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

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412060
• Other study ID #: RGH-MD-06
• Secondary ID: 2011-002048-29
• Status: Completed
• Phase: Phase 3
• Start date: September 27, 2011
• Est. completion date: September 3, 2014

Study information

• Verified date: June 2018
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 765
• Est. completion date: September 3, 2014
• Est. primary completion date: September 3, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Placebo
Placebo was supplied in capsules.
• Cariprazine
Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.

Locations

Country	Name	City	State
India	Forest Investigative Site 303	Ahmedabad	Gujarat
India	Forest Investigative Site 308	Ahmedabad	Gujarat
India	Forest Investigative Site 310	Ahmedabad	Gujarat
India	Forest Investigative Site 301	Aurangabad	Maharashtra
India	Forest Investigative Site 302	Jaipur	Rajasthan
India	Forest Investigative Site 317	Jaipur	Rajasthan
India	Forest Investigative Site 306	Kalyan	Maharashtra
India	Forest Investigative Site 309	Kanpur	Uttar Pradesh
India	Forest Investigative Site 304	Lucknow	Uttar Pradesh
India	Forest Investigative Site 312	Madurai	Tamilnadu
India	Forest Investigative Site 313	Mangalore	Karnataka
India	Forest Investigative Site 314	Manipal	Karnataka
India	Forest Investigative Site 311	Nashik	Maharashtra
India	Forest Investigative Site 307	Varanasi	Uttar Pradesh
India	Forest Investigative Site 305	Vijayawada	Andhra Pradesh
Romania	Forest Investigative Site 403	Bucuresti
Romania	Forest Investigative Site 405	Bucuresti
Romania	Forest Investigative Site 406	Bucuresti
Romania	Forest Investigative Site 408	Bucuresti
Romania	Forest Investigative Site 410	Bucuresti
Romania	Forest Investigative Site 407	Campulung
Romania	Forest Investigative Site 412	Campulung
Romania	Forest Investigative Site 402	Constanta
Romania	Forest Investigative Site 411	Focsani
Romania	Forest Investigative Site 401	Iasi
Romania	Forest Investigative Site 409	Iasi
Romania	Forest Investigative Site 404	Targoviste
Slovakia	Forest Investigative Site 507	Bratislava
Slovakia	Forest Investigative Site 508	Bratislava
Slovakia	Forest Investigative Site 504	Liptovsky Mikulas
Slovakia	Forest Investigative Site 505	Rimavska Sobota
Slovakia	Forest Investigative Site 503	Roznava
Slovakia	Forest Investigative Site 506	Trnava
Ukraine	Forest Investigative Site 610	Dnipropetrovsk
Ukraine	Forest Investigative Site 613	Donetsk
Ukraine	Forest Investigative Site 616	Ivano-Frankivsk
Ukraine	Forest Investigative Site 609	Kerch	AR Crimea
Ukraine	Forest Investigative Site 604	Kharkiv
Ukraine	Forest Investigative Site 605	Kharkiv
Ukraine	Forest Investigative Site 606	Kharkiv
Ukraine	Forest Investigative Site 607	Kherson
Ukraine	Forest Investigative Site 601	Kyiv
Ukraine	Forest Investigative Site 602	Kyiv
Ukraine	Forest Investigative Site 612	Kyiv
Ukraine	Forest Investigative Site 603	Lviv
Ukraine	Forest Investigative Site 615	Odesa
Ukraine	Forest Investigative Site 611	Simferopol
Ukraine	Forest Investigative Site 608	Vinnytsia
United States	Forest Investigative Site 017	Atlanta	Georgia
United States	Forest Investigative Site 015	Austin	Texas
United States	Forest Investigative Site 027	Austin	Texas
United States	Forest Investigative Site 023	Baltimore	Maryland
United States	Forest Investigative Site 012	Cedarhurst	New York
United States	Forest Investigative Site 018	Cerritos	California
United States	Forest Investigative Site 021	Chicago	Illinois
United States	Forest Investigative Site 007	Costa Mesa	California
United States	Forest Investigative Site 006	Creve Coeur	Missouri
United States	Forest Investigative Site 026	Culver City	California
United States	Forest Investigative Site 025	Dallas	Texas
United States	Forest Investigative Site 022	Dayton	Ohio
United States	Forest Investigative Site 003	Flowood	Mississippi
United States	Forest Investigative Site 009	Houston	Texas
United States	Forest Investigative Site 013	Houston	Texas
United States	Forest Investigative Site 024	Leesburg	Florida
United States	Forest Investigative Site 011	Little Rock	Arkansas
United States	Forest Investigative Site 008	Long Beach	California
United States	Forest Investigative Site 002	Oceanside	California
United States	Forest Investigative Site 019	Orange	California
United States	Forest Investigative Site 001	Paramount	California
United States	Forest Investigative Site 010	Rockville	Maryland
United States	Forest Investigative Site 014	Saint Louis	Missouri
United States	Forest Investigative Site 020	San Diego	California
United States	Forest Investigative Site 005	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Gedeon Richter Ltd.

Countries where clinical trial is conducted

United States,  India,  Romania,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From Baseline to the First Symptom Relapse During the Double-blind Phase	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.	Up to 34 Weeks and Bi-Weekly thereafter until Week 92