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Trial record 3 of 11 for:    Recruiting, Not yet recruiting, Available Studies | Mania

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

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ClinicalTrials.gov Identifier: NCT03573297
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

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 15, 2018
Estimated Primary Completion Date : July 17, 2021
Estimated Study Completion Date : July 17, 2021

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


Contacts
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Contact: Clinical Trial Registry Team 877-277-8566 IR-CTRegistration@allergan.com

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Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Andrea Sawdon Forest Laboratories, an Allergan affiliate

Additional Information:
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT03573297     History of Changes
Other Study ID Numbers: RGH-MD-25
2017-000803-25 ( EudraCT Number )
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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