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Long-term Study of Cariprazine in Patients With Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104792
First Posted: April 15, 2010
Last Update Posted: April 25, 2014
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
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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Pharmacokinetics: Plasma concentrations of cariprazine and its metabolites [ Time Frame: 48 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT01104792


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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01104792     History of Changes
Other Study ID Numbers: RGH-MD-11
First Submitted: April 12, 2010
First Posted: April 15, 2010
Last Update Posted: April 25, 2014
Last Verified: March 2014

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 Spectrum and Other Psychotic Disorders
Mental Disorders