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

September 27, 2023 updated by: AbbVie

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/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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

901

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8001
        • Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas /ID# 232777
      • Kardzhali, Bulgaria, 6600
        • State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 232779
      • Kazanlak, Bulgaria, 6100
        • MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 232893
      • Lovech, Bulgaria, 5500
        • State Psychiatric Hospital - Lovech /ID# 232771
      • Pleven, Bulgaria, 5800
        • Second Psychiatric Clinic for General Psychiatry and Addictions of UMHAT Dr. Geo /ID# 232773
      • Pleven, Bulgaria, 5800
        • UMHAT Dr Georgi Stranski EAD /ID# 233105
      • Ruse, Bulgaria, 7002
        • UMHAT Kanev /ID# 233101
      • Sofia, Bulgaria, 1431
        • Clinic of Child Psychiatry St Nicolas /ID# 232925
      • Targovishte, Bulgaria, 7700
        • MHAT Targovishte /ID# 232942
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital /ID# 233097
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Hospital /ID# 233141
      • Gwangju, Korea, Republic of, 61469
        • Chonnam National University Hospital /ID# 233098
      • Jeju, Korea, Republic of, 63238
        • Jeju National University Hospital /ID# 233104
      • Jeonju, Korea, Republic of, 54907
        • Duplicate_Chonbuk National University Hospital /ID# 232654
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Med Ctr /ID# 233108
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Hospital Raja Permaisuri Bainun /ID# 233114
  • Poland
      • Chelmno, Poland, 86-200
        • Poradnia Zdrowia Psychicznego /ID# 232878
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-582
        • Specjalistyczny Gabinet Lekarski /ID# 232702
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 232848
    • Slaskie
      • Poznan, Slaskie, Poland, 60-744
        • Indywidualna Specjalistyczna Praktyka Lekarska Filip Rybakowski /ID# 233170
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • INSPIRA Clinical Research /ID# 232704
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • Mental Health Research Centre /ID# 232864
      • Nizhny Novgorod, Russian Federation, 603155
        • Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 232946
      • Orenburg, Russian Federation, 460006
        • Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 232933
      • Roschino, Russian Federation, 188820
        • State Public Institution of Healthcare Leningrad Regional Psychoneurology Dispen /ID# 232872
      • Saint Petersburg, Russian Federation, 197341
        • I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 232930
      • Saint-Petersburg, Russian Federation, 190121
        • St. Nicolas Psychiatric Hospital /ID# 232858
      • Saint-Petersburg, Russian Federation, 190121
        • St. Nicolas Psychiatric Hospital /ID# 232859
      • Saratov, Russian Federation, 410028
        • Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 232936
      • Saratov, Russian Federation, 410060
        • Regional Clinical Psychiatry Hospital /ID# 232856
      • St. Petersburg, Russian Federation, 192019
        • National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232927
      • St. Petersburg, Russian Federation, 192019
        • National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232928
      • Tomsk, Russian Federation, 634009
        • Ltd Clinic Hundred Years /ID# 232866
      • Tonnelniy, Russian Federation, 357034
        • Region Specialized Psychiatric Hospital #2 /ID# 232850
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420012
        • Kazan State Medical University /ID# 233110
  • Serbia
      • Belgrade, Serbia, 11040
        • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 232641
      • Belgrade, Serbia, 11108
        • Institute of Mental Health /ID# 232958
      • Kovin, Serbia, 26220
        • Special Hospital for Psychiatric Diseases Kovin /ID# 232829
      • Kragujevac, Serbia, 34000
        • Clinical Centre Kragujevac /ID# 232874
      • Novi Knezevac, Serbia, 23330
        • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 232846
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • University Clinical Center Serbia /ID# 233095
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • University Clinical Center Kragujevac /ID# 233096
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Clinical Center Vojvodina /ID# 233038
  • Taiwan
      • New Taipei, Taiwan, 23142
        • Taipei Tzu Chi Hospital /ID# 233128
      • Taichung City, Taiwan, 40447
        • China Medical University Hospital /ID# 233091
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital /ID# 233109
      • Taipei City, Taiwan, 11490
        • Tri-Service General Hospital /ID# 233078
    • Taipei
      • Taipei City, Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital /ID# 232947
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital /ID# 232860
      • Muang, Thailand, 50100
        • Suan Prung Psychiatric Hospital /ID# 232862
  • Ukraine
      • Lviv, Ukraine, 79021
        • Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric /ID# 232876
      • Odesa, Ukraine, 65006
        • MNCE Odesa Regional Medical Center for Mental Health /ID# 232944
      • Vinnytsia, Ukraine, 21005
        • CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU /ID# 232853
      • Vinnytsia, Ukraine, 21005
        • Vinnytsia Regional Psycho-Neurological Hospital /ID# 232852
    • Cherkaska Oblast
      • Smila, Cherkaska Oblast, Ukraine, 20708
        • Cherkasy regional psychiatric hospital of the CRC /ID# 232686
    • Dnipropetrovska Oblast
      • Kryvbas Village, Dnipropetrovska Oblast, Ukraine, 53054
        • Geikivka multidisciplinary hospital for psychiatric care /ID# 232678
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61068
        • SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232937
      • Kharkiv, Kharkivska Oblast, Ukraine, 61068
        • SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232938
      • Kharkiv, Kharkivska Oblast, Ukraine, 61068
        • SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232939
    • Khersonska Oblast
      • Stepanivka Village, Khersonska Oblast, Ukraine, 73488
        • Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 232684
    • Odeska Oblast
      • Oleksandrivka Village, Odeska Oblast, Ukraine, 67513
        • Odesa regional psychiatric hospital 2 of the ORC /ID# 232682
    • Zakarpatska Oblast
      • Uzhgorod, Zakarpatska Oblast, Ukraine, 88000
        • KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 232680
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group /ID# 232932
      • Rogers, Arkansas, United States, 72758-6442
        • Woodland Research Northwest, LLC /ID# 232982
    • California
      • Anaheim, California, United States, 92804
        • California Pharmaceutical Research Institute Inc. /ID# 232745
      • Anaheim, California, United States, 92805
        • Advanced Research Center /ID# 233120
      • Bellflower, California, United States, 90706-7079
        • CI Trials /ID# 232642
      • Cerritos, California, United States, 90703
        • Synexus Clinical Research US Inc. /ID# 232743
      • Costa Mesa, California, United States, 92626-4607
        • ATP Clinical Research, Inc /ID# 232979
      • Culver City, California, United States, 90230-6632
        • ProScience Research Group /ID# 232945
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Research - Orange County /ID# 233077
      • Glendale, California, United States, 91206-4261
        • Behavioral Research Specialists, LLC /ID# 232980
      • La Habra, California, United States, 90631-3842
        • Omega Clinical Trials LLC /ID# 233150
      • Lemon Grove, California, United States, 91945-2956
        • Synergy San Diego /ID# 232740
      • Long Beach, California, United States, 90807
        • Alliance for Research - Long Beach /ID# 232926
      • Orange, California, United States, 92868
        • NRC Research Institute /ID# 232741
      • San Diego, California, United States, 92102
        • CNRI-San Diego /ID# 232748
      • San Marcos, California, United States, 92078-2338
        • Artemis Institute for Clinical Research /ID# 233151
      • San Marcos, California, United States, 92078-2338
        • Artemis Institute for Clinical Research /ID# 233152
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Research LLC /ID# 232750
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Duplicate_MCB Clinical Research Centers LLC /ID# 232838
    • Florida
      • Hallandale Beach, Florida, United States, 33009-4427
        • Velocity Clinical Research - Hallandale Beach /ID# 232647
      • Hollywood, Florida, United States, 33024-2706
        • Research Centers of America - Hollywood FL /ID# 232649
      • Jacksonville, Florida, United States, 32256-6039
        • CNS Healthcare - Jacksonville /ID# 233160
      • Maitland, Florida, United States, 32751
        • Meridien Research /ID# 232941
      • Miami Lakes, Florida, United States, 33016
        • Miami Lakes Medical Research /ID# 232826
      • Tampa, Florida, United States, 33612
        • University of South Florida /ID# 233093
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Synexus Clinical Research, Inc /ID# 232950
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research /ID# 232832
      • Decatur, Georgia, United States, 30030
        • CenExcel iResearch LLC /ID# 233045
      • Dunwoody, Georgia, United States, 30338
        • Atlanta Behavioral Research, LLC /ID# 232935
    • Illinois
      • Winfield, Illinois, United States, 60190
        • NeuroPsychiatric Research Practice & Associate LTD /ID# 232840
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Louisiana Clinical Research /ID# 232685
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health LLC /ID# 232699
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • St. Charles Psychiatric Associates - Midwest Research Group /ID# 232709
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Duplicate_Altea Research Institute /ID# 232784
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute /ID# 233088
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research Inc /ID# 232791
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • New Hope Clinical Research Inc. /ID# 232716
      • Raleigh, North Carolina, United States, 27609
        • Richard Weisler MD, PA & Assoc /ID# 233049
    • Ohio
      • Beavercreek, Ohio, United States, 45431-2573
        • Clinical Inquest Center Ltd /ID# 233043
      • Columbus, Ohio, United States, 43210
        • DUPLICATE_The Ohios State University Department of Psychiatry /ID# 232739
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center /ID# 232737
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research /ID# 232931
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research Inc. /ID# 232672
      • Richardson, Texas, United States, 75080
        • Pillar Clinical Research LLC /ID# 232667
      • Richardson, Texas, United States, 75080
        • Pillar Clinical Research LLC /ID# 232673
      • The Woodlands, Texas, United States, 77381
        • Family Psychiatry of The Woodlands /ID# 232943

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double-Blind Cariprazine 3.0 mg/day
Participants randomized to receive cariprazine 3.0 mg once daily (QD) for up to 39 weeks.
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily
Experimental: Double-Blind Cariprazine 1.5 mg/day
Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily
Placebo Comparator: Double-Blind Placebo
Participants randomized to receive placebo QD for up to 39 weeks.
Drug: Placebo
Matching placebo capsules, oral administration, once daily
Experimental: Open Label Treatment
Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period
Time Frame: 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.
From Week 16 to Week 55

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

September 5, 2022

Study Completion (Actual)

September 5, 2022

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 27, 2018

First Posted (Actual)

June 29, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-25
  • 2017-000803-25 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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