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
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University of South Florida The University of South Florida is a high-impact, global research university...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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1010 West Chapman Avenue
Orange, California 93868
Orange, California 93868
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