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 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT02450695
Eligibility Criteria:
Inclusion Criteria:
* Patients with a primary diagnosis of OCD (DSM 5) according to the MINI
* Y-BOCS score of ≥20
* History of treatment-resistant OCD, established by a trained psychiatrist with extensive expertise in the OCD field. Treatment-resistance will be defined as non-response to at least two SRIs trials (clomipramine, fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram).
Exclusion Criteria:
* Any additional current psychiatric comorbidity, except for mild depressive and anxious symptoms
* A lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition
* Serious suicide risk
* Episodic OCD
* Illness duration less than two years
* Hospitalization in the last 6 months
* Pharmacological treatment changes in the last 3 months
* The inability to receive rTMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives)
* Any major medical disease
* Pregnancy or nursing of an infant
* The inability or refusal to provide informed consent
* Prior TMS exposure (in order to reduce the risk of unblinding).
No psychotherapy and/or pharmacological treatment changes will be allowed during the study period. Pharmacologically treated patients should be on constant medications for at least 2 weeks before entering the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02450695
Study Brief:
Protocol Section:
NCT02450695