A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Cariprazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00839852

RGH-MD-17

Details and patient eligibility

About

This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Enrollment: 97 patients

Sex: All

Ages: 18 to 61 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have completed the double-blind treatment period of the lead-in study RGH-MD-16 (NCT 00694707)
• Patients who have responded to double-blind treatment in the lead-in study as defined as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S) score of ≤ 3.
• Patients eligible to continue as outpatients based on the opinion of the Principal Investigator.
• Patients must have a caregiver to ensure treatment compliance.

Exclusion criteria

• Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

Cariprazine 1.5mg

Experimental group

Description:

Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability

Treatment:

Drug: Cariprazine