Safety and Efficacy of Cariprazine in Patients With Schizophrenia

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Cariprazine; Drug: Aripiprazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104766

RGH-MD-04

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Enrollment: 617 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have provided informed consent 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/ or electrocardiogram (ECG)
• Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1
• Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
• CGI-S score ≥ 4

Exclusion criteria

• Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
• Bipolar I and II disorder
• Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
• DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
• Women who are pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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617 participants in 4 patient groups, including a placebo group

Cariprazine 3mg

Experimental group

Description:

Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Treatment:

Drug: Cariprazine

Cariprazine 6mg

Experimental group

Description:

Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Treatment:

Drug: Cariprazine

Aripiprazole 10mg

Active Comparator group

Description:

Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Treatment:

Drug: Aripiprazole

Placebo

Placebo Comparator group

Description:

Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Treatment:

Drug: Placebo