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Safety and Tolerability of Cariprazine in the Treatment of Adolescent Patients with Schizophrenia
EU CTIS ID: 2024-513222-30-00
What this study is testing
To evaluate the long-term safety and tolerability of cariprazine (1.5 mg/d to 6.0 mg/d) in the treatment of adolescents (13 to <18 years of age) with schizophrenia.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- In addition to the informed consent given by the parent(s) or legal representative assent of the patient must be obtained for participating in the study prior to any study related procedures
- Male or female patients must be 13 to <18 years of age at the time of obtaining the patient's informed consent or assent. Patients who turn 18 during RGH-MD-20 are permitted to continue in this trial. De novo patients are required to be <18 years of age at screening.
- Patients with a DSM-5 primary diagnosis of schizophrenia, which has been confirmed by the K-SADS-PL administered by a trained clinician
- PANSS total score ≤ 60 at Screening and Baseline
- Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8 and G14 at Screening and Baseline
- CGI-S score ≤ 4 at Screening and Baseline
You likely can't join if
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
- Patient has a history of meeting DSM-5 diagnosis for any substancerelated disorder (except caffeine- and tobaccorelated) within the 3 months before Screening
- Patient with acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypothyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease.
- Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 antipsychotic trials of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the drug's package insert)
- Patient requires concomitant treatment with moderate or strong cytochrome P450 (CYP) 3A4 inhibitors or inducers. If applicable and the patient's condition allows without risk, these drugs must be discontinued 7 days or at least 5 half-lives of the drug (whichever is longer) prior to Baseline (Visit 2).
See the full eligibility criteria
Who can join
- In addition to the informed consent given by the parent(s) or legal representative assent of the patient must be obtained for participating in the study prior to any study related procedures
- Male or female patients must be 13 to <18 years of age at the time of obtaining the patient's informed consent or assent. Patients who turn 18 during RGH-MD-20 are permitted to continue in this trial. De novo patients are required to be <18 years of age at screening.
- Patients with a DSM-5 primary diagnosis of schizophrenia, which has been confirmed by the K-SADS-PL administered by a trained clinician
- PANSS total score ≤ 60 at Screening and Baseline
- Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8 and G14 at Screening and Baseline
- CGI-S score ≤ 4 at Screening and Baseline
- Patients must agree to sexual abstinence or to use a highly effective contraceptive method (see Section 16.1) during the study and for 10 weeks after the last dose of the IMP. Male patients must agree to refrain from donating sperm during this period. Women using systematically acting hormonal contraceptives should add a second barrier method (e.g. male condom, diaphragm or cervical cap)
What rules you out
- Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
- Patient has a history of meeting DSM-5 diagnosis for any substancerelated disorder (except caffeine- and tobaccorelated) within the 3 months before Screening
- Patient with acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypothyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease.
- Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 antipsychotic trials of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the drug's package insert)
- Patient requires concomitant treatment with moderate or strong cytochrome P450 (CYP) 3A4 inhibitors or inducers. If applicable and the patient's condition allows without risk, these drugs must be discontinued 7 days or at least 5 half-lives of the drug (whichever is longer) prior to Baseline (Visit 2).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.