- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01807403
Comparison of DBS Targets in Obsessive-compulsive Disorder (PRESTOC2)
Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Paris, France, 75013
- Centre d'investigation Clinique Pitié Salpêtrière
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deep brain stimulation of subthalamic nucleus
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus
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Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
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Experimental: Deep brain stimulation of caudate nucleus
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Caudate nucleus stimulation
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Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
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Experimental: Deep brain stimulation of nucleus accumbens
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation.
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Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of symptoms after each phase
Time Frame: 3 months
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of symptoms after each phase
Time Frame: month 0
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Severity as measured by the Yale-Brown Obsession and Compulsion scale
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month 0
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Severity of symptoms after each phase
Time Frame: 6 months
|
Severity as measured by the Yale-Brown Obsession and Compulsion scale
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6 months
|
Severity of symptoms after each phase
Time Frame: 10 months
|
Severity as measured by the Yale-Brown Obsession and Compulsion scale
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10 months
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Severity of symptoms after each phase
Time Frame: 14 months
|
Severity as measured by the Yale-Brown Obsession and Compulsion scale
|
14 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Luc Mallet, MD, PhD, Assitance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P081203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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