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Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia

Primary Purpose

Schizophrenia

Status
Terminated
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 Schizophrenia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
  • Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits.
  • Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
  • Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1).
  • Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.

Exclusion Criteria:

  • Currently meeting DSM-5 criteria for any of the following:
  • Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
  • Bipolar I and II disorder
  • Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
  • History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1.
  • Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
  • Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.

Sites / Locations

  • Pillar Clinical Research
  • Woodland International Research Group
  • Woodland Research Northwest, LLC
  • Advanced Research Center, Inc.
  • CITrials - Bellflower
  • Synexus Clinical Research US, Inc.
  • ATP Clinical Research, Inc.
  • California Pharmaceutical Research Institute, Inc.
  • ProScience Research Group
  • Collaborative Neuroscience Research Network, LLC.
  • Behavioral Research Specialists, LLC
  • Omega Clinical Trials
  • Synergy San Diego
  • Alliance Research
  • Excell Research, Inc
  • Orange County Neuropsychiatric Research Center, LLC
  • CNRI-Los Angeles
  • University of California San Diego
  • Schuster Medical Research Institute
  • Collaborative Neuroscience Research, LLC
  • Wilks & Safirstein MD PA D/B/A MD Clinical
  • Southern Winds Hospital
  • Research Centers of America
  • Synexus Clinical Research, Inc
  • Atlanta Center for Medical Research
  • iResearch Atlanta LLC
  • Atlanta Behavioral Research, LLC
  • AMITA Health Alexian Brothers Center for Psychiatric Research
  • Louisiana Clinical Research
  • CBH Health LLC
  • Altea Research
  • Alea Research Institute
  • Hassman Research Institute
  • Neurobehavioral Research, Inc.
  • New Hope Clinical Research
  • Clinical Inquest Center Ltd.
  • OSY Psychiatry Department
  • Professional Psychiatric Services
  • Sooner Clinical Research
  • Community Clinical Research, Inc.
  • Pillar Clinical Research
  • Pillar Healthcare
  • Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas
  • State Psychiatry Hospital
  • MHAT Dr. Hristo Stambolski" EOOD; Department of Psychiatry
  • State Psyciiatric Hospital - Lovech
  • UMHAT Dr. Georgi Stranski, EAD
  • Mental health Centre-Ruse EOOD
  • MHAT-Targovishte, AD
  • DCC Mladost M - Varna, OOD
  • Mental Health Center - Veliko Tarnovo EOOD, Veliko Tarnovo
  • Mental Health Center - Vratsa EOOD, Vratsa
  • Inje University Busan Paik Hospital
  • Inje University Heaundae Paik Hospital
  • Chonnam National University Hospital
  • Gachon University Gil Medical Center
  • Jeju National University Hospital
  • University Kuala Lumpur
  • University Malaya Medical Center
  • Hospital Sentosa
  • Szpital Uniwersytecki Nr.1 im. Dr. A. Jurasza, Klinika Psychiatrii
  • Samodzielny Publiczny Zespół Opieki Zdrowotnej
  • Centrum Badan Klinicznych PI-House
  • Specjalistyczna Praktyka lekarska
  • Indywidualna Specjalistyczna Praktyka
  • INSPIRA Clinical Research
  • Spitalul de Psihiatrie si Neurologie Brasov
  • Armys Clinical Emergency Central Hospital Prof Dr Carol Davila
  • Spitalul de Psihiatrie TITAN "Dr. Constantin Gorgoș", Bulevardul Nicolae Grigorescu, Nr. 41
  • CETTT SF Stelian Hospital
  • Spital Clinic Judetean Tg. Mures
  • Clinical Center of Serbia
  • Clinical Hospital Center Dr. Dragisa Misovic-Dedinje
  • Institute of Mental Health
  • Special Hospital for Psychiatric Diseases "Kovin"
  • Clinical Centre Kragujevac
  • Clinical Centre Kragujevac
  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
  • Clinic for Psychiatry, Clinical Centre of Vojvodina
  • Taipei Tzu Chi Hospital
  • National Cheng Kung University Hospital
  • Department of Psychiatry, Taipei Veterans General Hospital, Taiwan
  • Suan prung Psychiatric Hospital
  • Regional Psychonevrological Hospital #3
  • Kharkiv regional clinical psychiatric hospital #3
  • Institute of Neurology, Psychiatry and Narcology of the NAMS of Ukraine
  • SI Institute of Neurology, Psychiatry and Narcology of NAMSU
  • Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrainian Railway"v
  • Kyiv Regional Medical Incorporation "Psychiatry"
  • Geikivka multidisciplinary hospital for psychiatric care
  • KNP of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
  • Odessa Regional Medical Centre of Mental Health
  • Odesa Regional Psychiatric Hospital No.2 of the ORC
  • Kherson Regional Psychiatric Institution for Psychiatric Care
  • Cherkasy regional psychiatric hospital of the CRC
  • CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU
  • VNMU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Cariprazine 4.5 mg/day (Open-label Treatment Period)

Placebo (Double-blind Treatment Period)

Cariprazine 3.0 mg/day (Double-blind Treatment Period)

Cariprazine 4.5 mg/day (Double-blind Treatment Period)

Arm Description

Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.

Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Outcomes

Primary Outcome Measures

Time to First Relapse During Double-blind Treatment Period
Time to Relapse is the number of days from randomization to first relapse. Relapse is defined as any 1 of the following: Increase in Positive and Negative Syndrome Scale(PANSS) by ≥30% for participants who had total score of ≥50 at randomization or ≥10-point increased score with total score <50 at randomization [PANSS=30 questions where 1=absence of symptoms to 7=extremely severe symptom;total score=30 to 210;higher score more severe symptoms] Increase in Clinical Global Impression-Severity (CGI-S) score by 2 or more points [1=normal to 7=among most extremely ill] Score of >4 on 1 or more of 7 PANSS items:P1-delusions,P2-conceptual disorganization,P3-hallucinatory behavior,P6-suspiciousness,P7-hostility,G8-uncooperativeness,G14-poor impulse control Deliberate self-injury Initiation of treatment with mood stabilizer,antidepressant,antipsychotics or benzodiazepine that exceeds specified allowance Psychiatric hospitalization Exacerbation of psychiatric illness

Secondary Outcome Measures

Full Information

First Posted
July 10, 2018
Last Updated
April 7, 2022
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03593213
Brief Title
Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
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 Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
FDA Released Allergan from this post marketing requirement
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
587 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cariprazine 4.5 mg/day (Open-label Treatment Period)
Arm Type
Experimental
Arm Description
Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.
Arm Title
Placebo (Double-blind Treatment Period)
Arm Type
Placebo Comparator
Arm Description
Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Arm Title
Cariprazine 3.0 mg/day (Double-blind Treatment Period)
Arm Type
Experimental
Arm Description
Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Arm Title
Cariprazine 4.5 mg/day (Double-blind Treatment Period)
Arm Type
Experimental
Arm Description
Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
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 During Double-blind Treatment Period
Description
Time to Relapse is the number of days from randomization to first relapse. Relapse is defined as any 1 of the following: Increase in Positive and Negative Syndrome Scale(PANSS) by ≥30% for participants who had total score of ≥50 at randomization or ≥10-point increased score with total score <50 at randomization [PANSS=30 questions where 1=absence of symptoms to 7=extremely severe symptom;total score=30 to 210;higher score more severe symptoms] Increase in Clinical Global Impression-Severity (CGI-S) score by 2 or more points [1=normal to 7=among most extremely ill] Score of >4 on 1 or more of 7 PANSS items:P1-delusions,P2-conceptual disorganization,P3-hallucinatory behavior,P6-suspiciousness,P7-hostility,G8-uncooperativeness,G14-poor impulse control Deliberate self-injury Initiation of treatment with mood stabilizer,antidepressant,antipsychotics or benzodiazepine that exceeds specified allowance Psychiatric hospitalization Exacerbation of psychiatric illness
Time Frame
Randomization (Week 18) to End of Treatment (Week 44)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening). Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits. Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5). Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1). Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2. Exclusion Criteria: Currently meeting DSM-5 criteria for any of the following: Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders Bipolar I and II disorder Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit 1. Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study. Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.
Facility Information:
Facility Name
Pillar Clinical Research
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest, LLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
CITrials - Bellflower
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
California Pharmaceutical Research Institute, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Collaborative Neuroscience Research Network, LLC.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Omega Clinical Trials
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Alliance Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Excell Research, Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Orange County Neuropsychiatric Research Center, LLC
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
CNRI-Los Angeles
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8229
Country
United States
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91423
Country
United States
Facility Name
Collaborative Neuroscience Research, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Wilks & Safirstein MD PA D/B/A MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Southern Winds Hospital
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Synexus Clinical Research, Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
iResearch Atlanta LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Atlanta Behavioral Research, LLC
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
AMITA Health Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Louisiana Clinical Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
CBH Health LLC
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Altea Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
85012
Country
United States
Facility Name
Alea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Clinical Inquest Center Ltd.
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Facility Name
OSY Psychiatry Department
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Professional Psychiatric Services
City
Mason
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
23112
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Pillar Clinical Research
City
Richardson
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
Facility Name
Pillar Healthcare
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
State Psychiatry Hospital
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Facility Name
MHAT Dr. Hristo Stambolski" EOOD; Department of Psychiatry
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
State Psyciiatric Hospital - Lovech
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Facility Name
UMHAT Dr. Georgi Stranski, EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Mental health Centre-Ruse EOOD
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
MHAT-Targovishte, AD
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Facility Name
DCC Mladost M - Varna, OOD
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Mental Health Center - Veliko Tarnovo EOOD, Veliko Tarnovo
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Mental Health Center - Vratsa EOOD, Vratsa
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Inje University Heaundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
ZIP/Postal Code
63241
Country
Korea, Republic of
Facility Name
University Kuala Lumpur
City
Ipoh
ZIP/Postal Code
30450
Country
Malaysia
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Sentosa
City
Kuching
ZIP/Postal Code
93250
Country
Malaysia
Facility Name
Szpital Uniwersytecki Nr.1 im. Dr. A. Jurasza, Klinika Psychiatrii
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Samodzielny Publiczny Zespół Opieki Zdrowotnej
City
Chełmno
ZIP/Postal Code
86-200
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Specjalistyczna Praktyka lekarska
City
Lublin
ZIP/Postal Code
20-589
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka
City
Poznan
ZIP/Postal Code
60744
Country
Poland
Facility Name
INSPIRA Clinical Research
City
San Juan
ZIP/Postal Code
918
Country
Puerto Rico
Facility Name
Spitalul de Psihiatrie si Neurologie Brasov
City
Brasov
ZIP/Postal Code
500079
Country
Romania
Facility Name
Armys Clinical Emergency Central Hospital Prof Dr Carol Davila
City
Bucharest
ZIP/Postal Code
60011
Country
Romania
Facility Name
Spitalul de Psihiatrie TITAN "Dr. Constantin Gorgoș", Bulevardul Nicolae Grigorescu, Nr. 41
City
București
ZIP/Postal Code
30447
Country
Romania
Facility Name
CETTT SF Stelian Hospital
City
București
ZIP/Postal Code
60222
Country
Romania
Facility Name
Spital Clinic Judetean Tg. Mures
City
Targu Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Dr. Dragisa Misovic-Dedinje
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Mental Health
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Special Hospital for Psychiatric Diseases "Kovin"
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Facility Name
Clinical Centre Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Centre Kragujevac
City
Kragujevac
ZIP/Postal Code
3400
Country
Serbia
Facility Name
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
City
Novi Knezevac
ZIP/Postal Code
23330
Country
Serbia
Facility Name
Clinic for Psychiatry, Clinical Centre of Vojvodina
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Taipei Tzu Chi Hospital
City
New Taipei City
ZIP/Postal Code
23142
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan City
ZIP/Postal Code
70428
Country
Taiwan
Facility Name
Department of Psychiatry, Taipei Veterans General Hospital, Taiwan
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Suan prung Psychiatric Hospital
City
Mueang Nonthaburi
ZIP/Postal Code
50100
Country
Thailand
Facility Name
Regional Psychonevrological Hospital #3
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Kharkiv regional clinical psychiatric hospital #3
City
Kharkiv
ZIP/Postal Code
31068
Country
Ukraine
Facility Name
Institute of Neurology, Psychiatry and Narcology of the NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
SI Institute of Neurology, Psychiatry and Narcology of NAMSU
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrainian Railway"v
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Kyiv Regional Medical Incorporation "Psychiatry"
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Geikivka multidisciplinary hospital for psychiatric care
City
Kyiv
ZIP/Postal Code
53054
Country
Ukraine
Facility Name
KNP of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Odessa Regional Medical Centre of Mental Health
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Odesa Regional Psychiatric Hospital No.2 of the ORC
City
Odesa
ZIP/Postal Code
67513
Country
Ukraine
Facility Name
Kherson Regional Psychiatric Institution for Psychiatric Care
City
Petrivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Cherkasy regional psychiatric hospital of the CRC
City
Smila
ZIP/Postal Code
20704
Country
Ukraine
Facility Name
CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
VNMU
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 and 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, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia

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