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 |
|---|---|
| Conditions: | Depression, Psychiatric, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 7/1/2018 |
| Start Date: | June 15, 2018 |
| End Date: | July 17, 2021 |
| Contact: | Clinical Trial Registry Team |
| Email: | IR-CTRegistration@allergan.com |
| Phone: | 877-277-8566 |
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
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
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
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
We found this trial at
42
sites
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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University of South Florida The University of South Florida is a high-impact, global research university...
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1010 West Chapman Avenue
Orange, California 93868
Orange, California 93868
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