A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia

• Status: Completed
• Trial end date: 2014-09-03
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Gedeon Richter Ltd.
• Treatments: Cariprazine

Criteria

Inclusion Criteria:

• Participants who have provided informed consent prior to any study specific procedures.

• Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.

• Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).

• Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).

• Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).

• Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).

• Body mass index between 18 and 40 kg/m^2, inclusive.

Exclusion Criteria:

• Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.

• Participants in their first episode of psychosis.

• Treatment-resistant schizophrenia over the last 2 years.

• Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.

• At imminent risk of injuring self or others or causing significant damage to property.

• Suicide risk.