Clinical trial NCT03593213: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-07-20
Enrollment: 587
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: 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 4.5 milligram per day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia
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


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.

Primary outcomes:
measure: Time to First Relapse During Double-blind Treatment Period
timeFrame: Randomization (Week 18) to End of Treatment (Week 44)
Secondary outcomes:
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Pillar Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest, LLC
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Bellflower
country: United States
facility: CITrials - Bellflower
state: California
city: Cerritos
country: United States
facility: Synexus Clinical Research US, Inc.
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Costa Mesa
country: United States
facility: California Pharmaceutical Research Institute, Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research Network, LLC.
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: La Habra
country: United States
facility: Omega Clinical Trials
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Long Beach
country: United States
facility: Alliance Research
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: Orange
country: United States
facility: Orange County Neuropsychiatric Research Center, LLC
state: California
city: Pico Rivera
country: United States
facility: CNRI-Los Angeles
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Hallandale Beach
country: United States
facility: Wilks & Safirstein MD PA D/B/A MD Clinical
state: Florida
city: Hialeah
country: United States
facility: Southern Winds Hospital
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research, Inc
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta LLC
state: Georgia
city: Dunwoody
country: United States
facility: Atlanta Behavioral Research, LLC
state: Georgia
city: Hoffman Estates
country: United States
facility: AMITA Health Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Shreveport
country: United States
facility: Louisiana Clinical Research
state: Louisiana
city: Gaithersburg
country: United States
facility: CBH Health LLC
state: Maryland
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Las Vegas
country: United States
facility: Alea Research Institute
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd.
state: Ohio
city: Columbus
country: United States
facility: OSY Psychiatry Department
state: Ohio
city: Mason
country: United States
facility: Professional Psychiatric Services
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research
state: Texas
city: Richardson
country: United States
facility: Pillar Healthcare
state: Texas
city: Burgas
country: Bulgaria
facility: Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas
city: Kardzhali
country: Bulgaria
facility: State Psychiatry Hospital
city: Kazanlak
country: Bulgaria
facility: MHAT Dr. Hristo Stambolski" EOOD; Department of Psychiatry
city: Lovech
country: Bulgaria
facility: State Psyciiatric Hospital - Lovech
city: Pleven
country: Bulgaria
facility: UMHAT Dr. Georgi Stranski, EAD
city: Ruse
country: Bulgaria
facility: Mental health Centre-Ruse EOOD
city: Targovishte
country: Bulgaria
facility: MHAT-Targovishte, AD
city: Varna
country: Bulgaria
facility: DCC Mladost M - Varna, OOD
city: Veliko Tarnovo
country: Bulgaria
facility: Mental Health Center - Veliko Tarnovo EOOD, Veliko Tarnovo
city: Vratsa
country: Bulgaria
facility: Mental Health Center - Vratsa EOOD, Vratsa
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Heaundae Paik Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Ipoh
country: Malaysia
facility: University Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
city: Kuching
country: Malaysia
facility: Hospital Sentosa
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr.1 im. Dr. A. Jurasza, Klinika Psychiatrii
city: Chełmno
country: Poland
facility: Samodzielny Publiczny Zespół Opieki Zdrowotnej
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House
city: Lublin
country: Poland
facility: Specjalistyczna Praktyka lekarska
city: Poznan
country: Poland
facility: Indywidualna Specjalistyczna Praktyka
city: San Juan
country: Puerto Rico
facility: INSPIRA Clinical Research
city: Brasov
country: Romania
facility: Spitalul de Psihiatrie si Neurologie Brasov
city: Bucharest
country: Romania
facility: Armys Clinical Emergency Central Hospital Prof Dr Carol Davila
city: București
country: Romania
facility: Spitalul de Psihiatrie TITAN "Dr. Constantin Gorgoș", Bulevardul Nicolae Grigorescu, Nr. 41
city: București
country: Romania
facility: CETTT SF Stelian Hospital
city: Targu Mures
country: Romania
facility: Spital Clinic Judetean Tg. Mures
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dr. Dragisa Misovic-Dedinje
city: Belgrade
country: Serbia
facility: Institute of Mental Health
city: Kovin
country: Serbia
facility: Special Hospital for Psychiatric Diseases "Kovin"
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac
city: Kragujevac
country: Serbia
facility: Clinical Centre Kragujevac
city: Novi Knezevac
country: Serbia
facility: Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
city: Novi Sad
country: Serbia
facility: Clinic for Psychiatry, Clinical Centre of Vojvodina
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: Department of Psychiatry, Taipei Veterans General Hospital, Taiwan
city: Mueang Nonthaburi
country: Thailand
facility: Suan prung Psychiatric Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Psychonevrological Hospital #3
city: Kharkiv
country: Ukraine
facility: Kharkiv regional clinical psychiatric hospital #3
city: Kharkiv
country: Ukraine
facility: Institute of Neurology, Psychiatry and Narcology of the NAMS of Ukraine
city: Kharkiv
country: Ukraine
facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrainian Railway"v
city: Kyiv
country: Ukraine
facility: Kyiv Regional Medical Incorporation "Psychiatry"
city: Kyiv
country: Ukraine
facility: Geikivka multidisciplinary hospital for psychiatric care
city: Lviv
country: Ukraine
facility: KNP of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
city: Odesa
country: Ukraine
facility: Odessa Regional Medical Centre of Mental Health
city: Odesa
country: Ukraine
facility: Odesa Regional Psychiatric Hospital No.2 of the ORC
city: Petrivka
country: Ukraine
facility: Kherson Regional Psychiatric Institution for Psychiatric Care
city: Smila
country: Ukraine
facility: Cherkasy regional psychiatric hospital of the CRC
city: Vinnytsia
country: Ukraine
facility: CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU
city: Vinnytsia
country: Ukraine
facility: VNMU
Study officials:
References: