Deep Brain Stimulation and Obsessive-compulsive Disorder

NCT01329133 | Completed Phase 3 DMC

• 1 other identifier: CHUBX 2010/43
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 14

Brief Summary

Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition, which is classically treated by antidepressant medications in combination with psychotherapies. However, both these conventional therapeutic approaches fail to sufficiently improve obsessive-compulsive symptoms in 20-30% of cases. From these considerations, deep brain stimulation (DBS), as a reversible and adjustable surgical procedure, has recently been introduced in the field of resistant OCD. DBS currently uses electrodes with four contacts on each lead, which are bilaterally implanted into the chosen brain structure. DBS consists of the delivery of a high-frequency current through the quadripolar electrodes connected to a battery powered pulse-generating device. Several clinical investigations have shown that DBS, primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN), as brain sites of interest because of their particular involvement in the production of OCD symptoms, is able to produce an approximately 40% or greater reduction in clinical symptom intensity in severely chronic and incapacitating forms of OCD. These promising findings lead to propose a comparison of the efficacy, safety and tolerability of DBS choosing either the VS or STN as brain target by conducting a large controlled trial and including a medico-economic analysis for assessing the classical cost/efficacy ratio. In this way, the present study is expected to promote and highlight the importance of DBS, as an effective, safe, well-tolerated and cost-relevant surgical approach for the management of resistant OCD.

Conditions

Obsessive-Compulsive Disorder

Keywords

Deep brain stimulation (DBS); Obsessive compulsive disorder; ventral striatum; subthalamic nucleus

Outcome Measures

Primary Outcomes (1)

• Combination of three criteria (composite criterion), as follows: a. Y-BOCS score ≤ 16 / and b. Technical feasibility (each leads in the target) / and c. Safety, as assessed by any serial adverse event

  Month 13 : one year after stimulation

Secondary Outcomes (14)

• Remission as defined by a Y-BOCS score ≤ 16 at M13

  Month 13 : one year after stimulation

• Number of electrode contacts correctly located within the chosen brain target (0, 1 or 2)

  End of surgical procedure (day 1)

• Monitoring of psychological and somatic complaints made spontaneously by the patient over the course of the present trial, in combination to the semi-structured interview for collecting side effects

  Every 3 months from Month 1 to Month 13

• Scores on neuropsychological tests exploring all executive functions

  Every 3 months from Month 1 to Month 13

• Percentage change in the total Y-BOCS score from M1 to M13

  Every 3 months from Month 1 to Month 13

Study Arms (2)

DBS of subthalamic nucleus

ACTIVE COMPARATOR

Procedure: Deep Brain Stimulation (DBS)

DBS of ventral striatum

ACTIVE COMPARATOR

Procedure: Deep Brain Stimulation (DBS)

Interventions

Deep Brain Stimulation (DBS) PROCEDURE

In a first time: Implantation of DBS electrodes, stereotactically, in each hemisphere into the targeted brain structure under local anesthesia. In a second time (next week): installation of the deep brain neurostimulator and connection to the electrodes implanted under general anesthesia. And one month later: beginning of the stimulation.

DBS of subthalamic nucleus; DBS of ventral striatum

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age comprised between 18 and 60 years
• History of OCD for at least 5 years according to the DSM-IV-TR criteria and characterized by a "good insight", as determined by the BABS ("Brown Assessment of Beliefs Scale")
• Severe form of OCD, as evidenced by:
• a score ≥ 25 on the Y-BOCS
• a score \> 4 on the CGI scale
• a score =\< 40 on the GAF ("global assessment of functioning)
• Lack of therapeutic effects of at least 3 antidepressants selectively blocking serotonin reuptake (SSRI) at least 12 consecutive weeks at the maximal tolerated dose (up to 80 mg/day for fluoxetine, 300 mg/day for fluvoxamine, 200 mg/day for sertraline, 60 mg/day for paroxetine, 60mg/day for citalopram and 250 mg/day for clomipramine) prescribed alone and in combination for at least 1 month with: 1) risperidone or olanzapine or aripiprazole or quetiapine, 2) clomipramine
• Lack of therapeutic effects of behavioral therapy with two different therapists using conventional techniques primarily based on exposure with prevention of ritualized response
• Understand and accept the design and constraints of the present study
• Be a beneficiary or member of health insurance plan
• Provide written consent to the study after receiving clear information

You may not qualify if:

• Patient with cognitive impairment with a Mattis scale score ≤ 130
• Patient with other DSM-IV-TR axis I diagnoses (schizophrenia, bipolar, substance abuse or substance dependence), except for generalized anxiety disorder, social phobia or nicotine dependence
• Patient with high suicide risk, as indicated by a score ≥ 2 on the MADRS (item 10)
• Patient with personality disorder corresponding to the clusters A and B, as assessed with the SIDP-IV ("Structured Interview for DSM-IV Personality")
• Patient with contraindication for MRI scanning, abnormal brain MRI or serious intercurrent disease
• Patient with contraindication for surgery or anesthesia
• Patient currently treated with anticoagulant or antiplatelet drug
• Be a woman of childbearing age without effective contraception
• Be hospitalized under constraint
• Be under guardianship procedures
• Prohibition on participation in other research, apart from any other non-interventional research

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (14)

Bordeaux University Hospital

Bordeaux, 33000, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63003, France

Location

Henri Mondor Hospital

Créteil, 94010, France

Location

Grenoble University Hospital

Grenoble, 38043, France

Location

Lille University Hospital

Lille, 59037, France

Location

Lyon University Hospital

Lyon, 69229, France

Location

Marseille University Hospital

Marseille, 13385, France

Location

Nice University Hospital

Nice, 06202, France

Location

Pitié-Salpêtrière Hospital

Paris, 75651, France

Location

Sainte-Anne Hospital

Paris, 75674, France

Location

Poitiers University Hospital

Poitiers, 86021, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

Strasbourg University Hospital

Strasbourg, 67091, France

Location

Toulouse University Hospital

Toulouse, 31059, France

Location

Related Publications (2)

• Aouizerate B, Cuny E, Bardinet E, Yelnik J, Martin-Guehl C, Rotge JY, Rougier A, Bioulac B, Tignol J, Mallet L, Burbaud P, Guehl D. Distinct striatal targets in treating obsessive-compulsive disorder and major depression. J Neurosurg. 2009 Oct;111(4):775-9. doi: 10.3171/2009.2.JNS0881.

  PMID: 19284243 BACKGROUND

• Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.

  PMID: 19005196 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• BENARD Antoine, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

• Emmanuel CUNY, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Bruno AOUIZERATE, MD-PhD

  Charles Perrens hospital, Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 5, 2011
• Study Start: April 4, 2011
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

FR (14)