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

April 7, 2022 updated by: AbbVie

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

  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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
587

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas
      • Kardzhali, Bulgaria, 6600
        • State Psychiatry Hospital
      • Kazanlak, Bulgaria, 6100
        • MHAT Dr. Hristo Stambolski" EOOD; Department of Psychiatry
      • Lovech, Bulgaria, 5500
        • State Psyciiatric Hospital - Lovech
      • Pleven, Bulgaria, 5800
        • UMHAT Dr. Georgi Stranski, EAD
      • Ruse, Bulgaria, 7003
        • Mental health Centre-Ruse EOOD
      • Targovishte, Bulgaria, 7700
        • MHAT-Targovishte, AD
      • Varna, Bulgaria, 9000
        • DCC Mladost M - Varna, OOD
      • Veliko Tarnovo, Bulgaria, 5000
        • Mental Health Center - Veliko Tarnovo EOOD, Veliko Tarnovo
      • Vratsa, Bulgaria, 3000
        • Mental Health Center - Vratsa EOOD, Vratsa
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Inje university busan paik hospital
      • Busan, Korea, Republic of, 48108
        • Inje University Heaundae Paik Hospital
      • Gwangju, Korea, Republic of, 61469
        • Chonnam National University Hospital
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
      • Jeju, Korea, Republic of, 63241
        • Jeju National University Hospital
  • Malaysia
      • Ipoh, Malaysia, 30450
        • University Kuala Lumpur
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Center
      • Kuching, Malaysia, 93250
        • Hospital Sentosa
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Szpital Uniwersytecki Nr.1 im. Dr. A. Jurasza, Klinika Psychiatrii
      • Chełmno, Poland, 86-200
        • Samodzielny Publiczny Zespół Opieki Zdrowotnej
      • Gdansk, Poland, 80-546
        • Centrum Badan Klinicznych PI-House
      • Lublin, Poland, 20-589
        • Specjalistyczna Praktyka Lekarska
      • Poznan, Poland, 60744
        • Indywidualna Specjalistyczna Praktyka
  • Puerto Rico
      • San Juan, Puerto Rico, 918
        • INSPIRA Clinical Research
  • Romania
      • Brasov, Romania, 500079
        • Spitalul de Psihiatrie și Neurologie Brașov
      • Bucharest, Romania, 60011
        • Armys Clinical Emergency Central Hospital Prof Dr Carol Davila
      • București, Romania, 30447
        • Spitalul de Psihiatrie TITAN "Dr. Constantin Gorgoș", Bulevardul Nicolae Grigorescu, Nr. 41
      • București, Romania, 60222
        • CETTT SF Stelian Hospital
      • Targu Mures, Romania, 540142
        • Spital Clinic Judetean Tg. Mures
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbia, 11000
        • Institute of Mental Health
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Dr. Dragisa Misovic-Dedinje
      • Kovin, Serbia, 26220
        • Special Hospital for Psychiatric Diseases "Kovin"
      • Kragujevac, Serbia, 34000
        • Clinical Centre Kragujevac
      • Kragujevac, Serbia, 3400
        • Clinical Centre Kragujevac
      • Novi Knezevac, Serbia, 23330
        • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
      • Novi Sad, Serbia, 21000
        • Clinic for Psychiatry, Clinical Centre of Vojvodina
  • Taiwan
      • New Taipei City, Taiwan, 23142
        • Taipei Tzu Chi Hospital
      • Tainan City, Taiwan, 70428
        • National Cheng Kung University Hospital
      • Taipei City, Taiwan, 112
        • Department of Psychiatry, Taipei Veterans General Hospital, Taiwan
  • Thailand
      • Mueang Nonthaburi, Thailand, 50100
        • Suan Prung Psychiatric Hospital
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76014
        • Regional Psychonevrological Hospital #3
      • Kharkiv, Ukraine, 61068
        • SI Institute of Neurology, Psychiatry and Narcology of NAMSU
      • Kharkiv, Ukraine, 31068
        • Kharkiv regional clinical psychiatric hospital #3
      • Kharkiv, Ukraine, 61068
        • Institute of Neurology, Psychiatry and Narcology of the NAMS of Ukraine
      • Kyiv, Ukraine, 03049
        • Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrainian Railway"v
      • Kyiv, Ukraine, 04080
        • Kyiv Regional Medical Incorporation "Psychiatry"
      • Kyiv, Ukraine, 53054
        • Geikivka multidisciplinary hospital for psychiatric care
      • Lviv, Ukraine, 79021
        • KNP of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
      • Odesa, Ukraine, 65006
        • Odessa Regional Medical Centre of Mental Health
      • Odesa, Ukraine, 67513
        • Odesa Regional Psychiatric Hospital No.2 of the ORC
      • Petrivka, Ukraine, 73488
        • Kherson Regional Psychiatric Institution for Psychiatric Care
      • Smila, Ukraine, 20704
        • Cherkasy regional psychiatric hospital of the CRC
      • Vinnytsia, Ukraine, 21005
        • CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU
      • Vinnytsia, Ukraine, 21005
        • VNMU
  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Pillar Clinical Research
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group
      • Rogers, Arkansas, United States, 72758
        • Woodland Research Northwest, LLC
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center, Inc.
      • Bellflower, California, United States, 90706
        • CITrials - Bellflower
      • Cerritos, California, United States, 90703
        • Synexus Clinical Research US, Inc.
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research, Inc.
      • Costa Mesa, California, United States, 92626
        • California Pharmaceutical Research Institute, Inc.
      • Culver City, California, United States, 90230
        • ProScience Research Group
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Research Network, LLC.
      • Glendale, California, United States, 91206
        • Behavioral Research Specialists, LLC
      • La Habra, California, United States, 90631
        • Omega Clinical Trials
      • Lemon Grove, California, United States, 91945
        • Synergy San Diego
      • Long Beach, California, United States, 90807
        • Alliance Research
      • Oceanside, California, United States, 92056
        • Excell Research, Inc
      • Orange, California, United States, 92868
        • Orange County Neuropsychiatric Research Center, LLC
      • Pico Rivera, California, United States, 90660
        • CNRI-Los Angeles
      • San Diego, California, United States, 92103-8229
        • University of California San Diego
      • Sherman Oaks, California, United States, 91423
        • Schuster Medical Research Institute
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Research, LLC
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • Wilks & Safirstein MD PA D/B/A MD Clinical
      • Hialeah, Florida, United States, 33012
        • Southern Winds Hospital
      • Hollywood, Florida, United States, 33024
        • Research Centers of America
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30328
        • Synexus Clinical Research, Inc
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta LLC
      • Dunwoody, Georgia, United States, 30338
        • Atlanta Behavioral Research, LLC
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • AMITA Health Alexian Brothers Center for Psychiatric Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Louisiana Clinical Research
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health LLC
    • Nevada
      • Las Vegas, Nevada, United States, 85012
        • Altea Research
      • Las Vegas, Nevada, United States, 89102
        • Alea Research Institute
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • New Hope Clinical Research
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Clinical Inquest Center Ltd.
      • Columbus, Ohio, United States, 43210
        • OSY Psychiatry Department
      • Mason, Ohio, United States, 45069
        • Professional Psychiatric Services
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 23112
        • Sooner Clinical Research
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research, Inc.
      • Richardson, Texas, United States, 75042
        • Pillar Clinical Research
      • Richardson, Texas, United States, 75080
        • Pillar Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cariprazine 4.5 mg/day (Open-label Treatment Period)
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
Cariprazine capsules, oral administration, once daily.
Placebo Comparator: Placebo (Double-blind Treatment Period)
Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Drug: Placebo
Matching placebo capsules, oral administration, once daily.
Experimental: Cariprazine 3.0 mg/day (Double-blind Treatment Period)
Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily.
Experimental: Cariprazine 4.5 mg/day (Double-blind Treatment Period)
Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
Drug: Cariprazine
Cariprazine capsules, oral administration, once daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to First Relapse During Double-blind Treatment Period
Time Frame: 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
Randomization (Week 18) to End of Treatment (Week 44)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RGH-MD-24
  • 2017-000818-34 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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