A Study of Cariprazine in the Prevention of Relapse of Symptoms in

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Schizophrenia

Clinical Trial Details

NCT number	NCT01412060
Study type	Interventional
Source	Forest Laboratories
Contact
Status	Completed
Phase	Phase 3
Start date	September 27, 2011
Completion date	September 3, 2014

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms