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)
Synexus Clinical Research, Inc /ID# 232950
🇺🇸Atlanta, Georgia, United States
Atlanta Center for Medical Research /ID# 232832
🇺🇸Atlanta, Georgia, United States
NRC Research Institute /ID# 232741
🇺🇸Orange, California, United States
Duplicate_Altea Research Institute /ID# 232784
🇺🇸Las Vegas, Nevada, United States
CNRI-San Diego /ID# 232748
🇺🇸San Diego, California, United States
UMHAT Dr Georgi Stranski EAD /ID# 233105
🇧🇬Pleven, Bulgaria
Woodland International Research Group /ID# 232932
🇺🇸Little Rock, Arkansas, United States
Hospital Raja Permaisuri Bainun /ID# 233114
🇲🇾Ipoh, Perak, Malaysia
Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas /ID# 232777
🇧🇬Burgas, Bulgaria
University Malaya Med Ctr /ID# 233108
🇲🇾Kuala Lumpur, Malaysia
National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232928
🇷🇺St. Petersburg, Russian Federation
University Clinical Center Kragujevac /ID# 233096
🇷🇸Kragujevac, Sumadijski Okrug, Serbia
China Medical University Hospital /ID# 233091
🇨🇳Taichung City, Taiwan
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232938
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 232848
🇵🇱Gdansk, Pomorskie, Poland
State Psychiatric Hospital - Lovech /ID# 232771
🇧🇬Lovech, Bulgaria
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232937
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Institute of Mental Health /ID# 232958
🇷🇸Belgrade, Serbia
Geikivka multidisciplinary hospital for psychiatric care /ID# 232678
🇺🇦Kryvbas Village, Dnipropetrovska Oblast, Ukraine
Vinnytsia Regional Psycho-Neurological Hospital /ID# 232852
🇺🇦Vinnytsia, Ukraine
Mental Health Research Centre /ID# 232864
🇷🇺Moscow, Russian Federation
Region Specialized Psychiatric Hospital #2 /ID# 232850
🇷🇺Tonnelniy, Russian Federation
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 232641
🇷🇸Belgrade, Serbia
Special Hospital for Psychiatric Diseases Kovin /ID# 232829
🇷🇸Kovin, Serbia
Clinical Center Vojvodina /ID# 233038
🇷🇸Novi Sad, Vojvodina, Serbia
New Hope Clinical Research Inc. /ID# 232716
🇺🇸Charlotte, North Carolina, United States
Family Psychiatry of The Woodlands /ID# 232943
🇺🇸The Woodlands, Texas, United States
Woodland Research Northwest, LLC /ID# 232982
🇺🇸Rogers, Arkansas, United States
Advanced Research Center /ID# 233120
🇺🇸Anaheim, California, United States
CBH Health LLC /ID# 232699
🇺🇸Gaithersburg, Maryland, United States
Neurobehavioral Research Inc /ID# 232791
🇺🇸Cedarhurst, New York, United States
Louisiana Clinical Research /ID# 232685
🇺🇸Shreveport, Louisiana, United States
Hassman Research Institute /ID# 233088
🇺🇸Berlin, New Jersey, United States
Collaborative Neuroscience Research LLC /ID# 232750
🇺🇸Torrance, California, United States
ProScience Research Group /ID# 232945
🇺🇸Culver City, California, United States
Artemis Institute for Clinical Research /ID# 233152
🇺🇸San Marcos, California, United States
CenExcel iResearch LLC /ID# 233045
🇺🇸Decatur, Georgia, United States
NeuroPsychiatric Research Practice & Associate LTD /ID# 232840
🇺🇸Winfield, Illinois, United States
DUPLICATE_The Ohios State University Department of Psychiatry /ID# 232739
🇺🇸Columbus, Ohio, United States
Research Centers of America - Hollywood FL /ID# 232649
🇺🇸Hollywood, Florida, United States
Pillar Clinical Research LLC /ID# 232667
🇺🇸Richardson, Texas, United States
California Pharmaceutical Research Institute Inc. /ID# 232745
🇺🇸Anaheim, California, United States
Duplicate_MCB Clinical Research Centers LLC /ID# 232838
🇺🇸Colorado Springs, Colorado, United States
Atlanta Behavioral Research, LLC /ID# 232935
🇺🇸Dunwoody, Georgia, United States
CNS Healthcare - Jacksonville /ID# 233160
🇺🇸Jacksonville, Florida, United States
Meridien Research /ID# 232941
🇺🇸Maitland, Florida, United States
State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 232779
🇧🇬Kardzhali, Bulgaria
Clinic of Child Psychiatry St Nicolas /ID# 232925
🇧🇬Sofia, Bulgaria
Inje University Busan Paik Hospital /ID# 233097
🇰🇷Busan, Korea, Republic of
Specjalistyczny Gabinet Lekarski /ID# 232702
🇵🇱Lublin, Lubelskie, Poland
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 232946
🇷🇺Nizhny Novgorod, Russian Federation
Poradnia Zdrowia Psychicznego /ID# 232878
🇵🇱Chelmno, Poland
INSPIRA Clinical Research /ID# 232704
🇵🇷San Juan, Puerto Rico
State Public Institution of Healthcare Leningrad Regional Psychoneurology Dispen /ID# 232872
🇷🇺Roschino, Russian Federation
I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 232930
🇷🇺Saint Petersburg, Russian Federation
St. Nicolas Psychiatric Hospital /ID# 232858
🇷🇺Saint-Petersburg, Russian Federation
St. Nicolas Psychiatric Hospital /ID# 232859
🇷🇺Saint-Petersburg, Russian Federation
National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232927
🇷🇺St. Petersburg, Russian Federation
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 232846
🇷🇸Novi Knezevac, Serbia
SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232939
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 232684
🇺🇦Stepanivka Village, Khersonska Oblast, Ukraine
CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU /ID# 232853
🇺🇦Vinnytsia, Ukraine
Sooner Clinical Research /ID# 232931
🇺🇸Oklahoma City, Oklahoma, United States
Inje University Haeundae Hospital /ID# 233141
🇰🇷Busan, Korea, Republic of
Jeju National University Hospital /ID# 233104
🇰🇷Jeju, Korea, Republic of
Chonnam National University Hospital /ID# 233098
🇰🇷Gwangju, Korea, Republic of
St. Charles Psychiatric Associates - Midwest Research Group /ID# 232709
🇺🇸Saint Charles, Missouri, United States
Synexus Clinical Research US Inc. /ID# 232743
🇺🇸Cerritos, California, United States
Velocity Clinical Research - Hallandale Beach /ID# 232647
🇺🇸Hallandale Beach, Florida, United States
Community Clinical Research Inc. /ID# 232672
🇺🇸Austin, Texas, United States
Miami Lakes Medical Research /ID# 232826
🇺🇸Miami Lakes, Florida, United States
Pillar Clinical Research LLC /ID# 232673
🇺🇸Richardson, Texas, United States
Midwest Clinical Research Center /ID# 232737
🇺🇸Dayton, Ohio, United States
CI Trials /ID# 232642
🇺🇸Bellflower, California, United States
Collaborative Neuroscience Research - Orange County /ID# 233077
🇺🇸Garden Grove, California, United States
ATP Clinical Research, Inc /ID# 232979
🇺🇸Costa Mesa, California, United States
Alliance for Research - Long Beach /ID# 232926
🇺🇸Long Beach, California, United States
Behavioral Research Specialists, LLC /ID# 232980
🇺🇸Glendale, California, United States
Synergy San Diego /ID# 232740
🇺🇸Lemon Grove, California, United States
Omega Clinical Trials LLC /ID# 233150
🇺🇸La Habra, California, United States
Artemis Institute for Clinical Research /ID# 233151
🇺🇸San Marcos, California, United States
Clinical Inquest Center Ltd /ID# 233043
🇺🇸Beavercreek, Ohio, United States
Second Psychiatric Clinic for General Psychiatry and Addictions of UMHAT Dr. Geo /ID# 232773
🇧🇬Pleven, Bulgaria
MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 232893
🇧🇬Kazanlak, Bulgaria
UMHAT Kanev /ID# 233101
🇧🇬Ruse, Bulgaria
MHAT Targovishte /ID# 232942
🇧🇬Targovishte, Bulgaria
Duplicate_Chonbuk National University Hospital /ID# 232654
🇰🇷Jeonju, Korea, Republic of
Kazan State Medical University /ID# 233110
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
Indywidualna Specjalistyczna Praktyka Lekarska Filip Rybakowski /ID# 233170
🇵🇱Poznan, Slaskie, Poland
Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 232933
🇷🇺Orenburg, Russian Federation
Regional Clinical Psychiatry Hospital /ID# 232856
🇷🇺Saratov, Russian Federation
Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 232936
🇷🇺Saratov, Russian Federation
Ltd Clinic Hundred Years /ID# 232866
🇷🇺Tomsk, Russian Federation
University Clinical Center Serbia /ID# 233095
🇷🇸Belgrade, Beograd, Serbia
Clinical Centre Kragujevac /ID# 232874
🇷🇸Kragujevac, Serbia
Tri-Service General Hospital /ID# 233078
🇨🇳Taipei City, Taiwan
Taipei Tzu Chi Hospital /ID# 233128
🇨🇳New Taipei, Taiwan
Taipei Veterans General Hospital /ID# 232947
🇨🇳Taipei City, Taipei, Taiwan
National Cheng Kung University Hospital /ID# 233109
🇨🇳Tainan, Taiwan
Maharaj Nakorn Chiang Mai Hospital /ID# 232860
🇹🇭Chiang Mai, Thailand
Cherkasy regional psychiatric hospital of the CRC /ID# 232686
🇺🇦Smila, Cherkaska Oblast, Ukraine
Suan Prung Psychiatric Hospital /ID# 232862
🇹🇭Muang, Thailand
KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 232680
🇺🇦Uzhgorod, Zakarpatska Oblast, Ukraine
Odesa regional psychiatric hospital 2 of the ORC /ID# 232682
🇺🇦Oleksandrivka Village, Odeska Oblast, Ukraine
Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric /ID# 232876
🇺🇦Lviv, Ukraine
MNCE Odesa Regional Medical Center for Mental Health /ID# 232944
🇺🇦Odesa, Ukraine
Richard Weisler MD, PA & Assoc /ID# 233049
🇺🇸Raleigh, North Carolina, United States
University of South Florida /ID# 233093
🇺🇸Tampa, Florida, United States