Clinical Trials Logo

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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A