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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT01807403
Eligibility Criteria:
Inclusion criteria :
* Age 18 - 60
* OCD according to DSM IV, at least 5 years since diagnosis
* Severe OCD responsible for a clinically significant and objective alteration of psychosocial functioning and suffering: YBOCS score\>25, CGI score \>= 4 and EGF score \<= 40
* Resistance of OCD to at least 3 antidepressants from the serotonin reuptake inhibitors category, including clomipramine, given for at least 12 weeks with doses of at least 80mg/d for fluoxetine, 300mg/d for fluvoxamine, 200mg/d for sertraline, 60mg/d for paroxetine and citalopram, 250mg/d for clomipramine). Plus resistance to each of these 3 antidepressant associated first to risperidone or pimozide for a month then to Lithium carbonate, clonazepam, buspirone or pindolol for a month
* Resistance to at least 2 behavioural and cognitive therapies conducted by as many different specialists, following validated protocols (e.g. exposition and prevention of response)
* Oral and written knowledge of French
* Social security coverage
* Written consent of the patient after clear description of the study
Exclusion criteria :
* cognitive alteration with PM38 score \< IQ85
* Other axis 1 disorder according to DSM IV, excepted, global anxiety disorder, social phobia, nicotine dependance, and antecedent of major depressive episodes
* suicidal risk \>=2 on item 10 of MADRS (Montgomery Asberg Depression Rating Scale)
* Personality disorder (axis 2 of DSM IV assessed using the SCID II)
* Contra indication to MRI, abnormal brain MRI, other severe intercurrent disease
* Fertile woman without adequate contraception
* Pregnancy
* Forced psychiatric hospitalisation
* Any kind of legal protection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01807403
Study Brief:
Protocol Section:
NCT01807403