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with Schizophrenia.


Condition Intervention Phase
Schizophrenia
 Drug: Cariprazine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Clinical laboratory [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiogram [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Physical Examinations [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Extrapyramidal symtomatology [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: May 2009
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cariprazine
    Patients who meet eligibility criteria will receive open-label cariprazine.
  Eligibility

Ages Eligible for Study:   18 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have completed the double-blind treatment period of the lead-in study (RGH-MD-16)
  • Patients who have responded to double-blind treatment in the lead-in study as outpatients (at least 20% reduction relative to Visit 2 in the lead-in study in PANSS total score and a CGI-S of less than or equal to 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 ECG
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839852

  Show 65 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Suresh Durgam, MD Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00839852     History of Changes
Other Study ID Numbers: RGH-MD-17
Study First Received: February 5, 2009
Last Updated: September 13, 2011
Health Authority: United States: Food and Drug Administration
India: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Malaysia: Ministry of Health
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013