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

NCT03593213 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: RGH-MD-242017-000818-34
• Study Type: interventional
• Target: 587
• Locations: 11 countries
• Sites: 97

Brief Summary

1. 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. 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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (4)

Cariprazine 4.5 mg/day (Open-label Treatment Period)

EXPERIMENTAL

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.

Drug: Cariprazine

Placebo (Double-blind Treatment Period)

PLACEBO COMPARATOR

Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Drug: Placebo

Cariprazine 3.0 mg/day (Double-blind Treatment Period)

EXPERIMENTAL

Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Drug: Cariprazine

Cariprazine 4.5 mg/day (Double-blind Treatment Period)

EXPERIMENTAL

Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.

Drug: Cariprazine

Interventions

Cariprazine DRUG

Cariprazine capsules, oral administration, once daily.

Cariprazine 3.0 mg/day (Double-blind Treatment Period); Cariprazine 4.5 mg/day (Double-blind Treatment Period); Cariprazine 4.5 mg/day (Open-label Treatment Period)

Placebo DRUG

Matching placebo capsules, oral administration, once daily.

Placebo (Double-blind Treatment Period)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (97)

Pillar Clinical Research

Bentonville, Arkansas, 72712, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest, LLC

Rogers, Arkansas, 72758, United States

Location

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

CITrials - Bellflower

Bellflower, California, 90706, United States

Location

Synexus Clinical Research US, Inc.

Cerritos, California, 90703, United States

Location

ATP Clinical Research, Inc.

Costa Mesa, California, 92626, United States

Location

California Pharmaceutical Research Institute, Inc.

Costa Mesa, California, 92626, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Collaborative Neuroscience Research Network, LLC.

Garden Grove, California, 92845, United States

Location

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

Location

Omega Clinical Trials

La Habra, California, 90631, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

Alliance Research

Long Beach, California, 90807, United States

Location

Excell Research, Inc

Oceanside, California, 92056, United States

Location

Orange County Neuropsychiatric Research Center, LLC

Orange, California, 92868, United States

Location

CNRI-Los Angeles

Pico Rivera, California, 90660, United States

Location

University of California San Diego

San Diego, California, 92103-8229, United States

Location

Schuster Medical Research Institute

Sherman Oaks, California, 91423, United States

Location

Collaborative Neuroscience Research, LLC

Torrance, California, 90502, United States

Location

Wilks & Safirstein MD PA D/B/A MD Clinical

Hallandale, Florida, 33009, United States

Location

Southern Winds Hospital

Hialeah, Florida, 33012, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Synexus Clinical Research, Inc

Atlanta, Georgia, 30328, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta LLC

Decatur, Georgia, 30030, United States

Location

Atlanta Behavioral Research, LLC

Dunwoody, Georgia, 30338, United States

Location

AMITA Health Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, 60169, United States

Location

Louisiana Clinical Research

Shreveport, Louisiana, 71101, United States

Location

CBH Health LLC

Gaithersburg, Maryland, 20877, United States

Location

Altea Research

Las Vegas, Nevada, 85012, United States

Location

Alea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

Location

Clinical Inquest Center Ltd.

Beavercreek, Ohio, 45431, United States

Location

OSY Psychiatry Department

Columbus, Ohio, 43210, United States

Location

Professional Psychiatric Services

Mason, Ohio, 45069, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 23112, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

Pillar Clinical Research

Richardson, Texas, 75042, United States

Location

Pillar Healthcare

Richardson, Texas, 75080, United States

Location

Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas

Burgas, 8000, Bulgaria

Location

State Psychiatry Hospital

Kardzhali, 6600, Bulgaria

Location

MHAT Dr. Hristo Stambolski" EOOD; Department of Psychiatry

Kazanlak, 6100, Bulgaria

Location

State Psyciiatric Hospital - Lovech

Lovech, 5500, Bulgaria

Location

UMHAT Dr. Georgi Stranski, EAD

Pleven, 5800, Bulgaria

Location

Mental health Centre-Ruse EOOD

Rousse, 7003, Bulgaria

Location

MHAT-Targovishte, AD

Targovishte, 7700, Bulgaria

Location

DCC Mladost M - Varna, OOD

Varna, 9000, Bulgaria

Location

Mental Health Center - Veliko Tarnovo EOOD, Veliko Tarnovo

Veliko Tarnovo, 5000, Bulgaria

Location

Mental Health Center - Vratsa EOOD, Vratsa

Vratsa, 3000, Bulgaria

Location

University Kuala Lumpur

Ipoh, 30450, Malaysia

Location

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Location

Hospital Sentosa

Kuching, 93250, Malaysia

Location

Szpital Uniwersytecki Nr.1 im. Dr. A. Jurasza, Klinika Psychiatrii

Bydgoszcz, 85-094, Poland

Location

Samodzielny Publiczny Zespół Opieki Zdrowotnej

Chełmno, 86-200, Poland

Location

Centrum Badan Klinicznych PI-House

Gdansk, 80-546, Poland

Location

Specjalistyczna Praktyka lekarska

Lublin, 20-589, Poland

Location

Indywidualna Specjalistyczna Praktyka

Poznan, 60744, Poland

Location

INSPIRA Clinical Research

San Juan, 918, Puerto Rico

Location

Spitalul de Psihiatrie si Neurologie Brasov

Brasov, 500079, Romania

Location

Spitalul de Psihiatrie TITAN "Dr. Constantin Gorgoș", Bulevardul Nicolae Grigorescu, Nr. 41

Bucharest, 30447, Romania

Location

Armys Clinical Emergency Central Hospital Prof Dr Carol Davila

Bucharest, 60011, Romania

Location

CETTT SF Stelian Hospital

Bucharest, 60222, Romania

Location

Spital Clinic Judetean Tg. Mures

Târgu Mureş, 540142, Romania

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Dr. Dragisa Misovic-Dedinje

Belgrade, 11000, Serbia

Location

Institute of Mental Health

Belgrade, 11000, Serbia

Location

Special Hospital for Psychiatric Diseases "Kovin"

Kovin, 26220, Serbia

Location

Clinical Centre Kragujevac

Kragujevac, 34000, Serbia

Location

Clinical Centre Kragujevac

Kragujevac, 3400, Serbia

Location

Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi

Novi Kneževac, 23330, Serbia

Location

Clinic for Psychiatry, Clinical Centre of Vojvodina

Novi Sad, 21000, Serbia

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Inje University Heaundae Paik Hospital

Busan, 48108, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Jeju National University Hospital

Jeju City, 63241, South Korea

Location

Taipei Tzu Chi Hospital

New Taipei City, 23142, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70428, Taiwan

Location

Department of Psychiatry, Taipei Veterans General Hospital, Taiwan

Taipei, 112, Taiwan

Location

Suan prung Psychiatric Hospital

Nonthaburi, 50100, Thailand

Location

Regional Psychonevrological Hospital #3

Ivano-Frankivsk, 76014, Ukraine

Location

Kharkiv regional clinical psychiatric hospital #3

Kharkiv, 31068, Ukraine

Location

Institute of Neurology, Psychiatry and Narcology of the NAMS of Ukraine

Kharkiv, 61068, Ukraine

Location

SI Institute of Neurology, Psychiatry and Narcology of NAMSU

Kharkiv, 61068, Ukraine

Location

Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrainian Railway"v

Kyiv, 03049, Ukraine

Location

Kyiv Regional Medical Incorporation "Psychiatry"

Kyiv, 04080, Ukraine

Location

Geikivka multidisciplinary hospital for psychiatric care

Kyiv, 53054, Ukraine

Location

KNP of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"

Lviv, 79021, Ukraine

Location

Odessa Regional Medical Centre of Mental Health

Odesa, 65006, Ukraine

Location

Odesa Regional Psychiatric Hospital No.2 of the ORC

Odesa, 67513, Ukraine

Location

Kherson Regional Psychiatric Institution for Psychiatric Care

Petrivka, 73488, Ukraine

Location

Cherkasy regional psychiatric hospital of the CRC

Smila, 20704, Ukraine

Location

CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU

Vinnytsia, 21005, Ukraine

Location

VNMU

Vinnytsia, 21005, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 20, 2018
• Study Start: July 30, 2018
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: April 11, 2022
• Results First Posted: March 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

Locations

PL (5); KR (5); MY (3); RO (5); SE (8); PR (1); UA (14); BU (10); TH (1); US (42); TW (3)