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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03593213
• Other study ID #: RGH-MD-24
• Secondary ID: 2017-000818-34
• Status: Terminated
• Phase: Phase 3
• Start date: July 30, 2018
• Est. completion date: February 11, 2021

Study information

• Verified date: April 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Other known NCT identifiers

• NCT04519099

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 587
• Est. completion date: February 11, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Cariprazine
Cariprazine capsules, oral administration, once daily.
• Placebo
Matching placebo capsules, oral administration, once daily.

Locations

Country	Name	City	State
Bulgaria	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	Ruse
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
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Inje University Heaundae Paik Hospital	Busan
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju
Malaysia	University Kuala Lumpur	Ipoh
Malaysia	University Malaya Medical Center	Kuala Lumpur
Malaysia	Hospital Sentosa	Kuching
Poland	Szpital Uniwersytecki Nr.1 im. Dr. A. Jurasza, Klinika Psychiatrii	Bydgoszcz
Poland	Samodzielny Publiczny Zespól Opieki Zdrowotnej	Chelmno
Poland	Centrum Badan Klinicznych PI-House	Gdansk
Poland	Specjalistyczna Praktyka lekarska	Lublin
Poland	Indywidualna Specjalistyczna Praktyka	Poznan
Puerto Rico	INSPIRA Clinical Research	San Juan
Romania	Spitalul de Psihiatrie si Neurologie Brasov	Brasov
Romania	Armys Clinical Emergency Central Hospital Prof Dr Carol Davila	Bucharest
Romania	CETTT SF Stelian Hospital	Bucure?ti
Romania	Spitalul de Psihiatrie TITAN "Dr. Constantin Gorgo?", Bulevardul Nicolae Grigorescu, Nr. 41	Bucure?ti
Romania	Spital Clinic Judetean Tg. Mures	Targu Mures
Serbia	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 Knezevac
Serbia	Clinic for Psychiatry, Clinical Centre of Vojvodina	Novi Sad
Taiwan	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 City
Thailand	Suan prung Psychiatric Hospital	Mueang Nonthaburi
Ukraine	Regional Psychonevrological Hospital #3	Ivano-Frankivsk
Ukraine	Institute of Neurology, Psychiatry and Narcology of the NAMS of Ukraine	Kharkiv
Ukraine	Kharkiv regional clinical psychiatric hospital #3	Kharkiv
Ukraine	SI Institute of Neurology, Psychiatry and Narcology of NAMSU	Kharkiv
Ukraine	Geikivka multidisciplinary hospital for psychiatric care	Kyiv
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	KNP of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"	Lviv
Ukraine	Odesa Regional Psychiatric Hospital No.2 of the ORC	Odesa
Ukraine	Odessa Regional Medical Centre of Mental Health	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
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Synexus Clinical Research, Inc	Atlanta	Georgia
United States	Community Clinical Research, Inc.	Austin	Texas
United States	Clinical Inquest Center Ltd.	Beavercreek	Ohio
United States	CITrials - Bellflower	Bellflower	California
United States	Pillar Clinical Research	Bentonville	Arkansas
United States	Hassman Research Institute	Berlin	New Jersey
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Synexus Clinical Research US, Inc.	Cerritos	California
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	OSY Psychiatry Department	Columbus	Ohio
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	iResearch Atlanta LLC	Decatur	Georgia
United States	Atlanta Behavioral Research, LLC	Dunwoody	Georgia
United States	CBH Health LLC	Gaithersburg	Maryland
United States	Collaborative Neuroscience Research Network, LLC.	Garden Grove	California
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	Wilks & Safirstein MD PA D/B/A MD Clinical	Hallandale Beach	Florida
United States	Southern Winds Hospital	Hialeah	Florida
United States	AMITA Health Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Research Centers of America	Hollywood	Florida
United States	Omega Clinical Trials	La Habra	California
United States	Alea Research Institute	Las Vegas	Nevada
United States	Altea Research	Las Vegas	Nevada
United States	Synergy San Diego	Lemon Grove	California
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Alliance Research	Long Beach	California
United States	Professional Psychiatric Services	Mason	Ohio
United States	Excell Research, Inc	Oceanside	California
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Orange County Neuropsychiatric Research Center, LLC	Orange	California
United States	CNRI-Los Angeles	Pico Rivera	California
United States	Pillar Clinical Research	Richardson	Texas
United States	Pillar Healthcare	Richardson	Texas
United States	Woodland Research Northwest, LLC	Rogers	Arkansas
United States	University of California San Diego	San Diego	California
United States	Schuster Medical Research Institute	Sherman Oaks	California
United States	Louisiana Clinical Research	Shreveport	Louisiana
United States	Collaborative Neuroscience Research, LLC	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Bulgaria,  Korea, Republic of,  Malaysia,  Poland,  Puerto Rico,  Romania,  Serbia,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Randomization (Week 18) to End of Treatment (Week 44)