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Obsessive-Compulsive DisorderPhase 3STOC2NCT01329133

Deep Brain Stimulation and Obsessive-compulsive Disorder

A Phase 3 study testing Deep Brain Stimulation (DBS) in people with Obsessive-Compulsive Disorder, run by University Hospital, Bordeaux at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Deep Brain Stimulation (DBS)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
14 sitesFrance
Study dates
4 Apr 2011to Apr 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites
  • Bordeaux University Hospital

    Bordeaux, 33000

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, 63003

  • Henri Mondor Hospital

    Créteil, 94010

  • Grenoble University Hospital

    Grenoble, 38043

  • Lille University Hospital

    Lille, 59037

  • Lyon University Hospital

    Lyon, 69229

  • Marseille University Hospital

    Marseille, 13385

  • Nice University Hospital

    Nice, 06202

  • Pitié-Salpêtrière Hospital

    Paris, 75651

  • Sainte-Anne Hospital

    Paris, 75674

  • Poitiers University Hospital

    Poitiers, 86021

  • Rennes University Hospital

    Rennes, 35033

  • Strasbourg University Hospital

    Strasbourg, 67091

  • Toulouse University Hospital

    Toulouse, 31059

Other trials in France

About this study

Official title: Treatment of Severe and Resistant Obsessive-compulsive Disorder by High-frequency Stimulation of the Ventral Striatum and the Subthalamic Nucleus

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.

Read the detailed description

Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition with an estimated lifetime prevalence of 2-3 % of the general population. It is generally characterized by a chronic course leading to a profound impairment in psychosocial functioning and to a marked deterioration in quality of life. Today, the well-established efficacy of antidepressants, acting preferentially by blocking serotonin reuptake, in addition to psychological treatments, have considerably changed the poor prognosis of the illness. However, both conventional therapeutic approaches failed to substantially alleviate obsessive-compulsive symptoms in 20-30% of cases. Deep brain stimulation, as a reversible and adjustable surgical procedure, has recently been introduced in the field of OCD, primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN) and leading to an approximately 40% or greater reduction in clinical symptom intensity from baseline levels in severely chronic and resistant 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 multicenter, parallel-group, randomized, single-blind trial over a 13-month follow-up period. For this purpose, a total population of 28 OCD patients who meet the currently used operational criteria for defining therapeutic resistance will be recruited. The surgical procedure will consist in the implantation of stimulation electrodes with four contacts on each lead, which are stereotactically and bilaterally implanted into the targeted brain structure under local anesthesia. Per-operative, single-unit electrophysiological recordings of the neuronal activity will be performed using five parallel microelectrodes and serving as guide for the implantation of both definitive electrodes. They will be connected to a battery powered pulse-generating device five days later under general anesthesia. Thereafter, psychiatric assessments including both the Y-BOCS ("Yale-Brow Obsessive-compulsive scale") and PI ("Padua Inventory") for measuring OCD symptom severity, the BAS ("Brief Anxiety Scale"), MADRS ("Montgomery and Asberg Depression rating Scale") and HAD ("Hospital Anxiety and Depression Scale") for determining anxiety and/or depressive symptom intensity, and the CGI ("Clinical Global Impression") rating scales for evaluating global symptom severity and treatment response will be performed every 3 months beyond the one-month postoperative free-stimulation period. This will be coupled with a large battery of neuropsychological tests exploring all executive functions in combination with precise medical records of side effects for appreciating safety/tolerability of DBS. A cost-effectiveness analysis, as a formal method of comparing DBS and classical therapeutic strategies with regard to their respective resource utilization (costs) and outcomes (effectiveness) will also be carried out. Therefore, the present study may contribute to highlight the special interest of DBS, as an effective, safe, well-tolerated and cost-relevant surgical approach for the management of resistant OCD.

Being tested
Deep Brain Stimulation (DBS)
Keywords
Deep brain stimulation (DBS), Obsessive compulsive disorder, ventral striatum, subthalamic nucleus
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep Brain Stimulation (DBS)Procedure or surgery

    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.

Study groups in NCT01329133
Study groupRoleWhat they receive
DBS of subthalamic nucleusActive comparatorNot described
Receives: Procedure: Deep Brain Stimulation (DBS)
DBS of ventral striatumActive comparatorNot described
Receives: Procedure: Deep Brain Stimulation (DBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Month 13 : one year after stimulation

Secondary outcomes (14)
  1. Remission as defined by a Y-BOCS score ≤ 16 at M13

    Measured: Month 13 : one year after stimulation

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

    Measured: End of surgical procedure (day 1)

  3. 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

    Measured: Every 3 months from Month 1 to Month 13

  4. Scores on neuropsychological tests exploring all executive functions

    Measured: Every 3 months from Month 1 to Month 13

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

    Measured: Every 3 months from Month 1 to Month 13

  6. Therapeutic response, as indicated by a 35% decrease or more in the Y-BOCS score and a score of 1 or 2 (very much or much improved) on the CGI improvement scale from M1 to M13

    Measured: Every 3 months from Month 1 to Month 13

  7. Percentage change in the Y-BOCS obsessive and compulsive subscores from M1 to M13

    Measured: Every 3 months from Month 1 to Month 13

  8. Percentage change in the overall Padua Inventory score, MADRS score, BAS score from M1 to M13

    Measured: Every 3 months from Month 1 to Month 13

  9. Percentage change in the total and depression and anxiety subscale scores on the HAD scale from M1 and M13

    Measured: Every 3 months from Month 1 to Month 13

  10. Ratings of functional disability and quality of life

    Measured: Every 3 months from Month 1 to Month 13

  11. Correlations between efficacy and anatomical positioning of both stimulation electrodes within the chosen brain target

    Measured: Every 3 months from Month 1 to Month 13

  12. cost comparison of therapeutic strategies

    cost comparison of thérapeutic strategies : classical versus surgical

    Measured: M-13 and M13 (one year after stimultaion)

  13. Cost / effectiveness ration

    Cost / effectiveness ratio : cost difference between therapeutic strategies and success rate of DBS

    Measured: M-13/ M13 (one year after stimulation)

  14. Cost-utility rati

    Cost-utility ratio based on SF-36 scores.

    Measured: every 3 months from month 1 to month 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2011 (estimated)
  2. Study start4 Apr 2011
  3. Primary completionApr 2019
  4. Study completionApr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01329133
Sponsor's protocol ID
CHUBX 2010/43
Acronym
STOC2
Status last verified
Feb 2020
First submitted
4 Apr 2011
Last updated
6 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19284243
  • 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.

    PubMed 19005196

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Deep Brain Stimulation (DBS) in people with Obsessive-Compulsive Disorder, run by University Hospital, Bordeaux at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Month 13 : one year after stimulation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01329133, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.

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