A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
- Registration Number
- NCT01412060
- Lead Sponsor
- Forest Laboratories
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 765
- Participants who have provided informed consent prior to any study specific procedures.
- Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.
- Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
- Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
- Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
- Body mass index between 18 and 40 kg/m^2, inclusive.
- Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
- Participants in their first episode of psychosis.
- Treatment-resistant schizophrenia over the last 2 years.
- Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
- At imminent risk of injuring self or others or causing significant damage to property.
- Suicide risk.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo - Double-blind Treatment Phase Placebo Participants received placebo orally once a day for 26 to 72 weeks. Cariprazine - Open-label Phase Cariprazine 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. Cariprazine - Double-blind Treatment Phase Cariprazine Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks
- Primary Outcome Measures
Name Time Method Time From Baseline to the First Symptom Relapse During the Double-blind Phase Up to 34 Weeks and Bi-Weekly thereafter until Week 92 Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored \<50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of \>4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not performed based on Investigator discretion.
PANSS is 30-item rating scale. Each item scored on 7-point scale. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms. CGI-S is 7-point scale,measures severity of participant's illness in comparison with others with same diagnosis. Lower score indicates less severe illness. 25th percentile for time to relapse was reported.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (73)
Forest Investigative Site 002
🇺🇸Oceanside, California, United States
Forest Investigative Site 008
🇺🇸Long Beach, California, United States
Forest Investigative Site 011
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 026
🇺🇸Culver City, California, United States
Forest Investigative Site 018
🇺🇸Cerritos, California, United States
Forest Investigative Site 305
🇮🇳Vijayawada, Andhra Pradesh, India
Forest Investigative Site 001
🇺🇸Paramount, California, United States
Forest Investigative Site 605
🇺🇦Kharkiv, Ukraine
Forest Investigative Site 607
🇺🇦Kherson, Ukraine
Forest Investigative Site 602
🇺🇦Kyiv, Ukraine
Forest Investigative Site 314
🇮🇳Manipal, Karnataka, India
Forest Investigative Site 404
🇷🇴Targoviste, Romania
Forest Investigative Site 507
🇸🇰Bratislava, Slovakia
Forest Investigative Site 408
🇷🇴Bucuresti, Romania
Forest Investigative Site 410
🇷🇴Bucuresti, Romania
Forest Investigative Site 412
🇷🇴Campulung, Romania
Forest Investigative Site 504
🇸🇰Liptovsky Mikulas, Slovakia
Forest Investigative Site 409
🇷🇴Iasi, Romania
Forest Investigative Site 604
🇺🇦Kharkiv, Ukraine
Forest Investigative Site 608
🇺🇦Vinnytsia, Ukraine
Forest Investigative Site 503
🇸🇰Roznava, Slovakia
Forest Investigative Site 007
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 023
🇺🇸Baltimore, Maryland, United States
Forest Investigative Site 020
🇺🇸San Diego, California, United States
Forest Investigative Site 017
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 013
🇺🇸Houston, Texas, United States
Forest Investigative Site 009
🇺🇸Houston, Texas, United States
Forest Investigative Site 302
🇮🇳Jaipur, Rajasthan, India
Forest Investigative Site 303
🇮🇳Ahmedabad, Gujarat, India
Forest Investigative Site 304
🇮🇳Lucknow, Uttar Pradesh, India
Forest Investigative Site 401
🇷🇴Iasi, Romania
Forest Investigative Site 508
🇸🇰Bratislava, Slovakia
Forest Investigative Site 311
🇮🇳Nashik, Maharashtra, India
Forest Investigative Site 309
🇮🇳Kanpur, Uttar Pradesh, India
Forest Investigative Site 317
🇮🇳Jaipur, Rajasthan, India
Forest Investigative Site 003
🇺🇸Flowood, Mississippi, United States
Forest Investigative Site 021
🇺🇸Chicago, Illinois, United States
Forest Investigative Site 027
🇺🇸Austin, Texas, United States
Forest Investigative Site 019
🇺🇸Orange, California, United States
Forest Investigative Site 005
🇺🇸Washington, District of Columbia, United States
Forest Investigative Site 024
🇺🇸Leesburg, Florida, United States
Forest Investigative Site 012
🇺🇸Cedarhurst, New York, United States
Forest Investigative Site 006
🇺🇸Creve Coeur, Missouri, United States
Forest Investigative Site 010
🇺🇸Rockville, Maryland, United States
Forest Investigative Site 014
🇺🇸Saint Louis, Missouri, United States
Forest Investigative Site 022
🇺🇸Dayton, Ohio, United States
Forest Investigative Site 025
🇺🇸Dallas, Texas, United States
Forest Investigative Site 015
🇺🇸Austin, Texas, United States
Forest Investigative Site 308
🇮🇳Ahmedabad, Gujarat, India
Forest Investigative Site 310
🇮🇳Ahmedabad, Gujarat, India
Forest Investigative Site 313
🇮🇳Mangalore, Karnataka, India
Forest Investigative Site 306
🇮🇳Kalyan, Maharashtra, India
Forest Investigative Site 312
🇮🇳Madurai, Tamilnadu, India
Forest Investigative Site 405
🇷🇴Bucuresti, Romania
Forest Investigative Site 403
🇷🇴Bucuresti, Romania
Forest Investigative Site 406
🇷🇴Bucuresti, Romania
Forest Investigative Site 411
🇷🇴Focsani, Romania
Forest Investigative Site 407
🇷🇴Campulung, Romania
Forest Investigative Site 402
🇷🇴Constanta, Romania
Forest Investigative Site 506
🇸🇰Trnava, Slovakia
Forest Investigative Site 613
🇺🇦Donetsk, Ukraine
Forest Investigative Site 609
🇺🇦Kerch, AR Crimea, Ukraine
Forest Investigative Site 610
🇺🇦Dnipropetrovsk, Ukraine
Forest Investigative Site 616
🇺🇦Ivano-Frankivsk, Ukraine
Forest Investigative Site 606
🇺🇦Kharkiv, Ukraine
Forest Investigative Site 601
🇺🇦Kyiv, Ukraine
Forest Investigative Site 603
🇺🇦Lviv, Ukraine
Forest Investigative Site 615
🇺🇦Odesa, Ukraine
Forest Investigative Site 611
🇺🇦Simferopol, Ukraine
Forest Investigative Site 505
🇸🇰Rimavska Sobota, Slovakia
Forest Investigative Site 612
🇺🇦Kyiv, Ukraine
Forest Investigative Site 307
🇮🇳Varanasi, Uttar Pradesh, India
Forest Investigative Site 301
🇮🇳Aurangabad, Maharashtra, India