Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
- Registration Number
- NCT03593213
- Lead Sponsor
- AbbVie
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 587
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (Double-blind Treatment Period) Placebo Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period. Cariprazine 4.5 mg/day (Open-label Treatment Period) Cariprazine 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 3.0 mg/day (Double-blind Treatment Period) Cariprazine Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period. Cariprazine 4.5 mg/day (Double-blind Treatment Period) Cariprazine Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
- Primary Outcome Measures
Name Time Method Time to First Relapse During Double-blind Treatment Period Randomization (Week 18) to End of Treatment (Week 44) 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
Name Time Method
Trial Locations
- Locations (95)
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
California Pharmaceutical Research Institute, Inc.
🇺🇸Costa Mesa, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸Torrance, California, 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
OSY Psychiatry Department
🇺🇸Columbus, Ohio, United States
iResearch Atlanta LLC
🇺🇸Decatur, Georgia, United States
Atlanta Behavioral Research, LLC
🇺🇸Dunwoody, Georgia, United States
Louisiana Clinical Research
🇺🇸Shreveport, Louisiana, United States
Synexus Clinical Research US, Inc.
🇺🇸Cerritos, California, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Samodzielny Publiczny Zespół Opieki Zdrowotnej
🇵🇱Chełmno, Poland
Centrum Badan Klinicznych PI-House
🇵🇱Gdansk, Poland
Indywidualna Specjalistyczna Praktyka
🇵🇱Poznan, Poland
INSPIRA Clinical Research
🇵🇷San Juan, Puerto Rico
Spitalul de Psihiatrie TITAN "Dr. Constantin Gorgoș", Bulevardul Nicolae Grigorescu, Nr. 41
🇷🇴București, Romania
Spital Clinic Judetean Tg. Mures
🇷🇴Targu Mures, Romania
Odessa Regional Medical Centre of Mental Health
🇺🇦Odesa, Ukraine
SI Institute of Neurology, Psychiatry and Narcology of NAMSU
🇺🇦Kharkiv, Ukraine
KNP of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
🇺🇦Lviv, Ukraine
University of California San Diego
🇺🇸San Diego, California, United States
Altea Research
🇺🇸Las Vegas, Nevada, United States
Alea Research Institute
🇺🇸Las Vegas, Nevada, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
Pillar Clinical Research
🇺🇸Richardson, Texas, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
Woodland Research Northwest, LLC
🇺🇸Rogers, Arkansas, United States
CITrials - Bellflower
🇺🇸Bellflower, California, United States
Collaborative Neuroscience Research Network, LLC.
🇺🇸Garden Grove, 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
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
CNRI-Los Angeles
🇺🇸Pico Rivera, California, United States
Excell Research, Inc
🇺🇸Oceanside, California, United States
Orange County Neuropsychiatric Research Center, LLC
🇺🇸Orange, California, United States
Wilks & Safirstein MD PA D/B/A MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
AMITA Health Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
CBH Health LLC
🇺🇸Gaithersburg, Maryland, United States
New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Clinical Inquest Center Ltd.
🇺🇸Beavercreek, Ohio, United States
Professional Psychiatric Services
🇺🇸Mason, Ohio, United States
State Psychiatry Hospital
🇧🇬Kardzhali, Bulgaria
MHAT Dr. Hristo Stambolski" EOOD; Department of Psychiatry
🇧🇬Kazanlak, Bulgaria
Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas
🇧🇬Burgas, Bulgaria
Pillar Healthcare
🇺🇸Richardson, Texas, United States
Mental health Centre-Ruse EOOD
🇧🇬Ruse, Bulgaria
UMHAT Dr. Georgi Stranski, EAD
🇧🇬Pleven, Bulgaria
State Psyciiatric Hospital - Lovech
🇧🇬Lovech, 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
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Inje University Heaundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Jeju National University Hospital
🇰🇷Jeju, Korea, Republic of
University Kuala Lumpur
🇲🇾Ipoh, Malaysia
Hospital Sentosa
🇲🇾Kuching, Malaysia
University Malaya Medical Center
🇲🇾Kuala Lumpur, Malaysia
Szpital Uniwersytecki Nr.1 im. Dr. A. Jurasza, Klinika Psychiatrii
🇵🇱Bydgoszcz, Poland
Specjalistyczna Praktyka lekarska
🇵🇱Lublin, Poland
Armys Clinical Emergency Central Hospital Prof Dr Carol Davila
🇷🇴Bucharest, Romania
Spitalul de Psihiatrie si Neurologie Brasov
🇷🇴Brasov, Romania
CETTT SF Stelian Hospital
🇷🇴București, Romania
Institute of Mental Health
🇷🇸Belgrade, Serbia
Special Hospital for Psychiatric Diseases "Kovin"
🇷🇸Kovin, Serbia
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Clinical Hospital Center Dr. Dragisa Misovic-Dedinje
🇷🇸Belgrade, Serbia
Clinical Centre Kragujevac
🇷🇸Kragujevac, Serbia
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
🇷🇸Novi Knezevac, Serbia
Clinic for Psychiatry, Clinical Centre of Vojvodina
🇷🇸Novi Sad, Serbia
National Cheng Kung University Hospital
🇨🇳Tainan City, Taiwan
Taipei Tzu Chi Hospital
🇨🇳New Taipei City, Taiwan
Department of Psychiatry, Taipei Veterans General Hospital, Taiwan
🇨🇳Taipei City, Taiwan
Suan prung Psychiatric Hospital
🇹🇭Mueang Nonthaburi, Thailand
Regional Psychonevrological Hospital #3
🇺🇦Ivano-Frankivsk, Ukraine
Kharkiv regional clinical psychiatric hospital #3
🇺🇦Kharkiv, Ukraine
Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrainian Railway"v
🇺🇦Kyiv, Ukraine
Geikivka multidisciplinary hospital for psychiatric care
🇺🇦Kyiv, Ukraine
Institute of Neurology, Psychiatry and Narcology of the NAMS of Ukraine
🇺🇦Kharkiv, Ukraine
Kyiv Regional Medical Incorporation "Psychiatry"
🇺🇦Kyiv, 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
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States