NCT01807403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

April 1, 2015

Enrollment Period

5.3 years

First QC Date

January 25, 2013

Last Update Submit

May 17, 2016

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive DisorderDeep brain stimulationSubthalamic nucleusCaudate nucleusNucleus accumbens

Outcome Measures

Primary Outcomes (1)

  • Severity of symptoms after each phase

    Severity as measured by the Yale-Brown Obsession and Compulsion scale

    3 months

Secondary Outcomes (4)

  • Severity of symptoms after each phase

    month 0

  • Severity of symptoms after each phase

    6 months

  • Severity of symptoms after each phase

    10 months

  • Severity of symptoms after each phase

    14 months

Study Arms (3)

Deep brain stimulation of subthalamic nucleus

EXPERIMENTAL

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

Procedure: Deep brain stimulation

Deep brain stimulation of caudate nucleus

EXPERIMENTAL

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

Procedure: Deep brain stimulation

Deep brain stimulation of nucleus accumbens

EXPERIMENTAL

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

Procedure: Deep brain stimulation

Interventions

Deep brain stimulationPROCEDURE

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

Deep brain stimulation of caudate nucleusDeep brain stimulation of nucleus accumbensDeep brain stimulation of subthalamic nucleus

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'investigation Clinique Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Luc Mallet, MD, PhD

    Assitance Publique - Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

March 8, 2013

Study Start

October 1, 2010

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 18, 2016

Record last verified: 2015-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)