Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
NCT ID: NCT03593213
Last Updated: 2022-04-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
587 participants
INTERVENTIONAL
2018-07-30
2021-02-11
Brief Summary
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2. 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cariprazine 4.5 mg/day (Open-label Treatment Period)
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
Cariprazine capsules, oral administration, once daily.
Placebo (Double-blind Treatment Period)
Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Placebo
Matching placebo capsules, oral administration, once daily.
Cariprazine 3.0 mg/day (Double-blind Treatment Period)
Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Cariprazine
Cariprazine capsules, oral administration, once daily.
Cariprazine 4.5 mg/day (Double-blind Treatment Period)
Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Cariprazine
Cariprazine capsules, oral administration, once daily.
Interventions
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Cariprazine
Cariprazine capsules, oral administration, once daily.
Placebo
Matching placebo capsules, oral administration, once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
64 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Locations
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Pillar Clinical Research
Bentonville, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest, LLC
Rogers, Arkansas, United States
Advanced Research Center, Inc.
Anaheim, California, United States
CITrials - Bellflower
Bellflower, California, United States
Synexus Clinical Research US, Inc.
Cerritos, California, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
California Pharmaceutical Research Institute, Inc.
Costa Mesa, California, United States
ProScience Research Group
Culver City, California, United States
Collaborative Neuroscience Research Network, LLC.
Garden Grove, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
Omega Clinical Trials
La Habra, California, United States
Synergy San Diego
Lemon Grove, California, United States
Alliance Research
Long Beach, California, United States
Excell Research, Inc
Oceanside, California, United States
Orange County Neuropsychiatric Research Center, LLC
Orange, California, United States
CNRI-Los Angeles
Pico Rivera, California, United States
University of California San Diego
San Diego, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Collaborative Neuroscience Research, LLC
Torrance, California, United States
Wilks & Safirstein MD PA D/B/A MD Clinical
Hallandale, Florida, United States
Southern Winds Hospital
Hialeah, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Synexus Clinical Research, Inc
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
iResearch Atlanta LLC
Decatur, Georgia, United States
Atlanta Behavioral Research, LLC
Dunwoody, Georgia, United States
AMITA Health Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Louisiana Clinical Research
Shreveport, Louisiana, United States
CBH Health LLC
Gaithersburg, Maryland, United States
Altea Research
Las Vegas, Nevada, United States
Alea Research Institute
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Clinical Inquest Center Ltd.
Beavercreek, Ohio, United States
OSY Psychiatry Department
Columbus, Ohio, United States
Professional Psychiatric Services
Mason, Ohio, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Community Clinical Research, Inc.
Austin, Texas, United States
Pillar Clinical Research
Richardson, Texas, United States
Pillar Healthcare
Richardson, Texas, United States
Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas
Burgas, , Bulgaria
State Psychiatry Hospital
Kardzhali, , Bulgaria
MHAT Dr. Hristo Stambolski" EOOD; Department of Psychiatry
Kazanlak, , Bulgaria
State Psyciiatric Hospital - Lovech
Lovech, , Bulgaria
UMHAT Dr. Georgi Stranski, EAD
Pleven, , Bulgaria
Mental health Centre-Ruse EOOD
Rousse, , Bulgaria
MHAT-Targovishte, AD
Targovishte, , Bulgaria
DCC Mladost M - Varna, OOD
Varna, , Bulgaria
Mental Health Center - Veliko Tarnovo EOOD, Veliko Tarnovo
Veliko Tarnovo, , Bulgaria
Mental Health Center - Vratsa EOOD, Vratsa
Vratsa, , Bulgaria
University Kuala Lumpur
Ipoh, , Malaysia
University Malaya Medical Center
Kuala Lumpur, , Malaysia
Hospital Sentosa
Kuching, , Malaysia
Szpital Uniwersytecki Nr.1 im. Dr. A. Jurasza, Klinika Psychiatrii
Bydgoszcz, , Poland
Samodzielny Publiczny Zespół Opieki Zdrowotnej
Chełmno, , Poland
Centrum Badan Klinicznych PI-House
Gdansk, , Poland
Specjalistyczna Praktyka lekarska
Lublin, , Poland
Indywidualna Specjalistyczna Praktyka
Poznan, , Poland
INSPIRA Clinical Research
San Juan, , Puerto Rico
Spitalul de Psihiatrie si Neurologie Brasov
Brasov, , Romania
Spitalul de Psihiatrie TITAN "Dr. Constantin Gorgoș", Bulevardul Nicolae Grigorescu, Nr. 41
Bucharest, , Romania
Armys Clinical Emergency Central Hospital Prof Dr Carol Davila
Bucharest, , Romania
CETTT SF Stelian Hospital
Bucharest, , Romania
Spital Clinic Judetean Tg. Mures
Târgu Mureş, , Romania
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Hospital Center Dr. Dragisa Misovic-Dedinje
Belgrade, , Serbia
Institute of Mental Health
Belgrade, , Serbia
Special Hospital for Psychiatric Diseases "Kovin"
Kovin, , Serbia
Clinical Centre Kragujevac
Kragujevac, , Serbia
Clinical Centre Kragujevac
Kragujevac, , Serbia
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
Novi Kneževac, , Serbia
Clinic for Psychiatry, Clinical Centre of Vojvodina
Novi Sad, , Serbia
Inje University Busan Paik Hospital
Busan, , South Korea
Inje University Heaundae Paik Hospital
Busan, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Taipei Tzu Chi Hospital
New Taipei City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Department of Psychiatry, Taipei Veterans General Hospital, Taiwan
Taipei, , Taiwan
Suan prung Psychiatric Hospital
Nonthaburi, , Thailand
Regional Psychonevrological Hospital #3
Ivano-Frankivsk, , Ukraine
Kharkiv regional clinical psychiatric hospital #3
Kharkiv, , Ukraine
Institute of Neurology, Psychiatry and Narcology of the NAMS of Ukraine
Kharkiv, , Ukraine
SI Institute of Neurology, Psychiatry and Narcology of NAMSU
Kharkiv, , Ukraine
Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrainian Railway"v
Kyiv, , Ukraine
Kyiv Regional Medical Incorporation "Psychiatry"
Kyiv, , Ukraine
Geikivka multidisciplinary hospital for psychiatric care
Kyiv, , Ukraine
KNP of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
Lviv, , Ukraine
Odessa Regional Medical Centre of Mental Health
Odesa, , Ukraine
Odesa Regional Psychiatric Hospital No.2 of the ORC
Odesa, , Ukraine
Kherson Regional Psychiatric Institution for Psychiatric Care
Petrivka, , Ukraine
Cherkasy regional psychiatric hospital of the CRC
Smila, , Ukraine
CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU
Vinnytsia, , Ukraine
VNMU
Vinnytsia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-000818-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RGH-MD-24
Identifier Type: -
Identifier Source: org_study_id
NCT04519099
Identifier Type: -
Identifier Source: nct_alias
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