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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Cariprazine
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, Schizophrenic disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Forest Investigative Site 011
  • Forest Investigative Site 018
  • Forest Investigative Site 007
  • Forest Investigative Site 026
  • Forest Investigative Site 008
  • Forest Investigative Site 002
  • Forest Investigative Site 019
  • Forest Investigative Site 001
  • Forest Investigative Site 020
  • Forest Investigative Site 005
  • Forest Investigative Site 024
  • Forest Investigative Site 017
  • Forest Investigative Site 021
  • Forest Investigative Site 023
  • Forest Investigative Site 010
  • Forest Investigative Site 003
  • Forest Investigative Site 006
  • Forest Investigative Site 014
  • Forest Investigative Site 012
  • Forest Investigative Site 022
  • Forest Investigative Site 015
  • Forest Investigative Site 027
  • Forest Investigative Site 025
  • Forest Investigative Site 013
  • Forest Investigative Site 009
  • Forest Investigative Site 305
  • Forest Investigative Site 303
  • Forest Investigative Site 308
  • Forest Investigative Site 310
  • Forest Investigative Site 313
  • Forest Investigative Site 314
  • Forest Investigative Site 301
  • Forest Investigative Site 306
  • Forest Investigative Site 311
  • Forest Investigative Site 317
  • Forest Investigative Site 302
  • Forest Investigative Site 312
  • Forest Investigative Site 309
  • Forest Investigative Site 304
  • Forest Investigative Site 307
  • Forest Investigative Site 403
  • Forest Investigative Site 405
  • Forest Investigative Site 406
  • Forest Investigative Site 408
  • Forest Investigative Site 410
  • Forest Investigative Site 407
  • Forest Investigative Site 412
  • Forest Investigative Site 402
  • Forest Investigative Site 411
  • Forest Investigative Site 401
  • Forest Investigative Site 409
  • Forest Investigative Site 404
  • Forest Investigative Site 508
  • Forest Investigative Site 507
  • Forest Investigative Site 504
  • Forest Investigative Site 505
  • Forest Investigative Site 503
  • Forest Investigative Site 506
  • Forest Investigative Site 609
  • Forest Investigative Site 610
  • Forest Investigative Site 613
  • Forest Investigative Site 616
  • Forest Investigative Site 605
  • Forest Investigative Site 606
  • Forest Investigative Site 604
  • Forest Investigative Site 607
  • Forest Investigative Site 602
  • Forest Investigative Site 601
  • Forest Investigative Site 612
  • Forest Investigative Site 603
  • Forest Investigative Site 615
  • Forest Investigative Site 611
  • Forest Investigative Site 608

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cariprazine - Open-label Phase

Placebo - Double-blind Treatment Phase

Cariprazine - Double-blind Treatment Phase

Arm Description

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.

Participants received placebo orally once a day for 26 to 72 weeks.

Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2011
Last Updated
June 5, 2018
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01412060
Brief Title
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 27, 2011 (Actual)
Primary Completion Date
September 3, 2014 (Actual)
Study Completion Date
September 3, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Schizophrenic disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
There was no masking in the Open-Label Phase. There was masking in the Double-Blind Phase
Allocation
Randomized
Enrollment
765 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cariprazine - Open-label Phase
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo - Double-blind Treatment Phase
Arm Type
Experimental
Arm Description
Participants received placebo orally once a day for 26 to 72 weeks.
Arm Title
Cariprazine - Double-blind Treatment Phase
Arm Type
Experimental
Arm Description
Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was supplied in capsules.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Other Intervention Name(s)
RGH-188
Intervention Description
Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
Primary Outcome Measure Information:
Title
Time From Baseline to the First Symptom Relapse During the Double-blind Phase
Description
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.
Time Frame
Up to 34 Weeks and Bi-Weekly thereafter until Week 92

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willie Earley
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 011
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Forest Investigative Site 018
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Forest Investigative Site 007
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 026
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Forest Investigative Site 008
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Forest Investigative Site 002
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 019
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigative Site 001
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Forest Investigative Site 020
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Forest Investigative Site 005
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Forest Investigative Site 024
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Forest Investigative Site 017
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Forest Investigative Site 021
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Forest Investigative Site 023
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Forest Investigative Site 010
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Forest Investigative Site 003
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Forest Investigative Site 006
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 014
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 012
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Forest Investigative Site 022
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Forest Investigative Site 015
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Forest Investigative Site 027
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Forest Investigative Site 025
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Forest Investigative Site 013
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Forest Investigative Site 009
City
Houston
State/Province
Texas
ZIP/Postal Code
77021
Country
United States
Facility Name
Forest Investigative Site 305
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Facility Name
Forest Investigative Site 303
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Forest Investigative Site 308
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Facility Name
Forest Investigative Site 310
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Forest Investigative Site 313
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575018
Country
India
Facility Name
Forest Investigative Site 314
City
Manipal
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India
Facility Name
Forest Investigative Site 301
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431005
Country
India
Facility Name
Forest Investigative Site 306
City
Kalyan
State/Province
Maharashtra
ZIP/Postal Code
421301
Country
India
Facility Name
Forest Investigative Site 311
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422101
Country
India
Facility Name
Forest Investigative Site 317
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302021
Country
India
Facility Name
Forest Investigative Site 302
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
303706
Country
India
Facility Name
Forest Investigative Site 312
City
Madurai
State/Province
Tamilnadu
ZIP/Postal Code
625020
Country
India
Facility Name
Forest Investigative Site 309
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208005
Country
India
Facility Name
Forest Investigative Site 304
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Forest Investigative Site 307
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221005
Country
India
Facility Name
Forest Investigative Site 403
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Forest Investigative Site 405
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Forest Investigative Site 406
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Forest Investigative Site 408
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Forest Investigative Site 410
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Forest Investigative Site 407
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Facility Name
Forest Investigative Site 412
City
Campulung
ZIP/Postal Code
115100
Country
Romania
Facility Name
Forest Investigative Site 402
City
Constanta
ZIP/Postal Code
900002
Country
Romania
Facility Name
Forest Investigative Site 411
City
Focsani
ZIP/Postal Code
620165
Country
Romania
Facility Name
Forest Investigative Site 401
City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Forest Investigative Site 409
City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Forest Investigative Site 404
City
Targoviste
ZIP/Postal Code
130086
Country
Romania
Facility Name
Forest Investigative Site 508
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Facility Name
Forest Investigative Site 507
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Forest Investigative Site 504
City
Liptovsky Mikulas
ZIP/Postal Code
03125
Country
Slovakia
Facility Name
Forest Investigative Site 505
City
Rimavska Sobota
ZIP/Postal Code
97912
Country
Slovakia
Facility Name
Forest Investigative Site 503
City
Roznava
ZIP/Postal Code
04801
Country
Slovakia
Facility Name
Forest Investigative Site 506
City
Trnava
ZIP/Postal Code
91701
Country
Slovakia
Facility Name
Forest Investigative Site 609
City
Kerch
State/Province
AR Crimea
ZIP/Postal Code
98310
Country
Ukraine
Facility Name
Forest Investigative Site 610
City
Dnipropetrovsk
ZIP/Postal Code
49115
Country
Ukraine
Facility Name
Forest Investigative Site 613
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
Facility Name
Forest Investigative Site 616
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Forest Investigative Site 605
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site 606
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site 604
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Forest Investigative Site 607
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Forest Investigative Site 602
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Forest Investigative Site 601
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Forest Investigative Site 612
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Forest Investigative Site 603
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Forest Investigative Site 615
City
Odesa
ZIP/Postal Code
65014
Country
Ukraine
Facility Name
Forest Investigative Site 611
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
Forest Investigative Site 608
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34091867
Citation
Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.
Results Reference
derived
PubMed Identifier
33854317
Citation
Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021. Erratum In: Neuropsychiatr Dis Treat. 2021 May 17;17:1481.
Results Reference
derived
PubMed Identifier
30695290
Citation
Correll CU, Potkin SG, Zhong Y, Harsanyi J, Szatmari B, Earley W. Long-Term Remission With Cariprazine Treatment in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Trial. J Clin Psychiatry. 2019 Jan 8;80(2):18m12495. doi: 10.4088/JCP.18m12495.
Results Reference
derived
PubMed Identifier
27427558
Citation
Durgam S, Earley W, Li R, Li D, Lu K, Laszlovszky I, Fleischhacker WW, Nasrallah HA. Long-term cariprazine treatment for the prevention of relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled trial. Schizophr Res. 2016 Oct;176(2-3):264-271. doi: 10.1016/j.schres.2016.06.030. Epub 2016 Jul 15. Erratum In: Schizophr Res. 2018 Feb;192:493.
Results Reference
derived

Learn more about this trial

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

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