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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

Primary Purpose

Bipolar I Disorder, Mania, Depression

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar I Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder, current episode manic, with or without mixed features;
  • A total YMRS score ≥ 20 and a score of at least 4 on 2 of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior, or bipolar I disorder, current episode depressive, with or without mixed features;
  • Having a MADRS total score ≥ 23 and a score of at least 3 on 2 of the following 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.

Sites / Locations

  • Woodland International Research Group /ID# 232932
  • Woodland Research Northwest, LLC /ID# 232982
  • California Pharmaceutical Research Institute Inc. /ID# 232745
  • Advanced Research Center /ID# 233120
  • CI Trials /ID# 232642
  • Synexus Clinical Research US Inc. /ID# 232743
  • ATP Clinical Research, Inc /ID# 232979
  • ProScience Research Group /ID# 232945
  • Collaborative Neuroscience Research - Orange County /ID# 233077
  • Behavioral Research Specialists, LLC /ID# 232980
  • Omega Clinical Trials LLC /ID# 233150
  • Synergy San Diego /ID# 232740
  • Alliance for Research - Long Beach /ID# 232926
  • NRC Research Institute /ID# 232741
  • CNRI-San Diego /ID# 232748
  • Artemis Institute for Clinical Research /ID# 233151
  • Artemis Institute for Clinical Research /ID# 233152
  • Collaborative Neuroscience Research LLC /ID# 232750
  • Duplicate_MCB Clinical Research Centers LLC /ID# 232838
  • Velocity Clinical Research - Hallandale Beach /ID# 232647
  • Research Centers of America - Hollywood FL /ID# 232649
  • CNS Healthcare - Jacksonville /ID# 233160
  • Meridien Research /ID# 232941
  • Miami Lakes Medical Research /ID# 232826
  • University of South Florida /ID# 233093
  • Synexus Clinical Research, Inc /ID# 232950
  • Atlanta Center for Medical Research /ID# 232832
  • CenExcel iResearch LLC /ID# 233045
  • Atlanta Behavioral Research, LLC /ID# 232935
  • NeuroPsychiatric Research Practice & Associate LTD /ID# 232840
  • Louisiana Clinical Research /ID# 232685
  • CBH Health LLC /ID# 232699
  • St. Charles Psychiatric Associates - Midwest Research Group /ID# 232709
  • Duplicate_Altea Research Institute /ID# 232784
  • Hassman Research Institute /ID# 233088
  • Neurobehavioral Research Inc /ID# 232791
  • New Hope Clinical Research Inc. /ID# 232716
  • Richard Weisler MD, PA & Assoc /ID# 233049
  • Clinical Inquest Center Ltd /ID# 233043
  • DUPLICATE_The Ohios State University Department of Psychiatry /ID# 232739
  • Midwest Clinical Research Center /ID# 232737
  • Sooner Clinical Research /ID# 232931
  • Community Clinical Research Inc. /ID# 232672
  • Pillar Clinical Research LLC /ID# 232667
  • Pillar Clinical Research LLC /ID# 232673
  • Family Psychiatry of The Woodlands /ID# 232943
  • Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas /ID# 232777
  • State Psychiatry Hospital-Kardzhali; Third Male Department /ID# 232779
  • MHAT Dr. Hristo Stambolski EOOD; Hospital Pharmacy /ID# 232893
  • State Psychiatric Hospital - Lovech /ID# 232771
  • Second Psychiatric Clinic for General Psychiatry and Addictions of UMHAT Dr. Geo /ID# 232773
  • UMHAT Dr Georgi Stranski EAD /ID# 233105
  • UMHAT Kanev /ID# 233101
  • Clinic of Child Psychiatry St Nicolas /ID# 232925
  • MHAT Targovishte /ID# 232942
  • Inje University Busan Paik Hospital /ID# 233097
  • Inje University Haeundae Hospital /ID# 233141
  • Chonnam National University Hospital /ID# 233098
  • Jeju National University Hospital /ID# 233104
  • Duplicate_Chonbuk National University Hospital /ID# 232654
  • Hospital Raja Permaisuri Bainun /ID# 233114
  • University Malaya Med Ctr /ID# 233108
  • Specjalistyczny Gabinet Lekarski /ID# 232702
  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 232848
  • Indywidualna Specjalistyczna Praktyka Lekarska Filip Rybakowski /ID# 233170
  • Poradnia Zdrowia Psychicznego /ID# 232878
  • INSPIRA Clinical Research /ID# 232704
  • Kazan State Medical University /ID# 233110
  • Mental Health Research Centre /ID# 232864
  • Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 232946
  • Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 232933
  • State Public Institution of Healthcare Leningrad Regional Psychoneurology Dispen /ID# 232872
  • I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 232930
  • St. Nicolas Psychiatric Hospital /ID# 232858
  • St. Nicolas Psychiatric Hospital /ID# 232859
  • Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 232936
  • Regional Clinical Psychiatry Hospital /ID# 232856
  • National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232927
  • National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 232928
  • Ltd Clinic Hundred Years /ID# 232866
  • Region Specialized Psychiatric Hospital #2 /ID# 232850
  • University Clinical Center Serbia /ID# 233095
  • University Clinical Center Kragujevac /ID# 233096
  • Clinical Center Vojvodina /ID# 233038
  • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 232641
  • Institute of Mental Health /ID# 232958
  • Special Hospital for Psychiatric Diseases Kovin /ID# 232829
  • Clinical Centre Kragujevac /ID# 232874
  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi /ID# 232846
  • Taipei Veterans General Hospital /ID# 232947
  • Taipei Tzu Chi Hospital /ID# 233128
  • China Medical University Hospital /ID# 233091
  • National Cheng Kung University Hospital /ID# 233109
  • Tri-Service General Hospital /ID# 233078
  • Maharaj Nakorn Chiang Mai Hospital /ID# 232860
  • Suan Prung Psychiatric Hospital /ID# 232862
  • Cherkasy regional psychiatric hospital of the CRC /ID# 232686
  • Geikivka multidisciplinary hospital for psychiatric care /ID# 232678
  • SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232937
  • SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232938
  • SI Institution Neurology Psychiatry and Narcology NAMS of Ukraine /ID# 232939
  • Kherson Regional Psychiatric Institution for Psychiatric Care /ID# 232684
  • Odesa regional psychiatric hospital 2 of the ORC /ID# 232682
  • KNP Zakarpatskyi Regional MC of Mental Health and Medicine of Dependencies /ID# 232680
  • Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric /ID# 232876
  • MNCE Odesa Regional Medical Center for Mental Health /ID# 232944
  • CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU /ID# 232853
  • Vinnytsia Regional Psycho-Neurological Hospital /ID# 232852

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Double-Blind Cariprazine 3.0 mg/day

Double-Blind Cariprazine 1.5 mg/day

Double-Blind Placebo

Open Label Treatment

Arm Description

Participants randomized to receive cariprazine 3.0 mg once daily (QD) for up to 39 weeks.

Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.

Participants randomized to receive placebo QD for up to 39 weeks.

Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2018
Last Updated
September 27, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03573297
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder, Mania, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
901 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double-Blind Cariprazine 3.0 mg/day
Arm Type
Experimental
Arm Description
Participants randomized to receive cariprazine 3.0 mg once daily (QD) for up to 39 weeks.
Arm Title
Double-Blind Cariprazine 1.5 mg/day
Arm Type
Experimental
Arm Description
Participants randomized to receive cariprazine 1.5 mg QD for up to 39 weeks.
Arm Title
Double-Blind Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to receive placebo QD for up to 39 weeks.
Arm Title
Open Label Treatment
Arm Type
Experimental
Arm Description
Participants started on cariprazine 1.5 mg QD, with a target dose of 3.0 mg QD, for up to 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Intervention Description
Cariprazine capsules, oral administration, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules, oral administration, once daily
Primary Outcome Measure Information:
Title
Time to First Relapse of Any Mood Episode During the Double-Blind Treatment Period
Description
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.
Time Frame
From Week 16 to Week 55

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
Related Info

Learn more about this 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

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