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Comparison of DBS Targets in Obsessive-compulsive Disorder (PRESTOC2)

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Deep brain stimulation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Deep brain stimulation, Subthalamic nucleus, Caudate nucleus, Nucleus accumbens

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre d'investigation Clinique Pitié Salpêtrière

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Deep brain stimulation of subthalamic nucleus

Deep brain stimulation of caudate nucleus

Deep brain stimulation of nucleus accumbens

Arm Description

Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus

Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. Caudate nucleus stimulation

Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation.

Outcomes

Primary Outcome Measures

Severity of symptoms after each phase
Severity as measured by the Yale-Brown Obsession and Compulsion scale

Secondary Outcome Measures

Severity of symptoms after each phase
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Severity of symptoms after each phase
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Severity of symptoms after each phase
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Severity of symptoms after each phase
Severity as measured by the Yale-Brown Obsession and Compulsion scale

Full Information

First Posted
January 25, 2013
Last Updated
May 17, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01807403
Brief Title
Comparison of DBS Targets in Obsessive-compulsive Disorder
Acronym
PRESTOC2
Official Title
Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, Deep brain stimulation, Subthalamic nucleus, Caudate nucleus, Nucleus accumbens

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep brain stimulation of subthalamic nucleus
Arm Type
Experimental
Arm Description
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus
Arm Title
Deep brain stimulation of caudate nucleus
Arm Type
Experimental
Arm Description
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. Caudate nucleus stimulation
Arm Title
Deep brain stimulation of nucleus accumbens
Arm Type
Experimental
Arm Description
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation.
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation
Intervention Description
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Primary Outcome Measure Information:
Title
Severity of symptoms after each phase
Description
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Severity of symptoms after each phase
Description
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Time Frame
month 0
Title
Severity of symptoms after each phase
Description
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Time Frame
6 months
Title
Severity of symptoms after each phase
Description
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Time Frame
10 months
Title
Severity of symptoms after each phase
Description
Severity as measured by the Yale-Brown Obsession and Compulsion scale
Time Frame
14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Mallet, MD, PhD
Organizational Affiliation
Assitance Publique - Hopitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre d'investigation Clinique Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of DBS Targets in Obsessive-compulsive Disorder

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