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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:
ClinicalTrials.gov Identifier:
NCT00839852
First Posted: February 10, 2009
Last Update Posted: September 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Forest Laboratories:

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00839852     History of Changes
Other Study ID Numbers: RGH-MD-17
First Submitted: February 5, 2009
First Posted: February 10, 2009
Last Update Posted: September 21, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders