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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01807403
First received: January 25, 2013
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Procedure: Deep brain stimulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Severity of symptoms after each phase [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Severity as measured by the Yale-Brown Obsession and Compulsion scale


Secondary Outcome Measures:
  • Severity of symptoms after each phase [ Time Frame: month 0 ] [ Designated as safety issue: No ]
    Severity as measured by the Yale-Brown Obsession and Compulsion scale

  • Severity of symptoms after each phase [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Severity as measured by the Yale-Brown Obsession and Compulsion scale

  • Severity of symptoms after each phase [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Severity as measured by the Yale-Brown Obsession and Compulsion scale

  • Severity of symptoms after each phase [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Severity as measured by the Yale-Brown Obsession and Compulsion scale


Enrollment: 8
Study Start Date: October 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep brain stimulation
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.There are three stimulation phases (subthalamic nucleus, caudate nucleus and nucleus accumbens) to be tested.
Procedure: Deep brain stimulation
Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Placebo Comparator: no intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807403

Locations
France
Centre d'investigation Clinique Pitié Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Luc Mallet, MD, PhD Assitance Publique - Hopitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01807403     History of Changes
Other Study ID Numbers: P081203
Study First Received: January 25, 2013
Last Updated: November 13, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Obsessive-Compulsive Disorder
Deep brain stimulation
Subthalamic nucleus
Caudate nucleus
Nucleus accumbens

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on July 24, 2014