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:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT07065669
Eligibility Criteria:
Inclusion Criteria:
1. outpatients
2. ages 13 - 17 years
3. meets current DSM-5 criteria for Obsessive Compulsive Disorder with screening CY-BOCS II score \> 16 (moderate to severe).
4. stable on chronic psychotropic medications and/or therapy for 8 weeks prior to the study and agreeable to continue throughout the study without changes.
5. participants may continue to take medications and record daily usage throughout the study.
6. capacity to provide informed assent and parent or legal guardian able to provide consent.
7. ability to tolerate clinical study procedures.
8. successfully complete the screening forms without any contraindications.
Exclusion Criteria:
1. Psychiatric: history of schizophrenia, bipolar disorder, substance/alcohol abuse disorder, current elevated suicide risk, prior psychosurgery, prior ECT.
2. Neurologic: severe neurocognitive disorder, seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, hydrocephalus, sequelae of meningitis, frank brain injury).
3. TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics; medications or systemic illness that predispose seizure risk; family history of 1st degree relative with seizure disorder.
4. Subjects with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension, malnutrition secondary to eating disorder).
5. Females who are pregnant or nursing (as determined by a questionnaire and pregnancy test).
6. Current and anticipated continued treatment with excluded medication (See prohibited list).
7. Inability to complete the research protocol as determined by the Principal Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT07065669
Study Brief:
Protocol Section:
NCT07065669