Obsessive-Compulsive Disorder
Conditions
Keywords
Obsessive-Compulsive Disorder, Deep brain stimulation, Subthalamic nucleus, Caudate nucleus, Nucleus accumbens
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 (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly. This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.
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 (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly. Therefore, bilateral subthalamic and caudate electrodes will be implanted in severe OCD patients. Efficacy of stimulation at the different targets will be assessed using a double-blind randomised crossover design.
Interventions
PROCEDUREDeep brain stimulation
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of symptoms after each phase | 3 months | Severity as measured by the Yale-Brown Obsession and Compulsion scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of symptoms after each phase | month 0 | Severity as measured by the Yale-Brown Obsession and Compulsion scale |
Countries
France
Outcome results
None listed