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

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ClinicalTrials.gov Identifier: NCT01412060
Recruitment Status : Completed
First Posted : August 8, 2011
Results First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Placebo Drug: Cariprazine Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 765 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: There was no masking in the Open-Label Phase. There was masking in the Double-Blind Phase
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia
Actual Study Start Date : September 27, 2011
Actual Primary Completion Date : September 3, 2014
Actual Study Completion Date : September 3, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Cariprazine - Open-label Phase
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.
Drug: Cariprazine
Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
Other Name: RGH-188

Experimental: Placebo - Double-blind Treatment Phase
Participants received placebo orally once a day for 26 to 72 weeks.
Drug: Placebo
Placebo was supplied in capsules.

Experimental: Cariprazine - Double-blind Treatment Phase
Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks
Drug: Cariprazine
Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
Other Name: RGH-188




Primary Outcome Measures :
  1. Time From Baseline to the First Symptom Relapse During the Double-blind Phase [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412060


  Show 73 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Willie Earley Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01412060     History of Changes
Other Study ID Numbers: RGH-MD-06
2011-002048-29 ( EudraCT Number )
First Posted: August 8, 2011    Key Record Dates
Results First Posted: July 6, 2018
Last Update Posted: July 6, 2018
Last Verified: June 2018

Keywords provided by Forest Laboratories:
Schizophrenia
Schizophrenic disorder

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders