Obsessive Compulsive Disorder Clinical Trial
Official title:
Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-compulsive Disorders
Verified date | March 2018 |
Source | Groupe Hospitalier Pitie-Salpetriere |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | May 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Severe obsessive-compulsive disorder Exclusion Criteria: - Contraindication to magnetic resonance imaging (MRI) - Severe cognitive or behavioral disorders |
Country | Name | City | State |
---|---|---|---|
France | Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière | Paris | |
France | Saint-Anne | Paris |
Lead Sponsor | Collaborator |
---|---|
Marie-laure Welter | Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Yale-Brown-Obession and Compulsion Scale (YBOCS) | YBOCS | 2 three-month periods | |
Secondary | Global assessment of function (GAF) | GAF | 10 month follow-up but 2 3-month period for the cross-over | |
Secondary | Clinical Global Impression(CGI) | CGI | 10 month follow-up but 2 3-month period for the cross-over | |
Secondary | Montgomery and Asberg Depression Rating scale (MADRS) | MADRS | 10 month follow-up but 2 3-month period for the cross-over | |
Secondary | Hospital Anxiety Depression scale (HAD-S) | HAD-S | 10 month follow-up but 2 3-month period for the cross-over | |
Secondary | Sheehan Disability Scale (SDS) | SDS | 10 month follow-up but 2 3-month period for the cross-over | |
Secondary | Brief Scale for Anxiety (BABS) | BABS | 10 month follow-up but 2 3-month period for the cross-over | |
Secondary | Social Adjustment scale self-report (SAS-SR) | SAS-SR | 10 month follow-up but 2 3-month period for the cross-over | |
Secondary | neuropsychological tests | STROOP, apathy scales | 10 month follow-up but 2 3-month period for the cross-over | |
Secondary | adverse event | adverse event | 10 month follow-up but 2 3-month period for the cross-over | |
Secondary | Yale-Brown-Obession and Compulsion Scale (YBOCS) | observational follow-up at 22 month, 34 month and 46 month | ||
Secondary | Global assessment of function (GAF) | observational follow-up at 22 month, 34 month and 46 month | ||
Secondary | Clinical Global Impression(CGI) | observational follow-up at 22 month, 34 month and 46 month | ||
Secondary | Montgomery and Asberg Depression Rating scale (MADRS) | observational follow-up at 22 month, 34 month and 46 month | ||
Secondary | Hospital Anxiety Depression scale (HAD-S) | observational follow-up at 22 month, 34 month and 46 month | ||
Secondary | Sheehan Disability Scale (SDS) | observational follow-up at 22 month, 34 month and 46 month | ||
Secondary | Social Adjustment scale self-report (SAS-SR) | observational follow-up at 22 month, 34 month and 46 month | ||
Secondary | Quality of life (SF-36) | observational follow-up at 22 month, 34 month and 46 month | ||
Secondary | neuropsychological tests | observational follow-up at 22 month, 34 month and 46 month | ||
Secondary | adverse event | observational follow-up at 22 month, 34 month and 46 month | ||
Secondary | Stimulation parameters | observational follow-up at 22 month, 34 month and 46 month |
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