Study on the Effectiveness and Safety of Cariprazine for Adolescents (13-17 years) with Schizophrenia

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What is this study about?

This clinical trial is focused on studying the treatment of schizophrenia in adolescents aged 13 to 17 years. The treatment being tested is a medication called cariprazine, which is available in different doses: 0.5 mg, 1.5 mg, 3 mg, and 4.5 mg capsules. The study will compare the effects of cariprazine to a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how effective and safe cariprazine is for treating adolescents with schizophrenia. Participants will be randomly assigned to receive either cariprazine or a placebo for a period of six weeks. During this time, the participants will take the medication orally, which means by mouth, in the form of hard capsules. The study will monitor changes in symptoms and any side effects that may occur.

Throughout the study, participants will have regular check-ups to assess their health and the impact of the treatment. This includes monitoring vital signs, conducting physical examinations, and evaluating any changes in their condition. The study aims to provide valuable information on the use of cariprazine for treating schizophrenia in young people, helping to determine its potential benefits and risks.

1 joining the study

The study involves adolescents aged 13 to 17 years diagnosed with schizophrenia. Participation requires informed consent and assent.

Eligibility is confirmed through specific diagnostic criteria, including a primary diagnosis of schizophrenia and a certain score on the PANSS and CGI-S scales.

2 randomization and treatment assignment

Participants are randomly assigned to receive either the medication cariprazine or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the medication or placebo.

3 medication administration

Participants take the assigned treatment orally in the form of hard capsules. The dosages of cariprazine are either 1.5 mg or 4.5 mg per day, depending on the group assignment.

The treatment period lasts for 6 weeks.

4 monitoring and assessments

Throughout the study, participants undergo regular assessments to monitor the efficacy and safety of the treatment. This includes changes in the PANSS total score from baseline to Week 6.

Additional evaluations include clinical laboratory measures, vital signs, ECG, and various scales assessing symptoms and side effects.

5 completion of the study

At the end of the 6-week period, participants complete the study. Final assessments are conducted to evaluate the overall impact of the treatment.

Who Can Join the Study?

Must be between 13 to 17 years old.
Can be either an inpatient (staying in a hospital) or an outpatient (not staying in a hospital).
Must have a primary diagnosis of schizophrenia according to the DSM-5, which is a guide used by doctors to diagnose mental health conditions.
The diagnosis of schizophrenia must be confirmed by a test called K-SADS-PL, which is done by a trained clinician during the first visit.
Must have a PANSS score of 70 or higher. PANSS is a scale used to measure symptoms of schizophrenia. The score should also be 4 or higher (moderate) on at least 2 of the 5 specific symptoms: delusions, disorganized thinking, hallucinations, grandiosity, or suspiciousness.
Must have a CGI-S scale score of 4 or higher, which means being moderately ill. This is assessed during the first and second visits.

Who Cannot Join the Study?

Patients who are not between the ages of 13 to 17 years.
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 are not able to follow the study procedures or instructions.
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 substance abuse, which means using drugs or alcohol in a way that is harmful.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of severe allergic reactions.
Patients who have a family history of certain genetic disorders.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara	Timisoara	Romania
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Multiprofile Hospital For Active Treatment – Targovishte AD	Targovishte	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	22.02.2022
Romania	Not recruiting	22.02.2022

Trial locations

Investigated drugs:

Cariprazine is a medication being studied for its effectiveness and safety in treating adolescents aged 13 to 17 years with schizophrenia. It works by affecting certain chemicals in the brain that may become unbalanced in people with schizophrenia, helping to improve symptoms such as hallucinations, delusions, and disorganized thinking.

Investigated diseases:

Schizophrenia

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 negative symptoms such as reduced emotional expression and lack of motivation. The disorder typically emerges in late adolescence or early adulthood, but it can occur in younger individuals as well. Schizophrenia progresses with periods of exacerbation and remission, and its symptoms can vary widely among individuals. The exact cause of schizophrenia is not fully understood, but it is believed to involve a combination of genetic, brain chemistry, and environmental factors.

Trial ID:

2024-513194-44-00

Protocol code:

RGH-MD-20

NCT ID:

NCT03817502

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Cariprazine for Adolescents (13-17 years) with Schizophrenia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?