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 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT04967560
Eligibility Criteria:
Inclusion Criteria:
* aged 18-65 years old;
* a diagnosis of OCD based on The Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5);
* suffered from severe OCD symptoms over 5 years with substantial functional impairment;
* the Y-BOCS total score ≥ 25;
* met the criteria of treatment refractory. Treatment refractory is defined as failed 1) at least three adequate therapeutic trials of serotin reuptake inhibitors (SRIs), with clomipramine being one of the SRIs trials, 2) the use of at least two atypical antipsychotics as augmenting agents, 3) at least 20 sessions of therapist-guided cognitive-behavioral therapy while on a therapeutic dose of an SRIs. These patients have "failed" treatment by demonstrating \<25% reduction of Y-BOCS scores or, despite \>25% reduction in YBOCS score, by still experiencing significant impairment from their illness.
Exclusion Criteria:
* a history of current or past diagnosis of any psychosis according to DSM-5 except for OCD
* any clinical significant neurological disorder, traumatic brain injury, dementia, or medical illness
* any contradiction of neurosurgery
* any current or unstably remitted substance abuse or dependence
* women who are pregnant or preparing for pregnant
* severe suicide risk and tendency according to the investigators' judgements
* participate in any other clinical trials within three months (except for registered studies).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04967560
Study Brief:
Protocol Section:
NCT04967560