Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

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

This research study is testing a medication called cariprazine (also known as Reagila) for teenagers aged 13 to 17 who have schizophrenia. The main goal is to see how well different doses of cariprazine work compared to a placebo (a pill with no medicine) in helping reduce schizophrenia symptoms over six weeks. Researchers will also be checking carefully for any side effects and looking at other health measures like blood tests, heart rate, and overall physical health. This is a "double-blind" study, meaning neither the participants nor their doctors will know whether they are receiving cariprazine or the placebo. This helps ensure the results are as fair and accurate as possible.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Gedeon Richter Plc.

Enrolment target

Start

30 Jul 2024

Adolescent Patients (13 to 17 years of age) with Schizophrenia

What is this study about?

This study is about a medicine called cariprazine, also known as Reagila, for young people between 13 and 17 years old who have schizophrenia. Schizophrenia is a brain disorder that can affect how a person thinks, feels, and behaves. Medicines are often an important part of managing the symptoms of schizophrenia.

The main aim of this study is to find out if cariprazine can help reduce the symptoms of schizophrenia in teenagers and if it’s safe for them to take. They will compare different strengths of cariprazine (0.5 mg, 1.5 mg, 3 mg, and 4.5 mg) with a dummy pill called a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps researchers understand if any changes in symptoms are truly due to the medicine or something else.

This is a type of study called a "Phase III" trial, which means the medicine has already been studied before and is now being tested on a larger group of people to confirm its effects and safety. The results of studies like this are very important for doctors and patients to decide on the best treatments.

Key takeaways

The study is testing a medicine called cariprazine for teens with schizophrenia.
It lasts about six weeks and compares cariprazine to a dummy pill (placebo).
Researchers will check if cariprazine helps with symptoms and is safe.
You won't know if you're taking the real medicine or the placebo.
Participation helps future treatments for schizophrenia.
You can stop taking part at any time.

Who may be eligible?

This study is specifically designed for young people aged between 13 and 17 years old who have been diagnosed with schizophrenia. Both boys and girls can take part in this research.

To be considered for this study, you would need to meet certain health requirements that the study doctors will check very carefully. These checks are in place to make sure the study is safe for everyone involved and that the results are reliable. It's important to remember that not everyone with schizophrenia will be able to join, as there are often specific medical criteria that need to be met.

Quick self-check

Are you between 13 and 17 years old?
Have you been diagnosed with schizophrenia?
Are you able to attend regular clinic appointments?
Are you comfortable with the possibility of receiving a placebo?
Are you willing to have regular health checks, including blood tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive either the study medicine (cariprazine) or a placebo in capsule form for six weeks. You would have regular visits to the clinic during this time. These visits would involve assessments to see how your symptoms are changing, checking your general health with blood tests, heart rate measurements, and physical examinations. You might also be asked questions about your mood, side effects you're experiencing, and how you're feeling overall. Some specific assessments would look at things like movements and growth. The total time you would be actively involved in taking the study medicine and having your health checked would be around six weeks.

Potential risks and benefits

Potential benefits could include an improvement in your schizophrenia symptoms if you receive the active medication. You would also be contributing to medical research that could help others with schizophrenia in the future. As with any medicine, there are potential risks and side effects, which the study team will explain in detail. These can range from mild to more serious, and your health will be closely monitored throughout the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

—
Romania
—
Bulgaria

Common questions

What is a placebo?

A placebo is a dummy pill that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers compare the effects of the active medicine fairly.

What does 'double-blind' mean?

It means that neither you nor your doctor will know whether you are taking the actual study medicine or the placebo. This helps make the study results more accurate.

How long will I be in the study?

You will be taking the study medicine or placebo and having your health checked for about six weeks.

Will I get to choose which medicine I take?

No, participants are randomly assigned to receive either one of the doses of cariprazine or the placebo, like drawing names out of a hat.

What happens if I start feeling worse during the study?

Your health and well-being will be closely monitored, and your study doctor will be there to help and support you throughout. You can also withdraw from the study at any time.