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Completed

NCT Number: NCT01807403

Comparison of DBS Targets in 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre d'investigation Clinique Pitié Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Brain Stimulation

Procedure

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

Primary outcomes

  1. Severity of symptoms after each phase

    Time frame: 3 months

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

Secondary outcomes

  1. Severity of symptoms after each phase

    Time frame: month 0

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

  2. Severity of symptoms after each phase

    Time frame: 6 months

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

  3. Severity of symptoms after each phase

    Time frame: 10 months

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

  4. Severity of symptoms after each phase

    Time frame: 14 months

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.

Acronym: PRESTOC2

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Mar 8, 2013
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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