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Study on the Safety and Tolerability of Cariprazine for Treating Schizophrenia in Adolescents Aged 13-17

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety and tolerability of a medication called Cariprazine in treating adolescents aged 13 to 17 who have been diagnosed with Schizophrenia. Schizophrenia is a mental health disorder that affects a person's ability to think, feel, and behave clearly. The medication being tested, Cariprazine, is taken in the form of hard capsules and is designed to help manage symptoms of schizophrenia. The study will explore how well adolescents tolerate the medication over a long period, with doses ranging from 1.5 mg to 6.0 mg per day.

The purpose of this study is to evaluate the long-term safety of Cariprazine in young patients with schizophrenia. Participants in the study will take the medication orally, meaning they will swallow the capsules. The study will last for up to two years, during which time the participants will be monitored regularly to assess their health and any side effects they may experience. This monitoring will include various health checks, such as blood tests and physical examinations, to ensure the safety of the participants.

Throughout the study, participants will be closely observed for any adverse events or changes in their health. The study aims to gather information on how the medication affects the participants' overall well-being and whether it helps in managing the symptoms of schizophrenia. By the end of the study, researchers hope to have a better understanding of the long-term effects of Cariprazine in treating adolescents with schizophrenia, which could contribute to improved treatment options for this condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    The study involves adolescent patients aged 13 to 17 years with a primary diagnosis of schizophrenia.

    Before starting, consent from a parent or legal representative is required, along with the patient's agreement to participate.

  2. Step 2

    Medication administration

    The medication used in the study is cariprazine, administered in capsule form.

    Dosages range from 1.5 mg to 6.0 mg per day, taken orally.

    The dosage is flexible and adjusted based on individual needs and responses.

  3. Step 3

    Treatment duration

    The study is conducted over a period of two years.

    Regular assessments are performed to monitor safety and tolerability.

  4. Step 4

    Safety and health assessments

    Primary assessments include monitoring for adverse events, checking vital signs, and conducting physical examinations.

    Laboratory tests are performed to measure various health indicators such as blood sugar levels and hormone levels.

  5. Step 5

    Effectiveness evaluations

    Effectiveness is measured using scales like the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impressions (CGI) scale.

    Additional health-related outcomes are assessed to evaluate the overall impact on quality of life.

Who can join the trial?

7 criteria

  • The patient must be between 13 and 17 years old. If they turn 18 during the study, they can still continue.
  • The patient must have a primary diagnosis of **schizophrenia**. This diagnosis should be confirmed by a special interview conducted by a trained clinician.
  • The patient must have a **PANSS total score** of 60 or less at the start of the study. PANSS is a scale used to measure symptoms of schizophrenia.
  • The patient must score 4 or less on specific items of the PANSS scale at the start of the study. These items are labeled P1, P2, P3, P6, P7, G8, and G14.
  • The patient must have a **CGI-S score** of 4 or less at the start of the study. CGI-S is a scale used to rate the severity of the patient's condition.
  • The patient and their parent(s) or legal representative must agree to participate in the study by giving their consent before any study-related procedures begin.
  • The patient must agree to either not engage in sexual activity or use a highly effective method of birth control during the study and for 10 weeks after the last dose of the study medication. Male patients must also agree not to donate sperm during this time. Women using hormonal birth control should add a second barrier method, like a condom.

Who cannot join the trial?

9 criteria

  • Patients who are not between 13 and 17 years old.
  • Patients who do not have a diagnosis of schizophrenia. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are taking medications that could affect the study results.
  • Patients who have a history of not following medical advice or treatment plans.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a serious risk of harming themselves or others.
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Investigated drugs

Cariprazine is a medication used in this clinical trial to treat adolescents with schizophrenia. The study aims to assess the long-term safety and tolerability of this medication in young patients. Cariprazine is an antipsychotic drug that helps manage symptoms of schizophrenia, such as hallucinations, delusions, and disorganized thinking. It works by affecting certain chemicals in the brain to help improve mood, thinking, and behavior.

What is already known about the treatment

Cariprazine – Cariprazine is administered orally in the form of capsules. It is currently being studied in clinical trials to assess its safety and tolerability for treating schizophrenia in adolescents aged 13 to 17. The main therapeutic indication for cariprazine is schizophrenia, a mental health disorder characterized by distorted thinking and perception. At the molecular level, cariprazine works by modulating the activity of dopamine and serotonin receptors in the brain, which are neurotransmitters involved in mood and behavior regulation. It is classified as an atypical antipsychotic medication.

Investigated diseases

Schizophrenia – Schizophrenia is a chronic mental health disorder that affects how a person thinks, feels, and behaves. It is characterized by episodes of psychosis, which may include hallucinations, delusions, and disorganized thinking. Individuals with schizophrenia may also experience reduced motivation, emotional flatness, and difficulties in social interactions. The onset of symptoms typically occurs in late adolescence or early adulthood. The progression of the disease can vary, with some individuals experiencing periods of remission and others having persistent symptoms. Schizophrenia requires ongoing management to help individuals lead fulfilling lives.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-513222-30-00Protocol codeRGH-188-203Estimated enrolment39 patientsSponsorGedeon Richter Plc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).