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Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 years of age) with Schizophrenia
EU CTIS ID: 2024-513194-44-00
What this study is testing
To evaluate the efficacy of cariprazine 1.5 mg/d and cariprazine 4.5 mg/d compared to placebo in the treatment of adolescents (aged 13 to 17 years) 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
- Inpatients or outpatients, 13 to 17 years of age, inclusive, at the time of obtaining the informed consent and assent
- DSM-5 primary diagnosis of schizophrenia
- Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician.
- PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2).
- CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2)
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
- Diagnosis of intellectual disability (IQ < 70)
- Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Visit 1.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Colombia
- Russian Federation
- Serbia
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.
Where is this trial taking place?
Study sites include Mexico; Colombia; Russian Federation; Serbia. Enter your location above to see the nearest site and check your eligibility.
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.