Comparison of DBS Targets in Obsessive-compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

— PRESTOC2  

Official title:

Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807403
• Other study ID #: P081203
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2013
• Last updated: May 17, 2016
• Start date: October 2010
• Est. completion date: February 2016

Study information

• Verified date: April 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Procedure:
• Deep brain stimulation
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.

Locations

Country	Name	City	State
France	Centre d'investigation Clinique Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of symptoms after each phase	Severity as measured by the Yale-Brown Obsession and Compulsion scale	3 months	No
Secondary	Severity of symptoms after each phase	Severity as measured by the Yale-Brown Obsession and Compulsion scale	month 0	No
Secondary	Severity of symptoms after each phase	Severity as measured by the Yale-Brown Obsession and Compulsion scale	6 months	No
Secondary	Severity of symptoms after each phase	Severity as measured by the Yale-Brown Obsession and Compulsion scale	10 months	No
Secondary	Severity of symptoms after each phase	Severity as measured by the Yale-Brown Obsession and Compulsion scale	14 months	No