Long-term Study of Cariprazine in Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01104792
First received: April 12, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The objective of this study is to evaluate the long-term safety, tolerability and pharmacokinetics of cariprazine in patients with schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: Cariprazine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Long-Term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Safety: adverse event recording, clinical laboratory parameters, vital signs, electrocardiograms and other [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Plasma concentrations of cariprazine and its metabolites [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 588
Study Start Date: April 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cariprazine flexible dose, oral administration once daily for 48 weeks
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.
Other Name: RGH-188

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients and corresponding caregivers who have provided informed consents prior to any study specific procedures
  • Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
  • Patients with normal physical examination, laboratory, vital signs and electrocardiogram (ECG)

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.
  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: NCT01104792

  Show 86 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Raffaele Migliore, MA Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01104792     History of Changes
Other Study ID Numbers: RGH-MD-11
Study First Received: April 12, 2010
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
Colombia: National Institutes of Health
South Africa: Department of Health
Ukraine: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Forest Laboratories:
Schizophrenia
Acute Schizophrenia
Psychotropic Drugs
Antipsychotic Agents
Mental Disorders
Dopamine Agents
Central Nervous System Agents

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

ClinicalTrials.gov processed this record on September 22, 2014