Treatment of Severe and Resistant Obsessive-compulsive Disorder by High-frequency Stimulation of the Ventral Striatum and the Subthalamic Nucleus

Status: Completed
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition, which is classically treated by antidepressant medications in combination with psychotherapies. However, both these conventional therapeutic approaches fail to sufficiently improve obsessive-compulsive symptoms in 20-30% of cases. From these considerations, deep brain stimulation (DBS), as a reversible and adjustable surgical procedure, has recently been introduced in the field of resistant OCD. DBS currently uses electrodes with four contacts on each lead, which are bilaterally implanted into the chosen brain structure. DBS consists of the delivery of a high-frequency current through the quadripolar electrodes connected to a battery powered pulse-generating device. Several clinical investigations have shown that DBS, primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN), as brain sites of interest because of their particular involvement in the production of OCD symptoms, is able to produce an approximately 40% or greater reduction in clinical symptom intensity in severely chronic and incapacitating forms of OCD. These promising findings lead to propose a comparison of the efficacy, safety and tolerability of DBS choosing either the VS or STN as brain target by conducting a large controlled trial and including a medico-economic analysis for assessing the classical cost/efficacy ratio. In this way, the present study is expected to promote and highlight the importance of DBS, as an effective, safe, well-tolerated and cost-relevant surgical approach for the management of resistant OCD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
France
Bordeaux University Hospital
Bordeaux
Clermont-Ferrand University Hospital
Clermont-ferrand
Henri Mondor Hospital
Créteil
Grenoble University Hospital
Grenoble
Lille University Hospital
Lille
Lyon University Hospital
Lyon
Marseille University Hospital
Marseille
Nice University Hospital
Nice
Pitié-Salpêtrière Hospital
Paris
Sainte-Anne Hospital
Paris
Poitiers University Hospital
Poitiers
Rennes University Hospital
Rennes
Strasbourg University Hospital
Strasbourg
Toulouse University Hospital
Toulouse
Time Frame
Start Date: April 4, 2011
Completion Date: April 2019
Participants
Target number of participants: 31
Treatments
Active Comparator: DBS of subthalamic nucleus
Active Comparator: DBS of ventral striatum
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov

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