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

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

This study has been completed.

Study NCT00169377. Last updated on July 22, 2008. Information provided by Groupe Hospitalier Pitie-Salpetriere

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Obsessive Compulsive Disorder

Intervention ^†

Procedure: deep brain stimulation
Procedure: Off

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

October 2005

Completion Date

May 2007

Eligibility Criteria ^†

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 ^††

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00169377

Organization ID

P030422

Secondary IDs ^††

Study Sponsor ^†

Groupe Hospitalier Pitie-Salpetriere

Collaborators ^††

Assistance Publique - Hôpitaux de Paris

Investigators ^†

Principal Investigator:

Luc Mallet, MD, PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Groupe Hospitalier Pitie-Salpetriere

Verification Date

July 2008

First Received Date ^†

September 12, 2005

Last Updated Date

July 22, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.