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Tests treatment safety and results for Schizophrenia
Official title Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
ClinicalTrials.gov ID: NCT03817502
What this study is testing
What is Cariprazine?
Cariprazine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for schizophrenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and safety of cariprazine in the treatment of schizophrenia in the adolescent population.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 17
You may be able to join if
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Culver City, California, United States
- Atlanta, Georgia, United States
- Bloomfield Hills, Michigan, United States
- Flowood, Mississippi, United States
- Buffalo, New York, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- The Woodlands, Texas, United States
- Sofia, Bulgaria
- Targovishte, Bulgaria
- Barranquilla, Colombia
- Bello, Colombia
- Bogotá, Colombia
- Pereira, Colombia
- Culiacán, Mexico
- Durango, Mexico
- Guadalajara, Mexico
- Guanajuato City, Mexico
- Mérida, Mexico
- Monterrey, Mexico
+ 27 more site(s).
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, 13 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Culver City, California, United States; Atlanta, Georgia, United States; Bloomfield Hills, Michigan, United States; Flowood, Mississippi, United States; Buffalo, New York, United States; New York, New York, United States and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.