Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT01412060
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2011-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
Sponsor:
Forest Laboratories
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-002048-29 | EUDRACT_NUMBER | None | View |