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A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03573297
Recruitment Status : Active, not recruiting
First Posted : June 29, 2018
Last Update Posted : August 16, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/d compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/d

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Mania Depression Drug: Cariprazine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 822 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : September 12, 2022
Estimated Study Completion Date : September 12, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cariprazine 3 mg/day
Cariprazine capsules, oral administration, once daily
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily

Experimental: Cariprazine 1.5 mg/day
Cariprazine capsules, oral administration, once daily
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily

Placebo Comparator: Placebo
Matching placebo capsules, oral administration, once daily
Drug: Placebo
Matching placebo capsules, oral administration, once daily




Primary Outcome Measures :
  1. Number of days to first relapse of any mood episode during the double-blind treatment period [ Time Frame: From Visit 11 (Week 12) up to Visit 32 (Week 52) ]

    Relapse will be defined as the occurrence of any 1 of the following:

    • Young Mania Rating Score (YMRS) total score ≥ 17
    • Montgomery Asberg Depression Rating Scale; (MADRS) total score ≥ 20;
    • Clinical Global Impression-Improvement scale (CGI-S) ≥ 4;
    • Initiation of additional psychiatric medication;
    • Psychiatric hospitalization;
    • Exacerbation of illness as judged by clinical impression of the Investigator



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, current episode manic, with or without mixed features;
  • A total YMRS score ≥ 20 and a score of at least 4 on 2 of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior, or bipolar I disorder, current episode depressive, with or without mixed features;
  • Having a MADRS total score ≥ 23 and a score of at least 3 on 2 of the following MADRS items: apparent sadness, reported sadness, inner tension or inability to feel.

Exclusion Criteria:

  • Four or more episodes of a mood disturbance within the 12 months before Visit 1;
  • Diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.

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): NCT03573297


Locations
Show Show 113 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: ALLERGAN INC. Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03573297    
Other Study ID Numbers: RGH-MD-25
2017-000803-25 ( EudraCT Number )
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: August 16, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing, please refer to the link below
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Disease
Pathologic Processes
Cariprazine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs