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NCT03573297 Clinical Trial

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

Depression Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03573297
Other study ID # RGH-MD-25
Secondary ID 2017-000803-25
Status Completed
Phase Phase 3
First received
Last updated
Start date June 15, 2018
Est. completion date September 5, 2022

Study information
Verified date September 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 901
Est. completion date September 5, 2022
Est. primary completion date September 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cariprazine
Cariprazine capsules, oral administration, once daily
• Placebo
Matching placebo capsules, oral administration, once daily

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

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Bulgaria,  Korea, Republic of,  Malaysia,  Poland,  Puerto Rico,  Russian Federation,  Serbia,  Taiwan,  Thailand,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period 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
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