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

  • STATUS
    Recruiting
  • End date
    Jul 22, 2023
  • participants needed
    822
  • sponsor
    Allergan
Updated on 19 July 2021
psychiatric disorder
mania
tension
cariprazine
bipolar i disorder

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

Details
Condition Endogenous depression, Depression, Bipolar Disorder, Depression (Major/Severe), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Bipolar I Disorder, Depressed, Bipolar Disorders (Pediatric), Manic Disorders, depressive disorder, mania, depressed mood, miserable, depressive disorders
Treatment Placebo, cariprazine
Clinical Study IdentifierNCT03573297
SponsorAllergan
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

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
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