Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)
This study has been completed.
Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT00169377
First received: September 12, 2005
Last updated: July 22, 2008
Last verified: July 2008
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | July 22, 2008 | ||||
| Start Date ICMJE | October 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
YBOCS [ Time Frame: 2 three-month periods ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| 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 | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Obsessive Compulsive Disorder | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 16 | ||||
| Completion Date | May 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00169377 | ||||
| Other Study ID Numbers ICMJE | P030422 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | cecile Jourdain, Assistance Publique - Hôpitaux de Paris Delegation Research Clinical | ||||
| Study Sponsor ICMJE | Groupe Hospitalier Pitie-Salpetriere | ||||
| Collaborators ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Investigators ICMJE |
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| Information Provided By | Groupe Hospitalier Pitie-Salpetriere | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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