2-year, Multicentre, Open-label, Flexible-dose Study to Evaluate the Safety and Tolerability of Cariprazine in the Treatment of Adolescent Patients with Schizophrenia
Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves. Finding safe and effective treatments for teenagers can be challenging, as their bodies and brains are still growing. This clinical trial is testing a medicine called cariprazine, also known by the brand name Reagila. The study will follow teenagers aged 13 to 17 for up to two years. Because it is an open-label study, both doctors and families will know which medicine is being taken. The dose can be adjusted to find what works best. Doctors will monitor the young people closely with regular check-ups, blood tests, heart tracings, and mood reviews. The main goal is to check how safe the medicine is, how well it is tolerated, and whether it helps manage schizophrenia symptoms in this age group.
At a glance
What is this study about?
Schizophrenia is a condition that can cause people to see or hear things that are not there, hold beliefs that are not based in reality, or struggle with clear thinking and everyday tasks. When it begins during the teenage years, it can disrupt school, friendships, and home life. While treatments exist for adults, doctors need clear evidence to know which medicines are safe, gentle, and effective for younger people.
This trial is looking at cariprazine, a medicine already used for adults. Over two years, researchers want to see how teenagers respond to taking it over a longer period. The dose can be altered by the doctor to suit each person's needs, aiming for the best balance between helping symptoms and minimising unwanted effects.
Throughout the study, doctors will look closely at physical health and growth. Because teenagers are developing rapidly, the team will check things like body weight, hormone levels, sexual development, and heart health. They will also track changes in mood, daily functioning, and quality of life. The results could help doctors understand whether cariprazine is a helpful long-term option for young people living with schizophrenia.
Key takeaways
- Tests a medicine called cariprazine in teenagers aged 13 to 17 with schizophrenia.
- The study lasts for up to two years to see if the drug is safe and effective long-term.
- No placebo is used; everyone receives the active medicine.
- Doctors will closely monitor physical health, growth, hormones, and mood.
- Joining is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is designed specifically for adolescents aged between 13 and 17 years who have a confirmed diagnosis of schizophrenia. Both boys and girls can take part. Because the trial monitors how the body develops over two years, it is suited to teenagers who are able to attend regular hospital or clinic appointments.
People might not be able to join if they have certain other medical conditions, a history of severe physical illness, or are taking medications that cannot be safely combined with cariprazine. Pregnant or breastfeeding teens will also be unable to take part.
A doctor from the study team will carry out a thorough health check with each young person and their parent or guardian to make sure joining the trial is safe and appropriate for them.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Aged between 13 and 17 years old.
- Diagnosed with schizophrenia.
- Able to attend regular hospital or clinic appointments for two years.
- Willing to take a daily capsule as directed by the doctor.
- Have a parent or legal guardian who supports taking part in the trial.
What does participation involve?
Taking part in the study lasts for up to two years. Participants will take cariprazine capsules once a day by mouth, starting at a low dose that may be increased or decreased depending on how they feel. Regular clinic visits will be required throughout the trial.
During these appointments, the medical team will carry out routine health checks. These include measuring height, weight, and blood pressure, taking heart tracings (ECGs), and doing standard blood tests to check blood sugar and hormone levels. Doctors will also check physical development, ask about side effects, and use friendly questionnaires to see how the young person is thinking, feeling, and coping with day-to-day life. Support will be available at every step, and parents or guardians will be involved throughout.
Potential risks and benefits
Locations (3)
- —UnverifiedRomania
- —UnverifiedBulgaria
- —UnverifiedGermany
Common questions
What is an 'open-label' study?
Open-label means that everyone involved—including you, your family, and your doctors—will know exactly which medicine and dose you are taking. There is no dummy drug (placebo) used in this trial.
Will taking part cost anything?
No, the study medication and all study-related tests are provided free of charge. Travel expenses to attend clinic visits are often reimbursed.
Can the dose of medicine be changed?
Yes. The study is 'flexible-dose', which means the study doctor can adjust the dose to help find the right balance for symptom relief while keeping side effects low.
Do parents or guardians need to give permission?
Yes. Because participants are under 18, a parent or legal guardian must give informed consent, and the teenager must also agree (give assent) to take part.
What happens if we want to stop taking part?
You can leave the study at any point. Your medical team will help you safely stop the study medication and transition back to your usual mental health care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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