Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

July 22, 2008

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

YBOCS [ Time Frame: 2 three-month periods ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00169377 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

MOCI, BABS, CGI, MADRS, HAD, GAF, SAS, neuropsychological tests, SAS-SR, Adverse event [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)

Official Title ^ICMJE

Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-Compulsive Disorders

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Obsessive Compulsive Disorder

Intervention ^ICMJE

Procedure: deep brain stimulation
Procedure: Off

Study Arms / Comparison Groups

Active Comparator: Stimulator on followed by off
Sham Comparator: Stimulator off followed by on

Publications *

Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chéreau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardès 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, Vérin 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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Severe obsessive-compulsive disorder

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00169377

Responsible Party

cecile Jourdain, Assistance Publique - Hôpitaux de Paris Delegation Research Clinical

Study ID Numbers ^ICMJE

P030422

Study Sponsor ^ICMJE

Groupe Hospitalier Pitie-Salpetriere

Collaborators ^ICMJE

Assistance Publique - Hôpitaux de Paris

Investigators ^ICMJE

Principal Investigator:

Luc Mallet, MD, PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Groupe Hospitalier Pitie-Salpetriere

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP