Long-term Study of Cariprazine in Patients With Schizophrenia

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Cariprazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104792

RGH-MD-11

Details and patient eligibility

About

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

Enrollment: 752 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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752 participants in 1 patient group

Cariprazine

Experimental group

Description:

Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.

Treatment:

Drug: Cariprazine