Safety and Efficacy of Cariprazine in Schizophrenia

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Cariprazine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104779

RGH-MD-05

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: 446 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)
• Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
• Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
• Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion criteria

• Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
• Patients in their first episode of psychosis
• Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
• Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
• Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
• Substance abuse or dependence within the prior 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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446 participants in 3 patient groups, including a placebo group

Cariprazine (3-6 mg/day)

Experimental group

Description:

Cariprazine once daily fixed-flexible low dose

Treatment:

Drug: Cariprazine

Cariprazine (6-9 mg/day)

Experimental group

Description:

Cariprazine once daily fixed-flexible high dose

Treatment:

Drug: Cariprazine

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo