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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT05064527
Eligibility Criteria:
Inclusion Criteria:
* OCD (ICD-10 F42) as the primary or secondary diagnosis, verified with a semi-structured psychopathological interview using K-SADS-PL.
* CY-BOCS \> 7: mild (8-15), moderate (16-23), severe (24-31), extreme (32-40)
* A psychiatrist determined that the child is eligible for care within psychiatry for their primary diagnosis.
* Patient is age 8 through 17 years (both inclusive).
* Signed informed consent.
Exclusion Criteria:
* Participation in other OCD trials.
* Comorbid illness that contraindicates trial participation: pervasive developmental disorder not including Asperger's syndrome (ICD-10 F84.0-84.4 + F84.8-84.9)), schizophrenia/paranoid psychosis (ICD-10 F20-25 + F28-29), mania or bipolar disorder (ICD-10 F30 and F31), depressive psychotic disorders (F32.3 + F33.3), substance dependence syndrome (ICD-10 F1x.2).
* Intelligence Quotient \<70.
* Any condition (e.g. allergies, eczema, hypersensitivity due to Asperger's syndrome) that would prevent the child or parent from wearing a wristband biosensor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT05064527
Study Brief:
Protocol Section:
NCT05064527