Conditions: Schizophrenia
Keywords: Schizophrenia Schizophrenic disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 765
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; 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 20 week Open-label Phase. arm 2: Participants received placebo orally once a day for 26 to 72 weeks. arm 3: Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks

Interventions: intervention 1: Placebo intervention 2: Cariprazine
Intervention descriptions: intervention 1: Placebo was supplied in capsules. intervention 2: Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.

Protocol document: