Clinical trial NCT00169377: Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)
Official title: Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-compulsive Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive compulsive disorder
deep brain stimulation
subthalamic nucleus
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2005-09-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Obsessive-compulsive disorder is a disabling and frequent disorder. In some patients, the medical treatment is ineffective. The pathophysiology of this disease is still unknown. Some data suggest that basal ganglia dysfunction could participate in the occurrence of OCD. The aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency stimulation in patients with severe OCD.


Eligibility criteria: Inclusion Criteria:

* Severe obsessive-compulsive disorder

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI)
* Severe cognitive or behavioral disorders

Primary outcomes:
measure: Yale-Brown-Obession and Compulsion Scale (YBOCS)
timeFrame: 2 three-month periods
Secondary outcomes:
measure: Global assessment of function (GAF)
timeFrame: 10 month follow-up but 2 3-month period for the cross-over
measure: Clinical Global Impression(CGI)
timeFrame: 10 month follow-up but 2 3-month period for the cross-over
measure: Montgomery and Asberg Depression Rating scale (MADRS)
timeFrame: 10 month follow-up but 2 3-month period for the cross-over
measure: Hospital Anxiety Depression scale (HAD-S)
timeFrame: 10 month follow-up but 2 3-month period for the cross-over
measure: Sheehan Disability Scale (SDS)
timeFrame: 10 month follow-up but 2 3-month period for the cross-over
measure: Brief Scale for Anxiety (BABS)
timeFrame: 10 month follow-up but 2 3-month period for the cross-over
measure: Social Adjustment scale self-report (SAS-SR)
timeFrame: 10 month follow-up but 2 3-month period for the cross-over
measure: neuropsychological tests
timeFrame: 10 month follow-up but 2 3-month period for the cross-over
measure: adverse event
timeFrame: 10 month follow-up but 2 3-month period for the cross-over
measure: Yale-Brown-Obession and Compulsion Scale (YBOCS)
timeFrame: observational follow-up at 22 month, 34 month and 46 month
measure: Global assessment of function (GAF)
timeFrame: observational follow-up at 22 month, 34 month and 46 month
measure: Clinical Global Impression(CGI)
timeFrame: observational follow-up at 22 month, 34 month and 46 month
measure: Montgomery and Asberg Depression Rating scale (MADRS)
timeFrame: observational follow-up at 22 month, 34 month and 46 month
measure: Hospital Anxiety Depression scale (HAD-S)
timeFrame: observational follow-up at 22 month, 34 month and 46 month
measure: Sheehan Disability Scale (SDS)
timeFrame: observational follow-up at 22 month, 34 month and 46 month
measure: Social Adjustment scale self-report (SAS-SR)
timeFrame: observational follow-up at 22 month, 34 month and 46 month
measure: Quality of life (SF-36)
timeFrame: observational follow-up at 22 month, 34 month and 46 month
measure: neuropsychological tests
timeFrame: observational follow-up at 22 month, 34 month and 46 month
measure: adverse event
timeFrame: observational follow-up at 22 month, 34 month and 46 month
measure: Stimulation parameters
timeFrame: observational follow-up at 22 month, 34 month and 46 month
Other outcomes:
Locations:
city: Bordeaux
country: France
city: Clermont-Ferrand
country: France
city: Grenoble
country: France
city: Nantes
country: France
city: Nice
country: France
city: Paris
country: France
facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Saint-Anne
city: Poitiers
country: France
city: Rennes
country: France
city: Toulouse
country: France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Luc Mallet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Jeune F, Verin M, N'Diaye K, Drapier D, Leray E, Du Montcel ST, Baup N, Pelissolo A, Polosan M, Mallet L, Yelnik J, Devaux B, Fontaine D, Chereau I, Bourguignon A, Peron J, Sauleau P, Raoul S, Garin E, Krebs MO, Jaafari N, Millet B; French Stimulation dans le trouble obsessionnel compulsif (STOC) study group. Decrease of prefrontal metabolism after subthalamic stimulation in obsessive-compulsive disorder: a positron emission tomography study. Biol Psychiatry. 2010 Dec 1;68(11):1016-22. doi: 10.1016/j.biopsych.2010.06.033. Epub 2010 Oct 16.
citation: Bourredjem A, Pelissolo A, Rotge JY, Jaafari N, Machefaux S, Quentin S, Bui E, Bruno N, Pochon JB, Polosan M, Baup N, Papetti F, Chereau I, Arbus C, Mallet L, du Montcel ST; French "Stimulation dans le Trouble Obsessionnel Compulsif (STOC)" Study Group. A video Clinical Global Impression (CGI) in obsessive compulsive disorder. Psychiatry Res. 2011 Mar 30;186(1):117-22. doi: 10.1016/j.psychres.2010.06.021. Epub 2011 Feb 12.
citation: 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.