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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 study about?

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.

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 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 treatment duration

The study is conducted over a period of two years.

Regular assessments are performed to monitor safety and tolerability.

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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara Timisoara Romania
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Central Institute of Mental Health Mannheim Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Multiprofile Hospital For Active Treatment – Targovishte AD Targovishte Bulgaria
Mxhmkwl Cxufxa Sbuzouufs Eqhv Varna Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
14.06.2024
Germany Germany
Not recruiting
14.06.2024
Romania Romania
Not recruiting
14.06.2024

Trial locations

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.

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 ID:
2024-513222-30-00
Protocol code:
RGH-188-203
Trial Phase:
Therapeutic confirmatory (Phase III)

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