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
  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:


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
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, see Learn About Clinical Studies.

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 September 22, 2014