Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT03817502
Eligibility Criteria:
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT03817502
Study Brief:
Protocol Section:
NCT03817502