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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04891367
Eligibility Criteria:
Inclusion Criteria:
* 13 to 17 years of age
* A primary diagnosis of OCD according to Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime version for DSM-IV (K-SADS-PL).
* Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)24 total score ≥ 16.
Exclusion Criteria:
* meet the criteria for an intellectual disability (IQ \< 70),
* meet the criteria for psychotic disorder according to DSM-5,
* meet the criteria for Asperger's, or Autistic syndrome with a Clinical Global Impression Scale - Severity (CGI-S) rating ≥ 4 or same or higher rating than CGI-S for OCD
* meet the criteria for PDD-NOS with a Clinical Global Impression Scale - Severity (CGI-S) rating ≥ 4 or same or higher rating than CGI-S for OCD
* meet the criteria for any co-occurring mental disorder according to the Diagnostic and statistical manual of mental disorders (DSM-5) with a CGI-S rating higher than CGI-S for OCD, indicating that OCD is not the primary treatment priority
* have been treated with CBT six months prior to inclusion,
* have been treated with (S)SRIs six months prior to inclusion (dose ≥50 mg),
* have inadequate Danish language proficiency or both parents have inadequate Danish language proficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT04891367
Study Brief:
Protocol Section:
NCT04891367