SchizophreniaPhase 3NCT03593213
Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
A Phase 3 study testing Cariprazine in people with Schizophrenia, run by AbbVie at 97 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cariprazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 587 participants
- Where
- 97 sitesin 11 countries
- Study dates
- 30 Jul 2018to 11 Feb 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
97 sites in 11 countries.
97 sites in 11 countries
United States42 sites
Advanced Research Center, Inc.
Anaheim, California, 92805
Synexus Clinical Research, Inc
Atlanta, Georgia, 30328
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Community Clinical Research, Inc.
Austin, Texas, 78754
Clinical Inquest Center Ltd.
Beavercreek, Ohio, 45431
CITrials - Bellflower
Bellflower, California, 90706
Pillar Clinical Research
Bentonville, Arkansas, 72712
Hassman Research Institute
Berlin, New Jersey, 08009
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Synexus Clinical Research US, Inc.
Cerritos, California, 90703
New Hope Clinical Research
Charlotte, North Carolina, 28211
OSY Psychiatry Department
Columbus, Ohio, 43210
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
California Pharmaceutical Research Institute, Inc.
Costa Mesa, California, 92626
ProScience Research Group
Culver City, California, 90230
iResearch Atlanta LLC
Decatur, Georgia, 30030
Atlanta Behavioral Research, LLC
Dunwoody, Georgia, 30338
CBH Health LLC
Gaithersburg, Maryland, 20877
Collaborative Neuroscience Research Network, LLC.
Garden Grove, California, 92845
Behavioral Research Specialists, LLC
Glendale, California, 91206
Wilks & Safirstein MD PA D/B/A MD Clinical
Hallandale, Florida, 33009
Southern Winds Hospital
Hialeah, Florida, 33012
AMITA Health Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
Research Centers of America
Hollywood, Florida, 33024
Omega Clinical Trials
La Habra, California, 90631
Altea Research
Las Vegas, Nevada, 85012
Alea Research Institute
Las Vegas, Nevada, 89102
Synergy San Diego
Lemon Grove, California, 91945
Woodland International Research Group
Little Rock, Arkansas, 72211
Alliance Research
Long Beach, California, 90807
Professional Psychiatric Services
Mason, Ohio, 45069
Excell Research, Inc
Oceanside, California, 92056
Sooner Clinical Research
Oklahoma City, Oklahoma, 23112
Orange County Neuropsychiatric Research Center, LLC
Orange, California, 92868
CNRI-Los Angeles
Pico Rivera, California, 90660
Pillar Clinical Research
Richardson, Texas, 75042
Pillar Healthcare
Richardson, Texas, 75080
Woodland Research Northwest, LLC
Rogers, Arkansas, 72758
University of California San Diego
San Diego, California, 92103-8229
Schuster Medical Research Institute
Sherman Oaks, California, 91423
Louisiana Clinical Research
Shreveport, Louisiana, 71101
Collaborative Neuroscience Research, LLC
Torrance, California, 90502
Ukraine14 sites
Regional Psychonevrological Hospital #3
Ivano-Frankivsk, 76014
Kharkiv regional clinical psychiatric hospital #3
Kharkiv, 31068
Institute of Neurology, Psychiatry and Narcology of the NAMS of Ukraine
Kharkiv, 61068
SI Institute of Neurology, Psychiatry and Narcology of NAMSU
Kharkiv, 61068
Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of the Public Joint Stock Company "Ukrainian Railway"v
Kyiv, 03049
Kyiv Regional Medical Incorporation "Psychiatry"
Kyiv, 04080
Geikivka multidisciplinary hospital for psychiatric care
Kyiv, 53054
KNP of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
Lviv, 79021
Odessa Regional Medical Centre of Mental Health
Odesa, 65006
Odesa Regional Psychiatric Hospital No.2 of the ORC
Odesa, 67513
Kherson Regional Psychiatric Institution for Psychiatric Care
Petrivka, 73488
Cherkasy regional psychiatric hospital of the CRC
Smila, 20704
CI O.I. Yuschenko VRPsH Depts No.14 and No.15 M.I. Pyrogov VNMU
Vinnytsia, 21005
VNMU
Vinnytsia, 21005
Bulgaria10 sites
Mental Health Centre - Prof.Dr.Ivan Temkov-Burgas
Burgas, 8000
State Psychiatry Hospital
Kardzhali, 6600
MHAT Dr. Hristo Stambolski" EOOD; Department of Psychiatry
Kazanlak, 6100
State Psyciiatric Hospital - Lovech
Lovech, 5500
UMHAT Dr. Georgi Stranski, EAD
Pleven, 5800
Mental health Centre-Ruse EOOD
Rousse, 7003
MHAT-Targovishte, AD
Targovishte, 7700
DCC Mladost M - Varna, OOD
Varna, 9000
Mental Health Center - Veliko Tarnovo EOOD, Veliko Tarnovo
Veliko Tarnovo, 5000
Mental Health Center - Vratsa EOOD, Vratsa
Vratsa, 3000
Serbia8 sites
Clinical Center of Serbia
Belgrade, 11000
Clinical Hospital Center Dr. Dragisa Misovic-Dedinje
Belgrade, 11000
Institute of Mental Health
Belgrade, 11000
Special Hospital for Psychiatric Diseases "Kovin"
Kovin, 26220
Clinical Centre Kragujevac
Kragujevac, 34000
Clinical Centre Kragujevac
Kragujevac, 3400
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
Novi Kneževac, 23330
Clinic for Psychiatry, Clinical Centre of Vojvodina
Novi Sad, 21000
Poland5 sites
Szpital Uniwersytecki Nr.1 im. Dr. A. Jurasza, Klinika Psychiatrii
Bydgoszcz, 85-094
Samodzielny Publiczny Zespół Opieki Zdrowotnej
Chełmno, 86-200
Centrum Badan Klinicznych PI-House
Gdansk, 80-546
Specjalistyczna Praktyka lekarska
Lublin, 20-589
Indywidualna Specjalistyczna Praktyka
Poznan, 60744
Romania5 sites
Spitalul de Psihiatrie si Neurologie Brasov
Brasov, 500079
Spitalul de Psihiatrie TITAN "Dr. Constantin Gorgoș", Bulevardul Nicolae Grigorescu, Nr. 41
Bucharest, 30447
Armys Clinical Emergency Central Hospital Prof Dr Carol Davila
Bucharest, 60011
CETTT SF Stelian Hospital
Bucharest, 60222
Spital Clinic Judetean Tg. Mures
Târgu Mureş, 540142
South Korea5 sites
Inje University Busan Paik Hospital
Busan, 47392
Inje University Heaundae Paik Hospital
Busan, 48108
Chonnam National University Hospital
Gwangju, 61469
Gachon University Gil Medical Center
Incheon, 405-760
Jeju National University Hospital
Jeju City, 63241
Malaysia3 sites
University Kuala Lumpur
Ipoh, 30450
University Malaya Medical Center
Kuala Lumpur, 59100
Hospital Sentosa
Kuching, 93250
Taiwan3 sites
Taipei Tzu Chi Hospital
New Taipei City, 23142
National Cheng Kung University Hospital
Tainan, 70428
Department of Psychiatry, Taipei Veterans General Hospital, Taiwan
Taipei, 112
About this study
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
- 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
- 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
- Being tested
- Cariprazine, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CariprazineDrug
Cariprazine capsules, oral administration, once daily.
PlaceboDrug
Matching placebo capsules, oral administration, once daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Cariprazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Randomization (Week 18) to End of Treatment (Week 44)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start30 Jul 2018
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Why it stopped: FDA Released Allergan from this post marketing requirement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593213
- Sponsor's protocol ID
- RGH-MD-24
- Other IDs
- 2017-000818-34, 2017
- Status last verified
- Apr 2022
- First submitted
- 10 Jul 2018
- Last updated
- 11 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03593213
- Acronym / sponsor ID
- RGH-MD-24
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA Released Allergan from this post marketing requirement
- Enrolment
- 587 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 8 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cariprazine 4.5 mg/day (Open-label Treatment Period) | Experimental | Drug: CariprazineCariprazine 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. |
| Placebo (Double-blind Treatment Period) | Placebo comparator | Drug: PlaceboCariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period. |
| Cariprazine 3.0 mg/day (Double-blind Treatment Period) | Experimental | Drug: CariprazineCariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period. |
| Cariprazine 4.5 mg/day (Double-blind Treatment Period) | Experimental | Drug: CariprazineCariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CariprazineCariprazine capsules, oral administration, once daily. | Drug | 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) |
| PlaceboMatching placebo capsules, oral administration, once daily. | Drug | Placebo (Double-blind Treatment Period) |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
97 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cariprazine in people with Schizophrenia, run by AbbVie at 97 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in United States, Ukraine, Bulgaria, Serbia, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Relapse During Double-blind Treatment Period (time frame: Randomization (Week 18) to End of Treatment (Week 44)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.