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Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)
This study has been completed.
Study NCT00169377   Information provided by Groupe Hospitalier Pitie-Salpetriere
First Received: September 12, 2005   Last Updated: July 22, 2008   History of Changes

September 12, 2005
July 22, 2008
October 2005
 
YBOCS [ Time Frame: 2 three-month periods ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00169377 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)
Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-Compulsive Disorders

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.

 
Phase I, Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Obsessive Compulsive Disorder
  • Procedure: deep brain stimulation
  • Procedure: Off
  • Active Comparator: Stimulator on followed by off
  • Sham Comparator: Stimulator off followed by on
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.
 
Completed
16
May 2007
 

Inclusion Criteria:

  • Severe obsessive-compulsive disorder

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging (MRI)
  • Severe cognitive or behavioral disorders
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00169377
cecile Jourdain, Assistance Publique - Hôpitaux de Paris Delegation Research Clinical
P030422
Groupe Hospitalier Pitie-Salpetriere
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Luc Mallet, MD, PhD Assistance Publique - Hôpitaux de Paris
Groupe Hospitalier Pitie-Salpetriere
July 2008

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