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New hope for teens with schizophrenia? drug trial underway

NCT ID NCT03817502

Disease control Sponsor: Gedeon Richter Plc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether cariprazine, a daily medication, can safely reduce schizophrenia symptoms in teenagers aged 13 to 17. About 330 participants will receive either cariprazine or a placebo for 6 weeks. The main goal is to see if symptoms improve compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cariprazine (a medication taken by mouth once daily)
What this could lead to
If it works, this could provide a new treatment option for teenagers with schizophrenia, helping to reduce their symptoms.
What could go wrong
This is an early-stage Phase 3 trial with only 330 participants, so results may not apply to everyone. Cariprazine may cause side effects or not work better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlanta Behavioral Research, LLC

    WITHDRAWN

    Atlanta, Georgia, 30338, United States

  • Atlanta Center for Medical Research

    COMPLETED

    Atlanta, Georgia, 30331, United States

  • BLIND Investigaciones SC

    SUSPENDED

    San Luis Potosí City, 78213, Mexico

  • Bloomfield Hills MI

    WITHDRAWN

    Bloomfield Hills, Michigan, 48302, United States

  • CIT Neuropsique

    SUSPENDED

    Monterrey, 64610, Mexico

  • Center for Medical Rehabilitation named after S.S. Mnukhin

    TERMINATED

    Saint Petersburg, 197022, Russia

  • Centro de Investigacion del Sitema Nervioso CISNE

    SUSPENDED

    Bogotá, 1111666, Colombia

  • Centro de Investigaciones y Proyectos en Nerurociencia. CIPNA. IPS. SAS.

    SUSPENDED

    Barranquilla, 080020, Colombia

  • Centro para la Medicina y de Asistencia Medica Especializada S.C.

    SUSPENDED

    Culiacán, 80230, Mexico

  • City Psychiatric Hospital #3 after I.I. Skvortsova-Stepanova

    TERMINATED

    Saint Petersburg, 197341, Russia

  • Clinic for psychiatry, KCV

    RECRUITING

    Novi Sad, 21000, Serbia

  • Clinic of Child Psychiatry St. Nikolas

    RECRUITING

    Sofia, 1431, Bulgaria

  • Clinic.Neuro.Psych.Child.Youth

    TERMINATED

    Belgrade, 11000, Serbia

  • Clinical Psychiatry Hospital #1 of Nizhniy Novgorod

    TERMINATED

    Nizhny Novgorod, 603155, Russia

  • Communal Institution of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital

    TERMINATED

    Lviv, 79021, Ukraine

  • Consultorio Medico En Psiquiatria de Niños y Adolescentes Hospital Aranda de la Parra

    SUSPENDED

    Guanajuato City, 37000, Mexico

  • Consultorio de Medicina Especializada del Sector Privado

    WITHDRAWN

    Guadalajara, 44690, Mexico

  • E.S.E. Hospital Mental de Antioquia

    SUSPENDED

    Bello, 051053, Colombia

  • Family Psychiatry of The Woodlands

    COMPLETED

    The Woodlands, Texas, 77381, United States

  • 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

    TERMINATED

    Saint Petersburg, 192019, Russia

  • GBUZ Samara Regional Clinical Psychiatric Hospital

    SUSPENDED

    Samara, 443016, Russia

  • Iecsi S.C.

    SUSPENDED

    Monterrey, 64310, Mexico

  • Institute for Mental Health

    TERMINATED

    Belgrade, 11000, Serbia

  • Instituto Colombiano Sistema Nervioso Clinica Monserrat

    SUSPENDED

    Bogotá, 250051, Colombia

  • Instituto de Informacion e Investigacion en Salud Mental AC

    SUSPENDED

    Monterrey, 64710, Mexico

  • Instituto de Investigacion Clinica AC

    SUSPENDED

    Durango, 34000, Mexico

  • Joint-Stock Company Scientific Centre of Personalized Medicine

    TERMINATED

    Moscow, 105082, Russia

  • Kazan State Medical University KSMU

    SUSPENDED

    Kazan', 420012, Russia

  • Kherson Regional Institution of Mental Care

    TERMINATED

    Kherson, 73488, Ukraine

  • LLC Clinic "Sto Let"

    TERMINATED

    Tomsk, 634014, Russia

  • LLC Podderzhka

    TERMINATED

    Stavropol, 355038, Russia

  • MHAT Targovishte

    RECRUITING

    Targovishte, 7700, Bulgaria

  • Manhattan Behavioral Medicine PLLC

    WITHDRAWN

    New York, New York, 10036, United States

  • Medical Care and Research S.A. de C.V.

    ACTIVE_NOT_RECRUITING

    Mérida, 97070, Mexico

  • Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko"

    TERMINATED

    Vinnytsia, 21018, Ukraine

  • Odesa Regional Medical Centre of Mental Health

    TERMINATED

    Odesa, 65006, Ukraine

  • Precise Research Centers

    WITHDRAWN

    Flowood, Mississippi, 39232, United States

  • ProScience Research Group

    COMPLETED

    Culver City, California, 90230, United States

  • Psynapsis Salud Mental SA

    SUSPENDED

    Pereira, 660003, Colombia

  • Regional Psychonevrological Hospital #3

    TERMINATED

    Ivano-Frankivsk, 76011, Ukraine

  • Regional Public Institution "Lipetsk Regional Psychoneurological Hospital"

    TERMINATED

    Lipetsk, 399083, Russia

  • SBHI Specialized Clinical Psychiatric Hospital 1

    TERMINATED

    Krasnodar, 350007, Russia

  • SBHI of Moscow Region "Central Clinical Psychiatric Hospital"

    TERMINATED

    Moscow, 127083, Russia

  • SI "Institution of Neurology, Psychiatry and Narcology NAMS of Ukraine"

    TERMINATED

    Kharkiv, 61068, Ukraine

  • SI Research Institute of Psychiatry of MoH of Ukraine

    TERMINATED

    Kyiv, 04108, Ukraine

  • Saint-Petersburg GUZ Psychiatric Hospital No.1 n.a. P.P. Kaschenko

    TERMINATED

    Saint Petersburg, 190121, Russia

  • Smolensk State Medical University

    SUSPENDED

    Smolensk, 214019, Russia

  • Socola Psychiatric Institute Iasi

    WITHDRAWN

    Iași, 700282, Romania

  • Spitalul Clinic de Urgenta Pentru Copii Louis Turcanu Clinica de Psihiatrie Copii Si Adolescenti

    RECRUITING

    Timișoara, 300230, Romania

  • State Budgetary Healthcare Institution "Saratov City Clinical Hospital #2 n.a. V.I. Razumovsky"

    TERMINATED

    Saratov, 410028, Russia

  • State Institution "Institute of Health Care for Children and Adolescents of the AMS of Ukraine

    TERMINATED

    Kharkiv, 61153, Ukraine

  • State Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"

    TERMINATED

    Arkhangelsk, 163530, Russia

  • State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary

    TERMINATED

    Roshchino, 188820, Russia

  • Stavropol Regional Psychiatric hospital #2

    TERMINATED

    Tonnel'nyy, 357034, Russia

  • UB Department of Psychiatry

    WITHDRAWN

    Buffalo, New York, 142515, United States

  • University of Cincinnati

    COMPLETED

    Cincinnati, Ohio, 45219, United States

  • Yaroslavl Regional Psychiatric Hospital

    TERMINATED

    Yaroslavl Region, 634009, Russia

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