Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients 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: Recruiting

Administrative data

• NCT number: NCT04519099
• Other study ID #: RGH-MD-24
• Secondary ID: 2017-000818-34
• Status: Recruiting
• Phase: Phase 3
• Start date: July 30, 2018
• Est. completion date: April 8, 2022

Study information

• Verified date: August 2020
• Source: Allergan
• Contact: Clinical Trials Registry Team
• Phone: 877-277-8566
• Email: IR-CTRegistration[@]Allergan.com
• 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 345
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• 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.

• 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.

• Patient meets DSM-5 criteria for schizophrenia as determined by SCID-5.

• PANSS total score = 70 and = 120 at Visit 1 and Visit 2.

• Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behavior; 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 patients 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	MHAT "Dr. Hristo Stambolski", EOOD	Kazanlak
Bulgaria	State Psyciiatric Hospital - Lovech	Lovech
Bulgaria	UMHAT Dr. Georgi Stranski, EAD	Pleven
Bulgaria	Regional Psychiatric Dispensary Ruse	Ruse
Bulgaria	MHAT-Targovishte, AD	Targovishte
Bulgaria	DCC Mladost M - Varna, OOD	Varna
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	Sultanah Aminah Hospital	Johor Bahru
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 Praktyka Lekarska	Poznan
Poland	Mazowiecki Szpital Bródnowski w Warszawie Sp. z o. o. Bródnowskie Centrum Specjalistyczne	Warszawa
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
Russian Federation	Sverdlovsk Regional Clinical Psychiatric Hospital	Ekaterinburg
Russian Federation	Mental Health Research Centre, Dept. of Endogenous Psychic Disorders and Affective State	Moscow
Russian Federation	Moscow Research Institute of Psychaitry - the Branch of V.Serbsky National Medical Research Centre of Psychiatry and Narcology)	Moscow
Russian Federation	Research Center of Mental Health	Moscow
Russian Federation	State Healthcare Institution of Nizhegorodsky Region (SHI NR) 'Clinical Psychiatry Hospital #1 of Nizhny Novgorod City'	Nizhny Novgorod
Russian Federation	Kazan State Medical University	Respublika Tatarstan
Russian Federation	Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky	Saratov
Russian Federation	City Psyconeurological Hospital #3 n.a. I.I. Skvortsov-Stepanov	St. Petersburg
Russian Federation	Federal Budgetary State Institution National Medical Research Centre for Psychiatry and Neurology named after Bekhterev	St. Petersburg
Russian Federation	National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev	St. Petersburg
Russian Federation	Tomsk National Research Medical Center of the Russian Academy of Sciences	Tomsk
Russian Federation	Region Specialized Psychiatric Hospital #2	Tonnelniy
Russian Federation	State Budget Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Psychiatric Hospital"	Yekaterinburg
Serbia	Clinic of Psychiatric Diseases - Dr. Laza Lazarevic	Belgrade
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	Tri-Service General Hospital	Neihu
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	Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University	Chiang Mai
Thailand	Suanprung Psychiatric Hospital	Muang
Ukraine	Regional Psychonevrological Hospital #3	Frankivsk
Ukraine	Municipal Institution "Kharkiv Regional Clinical Psychiatric Hospital #3"	Kharkiv
Ukraine	SI Institute of Neurology, Psychiatry and Narcology of NAMSU	Kharkiv
Ukraine	State Institution "Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine"	Kharkiv
Ukraine	Geikivka Regional Psychiatric Hospital	Kyiv
Ukraine	Kyiv Medical Regional Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders	Kyiv
Ukraine	Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrainian Railway"v	Kyiv
Ukraine	Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #20, Lviv National Medical University named after Danylo Halytsky	Lviv
Ukraine	Odesa Regional Medical Center for Psychological Health of the Odesa Regional Council	Odesa
Ukraine	Odesa Regional Psychiatric Hospital No.2	Odesa
Ukraine	CI Kherson Regional Psychiatric Hospital of Kherson RC	Petrivka
Ukraine	CI Cherkasy Regional Psychiatric Hospital of ChRC	Smila
Ukraine	CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU	Vinnytsia
Ukraine	Vinnytsia Regional Psycho-Neurological Hospital	Vinnytsia
United States	Advanced Research Center, Inc.	Anaheim	California
United States	California Pharmaceutical Research Institute, Inc.	Anaheim	California
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Synexus Atlanta	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 California	Cerritos	California
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	OSU Psychiatry Department	Columbus	Ohio
United States	ATP Clinical Research, Inc.	Costa Mesa	California
United States	ProScience Research Group	Culver City	California
United States	Agile Clinical Research Trials, LLC	Decatur	Georgia
United States	iResearch Atlanta	Decatur	Georgia
United States	InSite Clinical Research	DeSoto	Texas
United States	Atlanta Behavioral Research, LLC	Dunwoody	Georgia
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	CBH Health LLC	Gaithersburg	Maryland
United States	Collaborative Neuroscience 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	Alexian Brothers Hospital Network	Hoffman Estates	Illinois
United States	AMITA Health Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Research Centers of America, LLC	Hollywood	Florida
United States	JOST Clinical Research	Houston	Texas
United States	Omega Clinical Trials	La Habra	California
United States	Altea Research	Las Vegas	Nevada
United States	Altea Research Institute	Las Vegas	Nevada
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	Synergy San Diego	National City	California
United States	Excell Research, Inc	Oceanside	California
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Orange County Neuropsychiatric Research Center, LLC d/b/a NRC Research Institute	Orange	California
United States	Meridien Research, Inc.	Orlando	Florida
United States	CNRI Los Angelas	Pico Rivera	California
United States	Pillar Clinical Research	Richardson	Texas
United States	Pillar Clinical Research	Richardson	Texas
United States	Woodland Research Northwest, LLC	Rogers	Arkansas
United States	St. Charles Psychiatric Associates - Midwest Research Group	Saint Charles	Missouri
United States	Artemis Institute for Clinical Research	San Diego	California
United States	University of California San Diego/UCSD	San Diego	California
United States	Schuster Medical Research Institute	Sherman Oaks	California
United States	Louisiana Clinical Research	Shreveport	Louisiana
United States	Collaborative Neuroscience Network	Torrance	California
United States	Inova Clinical Trials and Research Center	Tyrone	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy parameter is the time to first relapse during the DB treatment period, defined as the number of days from the randomization date to the first relapse date.	Relapse is defined as the occurrence of any 1 of the following: Increase in PANSS total score by = 30% for patients who had a PANSS total score of; = 50 at Randomization/Visit 13 or a = 10-point increase in PANSS total score for patients who had a PANSS total score < 50 at Randomization/Visit 13; Increase in CGI-S score by 2 or more points relative to Randomization/Visit 13; Score of > 4 on 1 or more of the following 7 PANSS items: P1; P2; P3; P6; P7; G8; G14; Deliberate self-injury or aggressive/violent behavior; Initiation of treatment with a mood stabilizer, antidepressant, antipsychotic agent, or with a benzodiazepine exceeding protocol-specified allowance to treat worsening symptoms of schizophrenia/any other psychiatric disorder as judged by the investigator; Psychiatric hospitalization due to worsening of the underlying condition; Exacerbation of psychiatric illness as judged by the investigator	From Visit 11 (Week 14) up to Visit 26 (Week 44)

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.