Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Forest Laboratories
With
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.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
