Clinical trial NCT03573297: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Mania
Depression
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-06-29
Enrollment: 901
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period
timeFrame: From Week 16 to Week 55
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group /ID# 232932
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest, LLC /ID# 232982
state: Arkansas
city: Anaheim
country: United States
facility: California Pharmaceutical Research Institute Inc. /ID# 232745
state: California
city: Anaheim
country: United States
facility: Advanced Research Center /ID# 233120
state: California
city: Bellflower
country: United States
facility: CI Trials /ID# 232642
state: California
city: Cerritos
country: United States
facility: Synexus Clinical Research US Inc. /ID# 232743
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc /ID# 232979
state: California
city: Culver City
country: United States
facility: ProScience Research Group /ID# 232945
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research - Orange County /ID# 233077
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC /ID# 232980
state: California
city: La Habra
country: United States
facility: Omega Clinical Trials LLC /ID# 233150
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego /ID# 232740
state: California
city: Long Beach
country: United States
facility: Alliance for Research - Long Beach /ID# 232926
state: California
city: Orange
country: United States
facility: NRC Research Institute /ID# 232741
state: California
city: San Diego
country: United States
facility: CNRI-San Diego /ID# 232748
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research /ID# 233151
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research /ID# 233152
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research LLC /ID# 232750
state: California
city: Colorado Springs
country: United States
facility: Duplicate_MCB Clinical Research Centers LLC /ID# 232838
state: Colorado
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research - Hallandale Beach /ID# 232647
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America - Hollywood FL /ID# 232649
state: Florida
city: Jacksonville
country: United States
facility: CNS Healthcare - Jacksonville /ID# 233160
state: Florida
city: Maitland
country: United States
facility: Meridien Research /ID# 232941
state: Florida
city: Miami Lakes
country: United States
facility: Miami Lakes Medical Research /ID# 232826
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 233093
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research, Inc /ID# 232950
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research /ID# 232832
state: Georgia
city: Decatur
country: United States
facility: CenExcel iResearch LLC /ID# 233045
state: Georgia
city: Dunwoody
country: United States
facility: Atlanta Behavioral Research, LLC /ID# 232935
state: Georgia
city: Winfield
country: United States
facility: NeuroPsychiatric Research Practice & Associate LTD /ID# 232840
state: Illinois
city: Shreveport
country: United States
facility: Louisiana Clinical Research /ID# 232685
state: Louisiana
city: Gaithersburg
country: United States
facility: CBH Health LLC /ID# 232699
state: Maryland
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group /ID# 232709
state: Missouri
city: Las Vegas
country: United States
facility: Duplicate_Altea Research Institute /ID# 232784
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute /ID# 233088
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research Inc /ID# 232791
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research Inc. /ID# 232716
state: North Carolina
city: Raleigh
country: United States
facility: Richard Weisler MD, PA & Assoc /ID# 233049
state: North Carolina
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd /ID# 233043
state: Ohio
city: Columbus
country: United States
facility: DUPLICATE_The Ohios State University Department of Psychiatry /ID# 232739
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center /ID# 232737
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research /ID# 232931
state: Oklahoma
city: Austin
country: United States
facility: Community Clinical Research Inc. /ID# 232672
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research LLC /ID# 232667
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research LLC /ID# 232673
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands /ID# 232943
state: Texas
city: Burgas
country: Bulgaria
facility: Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas /ID# 232777
city: Kardzhali
country: Bulgaria
facility: State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 232779
city: Kazanlak
country: Bulgaria
facility: MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 232893
city: Lovech
country: Bulgaria
facility: State Psychiatric Hospital - Lovech /ID# 232771
city: Pleven
country: Bulgaria
facility: Second Psychiatric Clinic for General Psychiatry and Addictions of UMHAT Dr. Geo /ID# 232773
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski EAD /ID# 233105
city: Ruse
country: Bulgaria
facility: UMHAT Kanev /ID# 233101
city: Sofia
country: Bulgaria
facility: Clinic of Child Psychiatry St Nicolas /ID# 232925
city: Targovishte
country: Bulgaria
facility: MHAT Targovishte /ID# 232942
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital /ID# 233097
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Hospital /ID# 233141
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital /ID# 233098
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital /ID# 233104
city: Jeonju
country: Korea, Republic of
facility: Duplicate_Chonbuk National University Hospital /ID# 232654
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun /ID# 233114
state: Perak
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Med Ctr /ID# 233108
city: Lublin
country: Poland
facility: Specjalistyczny Gabinet Lekarski /ID# 232702
state: Lubelskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 232848
state: Pomorskie
city: Poznan
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Filip Rybakowski /ID# 233170
state: Slaskie
city: Chelmno
country: Poland
facility: Poradnia Zdrowia Psychicznego /ID# 232878
city: San Juan
country: Puerto Rico
facility: INSPIRA Clinical Research /ID# 232704
city: Kazan
country: Russian Federation
facility: Kazan State Medical University /ID# 233110
state: Tatarstan, Respublika
city: Moscow
country: Russian Federation
facility: Mental Health Research Centre /ID# 232864
city: Nizhny Novgorod
country: Russian Federation
facility: Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 232946
city: Orenburg
country: Russian Federation
facility: Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 232933
city: Roschino
country: Russian Federation
facility: State Public Institution of Healthcare Leningrad Regional Psychoneurology Dispen /ID# 232872
city: Saint Petersburg
country: Russian Federation
facility: I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 232930
city: Saint-Petersburg
country: Russian Federation
facility: St. Nicolas Psychiatric Hospital /ID# 232858
city: Saint-Petersburg
country: Russian Federation
facility: St. Nicolas Psychiatric Hospital /ID# 232859
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 232936
city: Saratov
country: Russian Federation
facility: Regional Clinical Psychiatry Hospital /ID# 232856
city: St. Petersburg
country: Russian Federation
facility: National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232927
city: St. Petersburg
country: Russian Federation
facility: National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232928
city: Tomsk
country: Russian Federation
facility: Ltd Clinic Hundred Years /ID# 232866
city: Tonnelniy
country: Russian Federation
facility: Region Specialized Psychiatric Hospital #2 /ID# 232850
city: Belgrade
country: Serbia
facility: University Clinical Center Serbia /ID# 233095
state: Beograd
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac /ID# 233096
state: Sumadijski Okrug
city: Novi Sad
country: Serbia
facility: Clinical Center Vojvodina /ID# 233038
state: Vojvodina
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 232641
city: Belgrade
country: Serbia
facility: Institute of Mental Health /ID# 232958
city: Kovin
country: Serbia
facility: Special Hospital for Psychiatric Diseases Kovin /ID# 232829
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac /ID# 232874
city: Novi Knezevac
country: Serbia
facility: Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 232846
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital /ID# 232947
state: Taipei
city: New Taipei
country: Taiwan
facility: Taipei Tzu Chi Hospital /ID# 233128
city: Taichung City
country: Taiwan
facility: China Medical University Hospital /ID# 233091
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 233109
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital /ID# 233078
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital /ID# 232860
city: Muang
country: Thailand
facility: Suan Prung Psychiatric Hospital /ID# 232862
city: Smila
country: Ukraine
facility: Cherkasy regional psychiatric hospital of the CRC /ID# 232686
state: Cherkaska Oblast
city: Kryvbas Village
country: Ukraine
facility: Geikivka multidisciplinary hospital for psychiatric care /ID# 232678
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232937
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232938
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232939
state: Kharkivska Oblast
city: Stepanivka Village
country: Ukraine
facility: Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 232684
state: Khersonska Oblast
city: Oleksandrivka Village
country: Ukraine
facility: Odesa regional psychiatric hospital 2 of the ORC /ID# 232682
state: Odeska Oblast
city: Uzhgorod
country: Ukraine
facility: KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 232680
state: Zakarpatska Oblast
city: Lviv
country: Ukraine
facility: Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric /ID# 232876
city: Odesa
country: Ukraine
facility: MNCE Odesa Regional Medical Center for Mental Health /ID# 232944
city: Vinnytsia
country: Ukraine
facility: CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU /ID# 232853
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Psycho-Neurological Hospital /ID# 232852
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: