Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Risperidone; Drug: Cariprazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00694707

RGH-MD-16

Details and patient eligibility

About

This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Enrollment: 732 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 to 60 years of age.
• Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
• Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
• Diagnosis of schizophrenia for at least 1 year.

Exclusion criteria

• Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
• First episode of psychosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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732 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo orally once a day for 6 weeks.

Treatment:

Drug: Placebo

Cariprazine 1.5 mg

Experimental group

Description:

Participants received cariprazine 1.5 mg orally once a day for 6 weeks.

Treatment:

Drug: Cariprazine

Cariprazine 3.0 mg

Experimental group

Description:

Participants received cariprazine 3.0 mg orally once a day for 6 weeks.

Treatment:

Drug: Cariprazine

Cariprazine 4.5 mg

Experimental group

Description:

Participants received cariprazine 4.5 mg orally once a day for 6 weeks.

Treatment:

Drug: Cariprazine

Risperidone 4.0 mg

Active Comparator group

Description:

Participants received risperidone 4.0 mg orally once a day for 6 weeks.

Treatment:

Drug: Risperidone