Status:
COMPLETED
Comparison of DBS Targets in Obsessive-compulsive Disorder
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (...
Detailed Description
Deep brain stimulation has been proposed for severe and resistant obsessive-compulsive disorder (OCD). This electrical stimulation has been tested on, and shown to be effective at, different targets (...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01807403
Start Date
October 1 2010
End Date
February 1 2016
Last Update
May 18 2016
Active Locations (1)
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1
Centre d'investigation Clinique Pitié Salpêtrière
Paris, France, 75013