NCT01412060

A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 765 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.

Detailed description

There were 3 periods (phases) in the study. The Open-label Phase lasted 20 weeks. In the first 6 weeks, participants received 3, 6, or 9 mg cariprazine orally once a day; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this Open-label Phase. At the end of Week 8, participants had to meet the following criteria to continue in the study. * Positive and Negative Syndrome Scale (PANSS) total score ≤ 60 at the end of Week 8 * At least 20% decrease in PANSS total score from baseline to the end of Week 8 * Clinical Global Impressions - Severity (CGI-S) score ≤ 4 at the end of Week 8 * Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 8 * Stable dose during the previous 2 weeks * No significant tolerability issues as judged by the Investigator at the end of Week 8 At the end of the Open-label Phase, participants were randomized into 2 treatment groups, cariprazine or placebo, if they met the following criteria: * PANSS total score ≤ 60 at the end of Week 20 * At least 20% decrease in PANSS total score from baseline to the end of Week 20 * CGI-S score ≤ 4 at the end of Week 20 * Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 20 * No significant tolerability issues as judged by the Investigator During this Double-blind Treatment Phase, participants received either placebo or cariprazine at the same dosage (3, 6, or 9 mg) that they received during the last 14 weeks of the Open-label Phase. All participants entered the 4 week Safety Follow-up Phase. They received a treatment other than the investigational product at the discretion of the Investigator.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Placebo	Placebo was supplied in capsules.
DRUG	Cariprazine	Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.

Timeline

• Start date: 2011-09-27
• Primary completion: 2014-09-03
• Completion: 2014-09-03
• First posted: 2011-08-08
• Last updated: 2018-07-06
• Results posted: 2018-07-06

Locations

73 sites across 5 countries: United States, India, Romania, Slovakia, Ukraine