SchizophreniaPhase 3NCT03817502
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
A Phase 3 study testing Cariprazine in people with Schizophrenia, run by Gedeon Richter Plc. at 57 sites in 8 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population. Read more about this study
- Who is it for?
- Ages 13 to 17 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
- 330 participants
- Where
- 57 sitesin 8 countries
- Study dates
- 6 Jun 2019to 15 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-5 primary diagnosis of schizophrenia.
- Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician.
- PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2).
- CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2).
Who cannot join
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
- Diagnosis of intellectual disability (IQ < 70).
- Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Visit 1.
Trial locations and contacts
57 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
57 sites in 8 countries
Russia19 sites
- Terminated
State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
Arkhangelsk, 163530
- Suspended
Kazan State Medical University KSMU
Kazan', 420012
- Terminated
SBHI Specialized Clinical Psychiatric Hospital 1
Krasnodar, 350007
- Terminated
Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"
Lipetsk, 399083
- Terminated
Joint-Stock Company Scientific Centre of Personalized Medicine
Moscow, 105082
- Terminated
SBHI of Moscow Region "Central Clinical Psychiatric Hospital"
Moscow, 127083
- Terminated
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod
Nizhny Novgorod, 603155
- Terminated
State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
Roshchino, 188820
- Terminated
Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko
Saint Petersburg, 190121
- Terminated
Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" of the Ministry of Healthcare of the Russian Federation
Saint Petersburg, 192019
- Terminated
Center for Medical Rehabilitation named after S.S. Mnukhin
Saint Petersburg, 197022
- Terminated
City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova
Saint Petersburg, 197341
- Suspended
GBUZ Samara Regional Clinical Psychiatric Hospital
Samara, 443016
- Terminated
State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"
Saratov, 410028
- Suspended
Smolensk State Medical University
Smolensk, 214019
- Terminated
LLC Podderzhka
Stavropol, 355038
- Terminated
LLC Clinic "Sto Let"
Tomsk, 634014
- Terminated
Stavropol Regional Psychiatric hospital #2
Tonnel'nyy, 357034
- Terminated
Yaroslavl Regional Psychiatric Hospital
Yaroslavl Region, 634009
United States9 sites
- Completed
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
- Withdrawn
Atlanta Behavioral Research, LLC
Atlanta, Georgia, 30338
- Withdrawn
Bloomfield Hills MI
Bloomfield Hills, Michigan, 48302
- Withdrawn
UB Department of Psychiatry
Buffalo, New York, 142515
- Completed
University of Cincinnati
Cincinnati, Ohio, 45219
- Completed
ProScience Research Group
Culver City, California, 90230
- Withdrawn
Precise Research Centers
Flowood, Mississippi, 39232
- Withdrawn
Manhattan Behavioral Medicine PLLC
New York, New York, 10036
- Completed
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381
Mexico9 sites
- Suspended
Centro para la Medicina y de Asistencia Medica Especializada S.C.
Culiacán, 80230
- Suspended
Instituto de Investigacion Clinica AC
Durango, 34000
- Withdrawn
Consultorio de Medicina Especializada del Sector Privado
Guadalajara, 44690
- Suspended
Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra
Guanajuato City, 37000
- Active, not recruiting
Medical Care and Research S.A. de C.V.
Mérida, 97070
- Suspended
Iecsi S.C.
Monterrey, 64310
- Suspended
CIT Neuropsique
Monterrey, 64610
- Suspended
Instituto de Informacion e Investigacion en Salud Mental AC
Monterrey, 64710
- Suspended
BLIND Investigaciones SC
San Luis Potosí City, 78213
Ukraine8 sites
- Terminated
Regional Psychonevrological Hospital #3
Ivano-Frankivsk, 76011
- Terminated
SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"
Kharkiv, 61068
- Terminated
State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine
Kharkiv, 61153
- Terminated
Kherson Regional Institution of Mental Care
Kherson, 73488
- Terminated
SI Research Institute of Psychiatry of MoH of Ukraine
Kyiv, 04108
- Terminated
Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital
Lviv, 79021
- Terminated
Odesa Regional Medical Centre of Mental Health
Odesa, 65006
- Terminated
Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"
Vinnytsia, 21018
Colombia5 sites
- Suspended
Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.
Barranquilla, 080020
- Suspended
E.S.E. Hospital Mental de Antioquia
Bello, 051053
- Suspended
Centro de Investigacion del Sitema Nervioso CISNE
Bogotá, 1111666
- Suspended
Instituto Colombiano Sistema Nervioso Clinica Monserrat
Bogotá, 250051
- Suspended
Psynapsis Salud Mental SA
Pereira, 660003
Serbia3 sites, 1 recruiting
- Terminated
Clinic.Neuro.Psych.Child.Youth
Belgrade, 11000
- Terminated
Institute for Mental Health
Belgrade, 11000
- Recruiting
Clinic for psychiatry, KCV
Novi Sad, 21000
Bulgaria2 sites, 2 recruiting
- Recruiting
Clinic of Child Psychiatry St. Nikolas
Sofia, 1431
- Recruiting
MHAT Targovishte
Targovishte, 7700
Romania2 sites, 1 recruiting
- Withdrawn
Socola Psychiatric Institute Iasi
Iași, 700282
- Recruiting
Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti
Timișoara, 300230
About this study
Official title: A 6-week, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
- 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 1.5 mg/d | Experimental | Cariprazine capsules, oral administration, once daily. Receives: Drug: Cariprazine |
| Cariprazine 4.5 mg/d | Experimental | Cariprazine capsules, oral administration, once daily. Receives: Drug: Cariprazine |
| Placebo | Placebo comparator | Matching placebo capsules, oral administration, once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in PANSS total score at Week 6
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start6 Jun 2019
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gedeon Richter Plc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817502
- Sponsor's protocol ID
- RGH-MD-20
- Other IDs
- 2018-004006-26, 2018
- Status last verified
- Oct 2025
- First submitted
- 24 Jan 2019
- Last updated
- 8 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Gedeon Richter will share de-identified patient-level data and study-level data for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. For more information please contact ra.ctarichter@richter.hu.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-week, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
- ClinicalTrials.gov ID
- NCT03817502
- Acronym / sponsor ID
- RGH-MD-20
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Gedeon Richter Plc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cariprazine 1.5 mg/d | Experimental | Drug: CariprazineCariprazine capsules, oral administration, once daily. |
| Cariprazine 4.5 mg/d | Experimental | Drug: CariprazineCariprazine capsules, oral administration, once daily. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo capsules, oral administration, once daily. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- DSM-5 primary diagnosis of schizophrenia.
- Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician.
- PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2).
- CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2).
Key exclusion criteria (3 listed)
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
- Diagnosis of intellectual disability (IQ < 70).
- Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 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 1.5 mg/d, Cariprazine 4.5 mg/d |
| PlaceboMatching placebo capsules, oral administration, once daily. | Drug | Placebo |
Primary outcome
Change from baseline in PANSS total score at Week 6
Time frame: Baseline to Week 6
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: Yes. Gedeon Richter will share de-identified patient-level data and study-level data for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. For more information please contact ra.ctarichter@richter.hu.
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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.
57 sites in 8 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 Gedeon Richter Plc. at 57 sites in 8 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Russia, United States, Mexico, Ukraine, Colombia and 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Balázs Lázár (+36 1 432 6437, RA.ctaRichter@richter.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in PANSS total score at Week 6 (time frame: Baseline to Week 6). 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 8 Oct 2025.