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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01329133
Eligibility Criteria:
Inclusion Criteria:
* Age comprised between 18 and 60 years
* History of OCD for at least 5 years according to the DSM-IV-TR criteria and characterized by a "good insight", as determined by the BABS ("Brown Assessment of Beliefs Scale")
* Severe form of OCD, as evidenced by:
* a score ≥ 25 on the Y-BOCS
* a score \> 4 on the CGI scale
* a score =\< 40 on the GAF ("global assessment of functioning)
* Lack of therapeutic effects of at least 3 antidepressants selectively blocking serotonin reuptake (SSRI) at least 12 consecutive weeks at the maximal tolerated dose (up to 80 mg/day for fluoxetine, 300 mg/day for fluvoxamine, 200 mg/day for sertraline, 60 mg/day for paroxetine, 60mg/day for citalopram and 250 mg/day for clomipramine) prescribed alone and in combination for at least 1 month with: 1) risperidone or olanzapine or aripiprazole or quetiapine, 2) clomipramine
* Lack of therapeutic effects of behavioral therapy with two different therapists using conventional techniques primarily based on exposure with prevention of ritualized response
* Understand and accept the design and constraints of the present study
* Be a beneficiary or member of health insurance plan
* Provide written consent to the study after receiving clear information
Exclusion Criteria:
* Patient with cognitive impairment with a Mattis scale score ≤ 130
* Patient with other DSM-IV-TR axis I diagnoses (schizophrenia, bipolar, substance abuse or substance dependence), except for generalized anxiety disorder, social phobia or nicotine dependence
* Patient with high suicide risk, as indicated by a score ≥ 2 on the MADRS (item 10)
* Patient with personality disorder corresponding to the clusters A and B, as assessed with the SIDP-IV ("Structured Interview for DSM-IV Personality")
* Patient with contraindication for MRI scanning, abnormal brain MRI or serious intercurrent disease
* Patient with contraindication for surgery or anesthesia
* Patient currently treated with anticoagulant or antiplatelet drug
* Be a woman of childbearing age without effective contraception
* Be hospitalized under constraint
* Be under guardianship procedures
* Prohibition on participation in other research, apart from any other non-interventional research
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01329133
Study Brief:
Protocol Section:
NCT01329133