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
- Conditions
- Bipolar I DisorderManiaDepression
- Interventions
- Drug: Placebo
- Registration Number
- NCT03573297
- Lead Sponsor
- AbbVie
- Brief Summary
1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day 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/day 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/day
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 901
- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, and at least one of the following two criteria:
- Current episode manic, with or without mixed features, having a total Young Mania Rating Scale (YMRS) total score ≥ 20 and a score of at least 4 on 2 YMRS items (irritability, speech, content, or disruptive/aggressive behavior);
- OR current episode depressive, with or without mixed features, having a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 23 and a score of at least 3 on 2 MADRS items (apparent sadness, reported sadness, inner tension or inability to feel).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-Blind Cariprazine 1.5 mg/day Cariprazine Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks. Double-Blind Placebo Placebo Participants randomized to receive placebo QD for up to 39 weeks. Open Label Treatment Cariprazine Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks. Double-Blind Cariprazine 3.0 mg/day Cariprazine Participants randomized to receive cariprazine 3.0 mg once daily (QD) for up to 39 weeks.
- Primary Outcome Measures
Name Time Method Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period From Week 16 to Week 55 Relapse was defined as the occurrence of any 1 of the following:
* Young Mania Rating Score (YMRS) total score ≥ 17 (range 0-60; higher score indicates a worse outcome);
* Montgomery Asberg Depression Rating Scale; (MADRS) total score ≥ 20 (range 0-60; higher score indicates more depressive symptoms);
* Clinical Global Impression-Improvement scale (CGI-S) ≥ 4 (range from 1 \[normal, not at all ill\] to 7 \[extremely ill\]);
* Initiation of additional psychiatric medication;
* Psychiatric hospitalization;
* Exacerbation of illness as judged by clinical impression of the Investigator.
Time to first relapse (days) was calculated as the date of the first relapse - the date of randomization + 1. Participants who did not meet the relapse criteria were considered censored at the time of completion or discontinuation from the Double-Blind Treatment Period (DBTP) of the study. Percentiles (95% Confidence Intervals \[CI\]) are based on Kaplan-Meier estimates.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (108)
Woodland International Research Group /ID# 232932
🇺🇸Little Rock, Arkansas, United States
Woodland Research Northwest, LLC /ID# 232982
🇺🇸Rogers, Arkansas, United States
California Pharmaceutical Research Institute Inc. /ID# 232745
🇺🇸Anaheim, California, United States
Advanced Research Center /ID# 233120
🇺🇸Anaheim, California, United States
CI Trials /ID# 232642
🇺🇸Bellflower, California, United States
Synexus Clinical Research US Inc. /ID# 232743
🇺🇸Cerritos, California, United States
ATP Clinical Research, Inc /ID# 232979
🇺🇸Costa Mesa, California, United States
ProScience Research Group /ID# 232945
🇺🇸Culver City, California, United States
Collaborative Neuroscience Research - Orange County /ID# 233077
🇺🇸Garden Grove, California, United States
Behavioral Research Specialists, LLC /ID# 232980
🇺🇸Glendale, California, United States
Scroll for more (98 remaining)Woodland International Research Group /ID# 232932🇺🇸Little Rock, Arkansas, United States