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RECRUITINGINTERVENTIONAL

Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this randomized, sham-controlled study is to evaluate the effectiveness of DBS therapy in individuals suffering from severe OCD and to investigate DBS treatment with functional \[18F\]FDG-Brain-PET.

Who May Be Eligible (Plain English)

Who May Qualify: - a score of 25 or higher on the Yale-Brown Obsessive Compulsive Scale - previous failure to respond to at least two medication trials with serotonin reuptake inhibitors at or, if tolerated, beyond the FDA maximum recommended dose for a minimum duration over at least ten weeks each. - at least one trial with tricyclic medication at or, if tolerated, beyond the FDA maximum recommended dose for a minimum duration over at least ten weeks each. - at least one trial of augmentation with antipsychotic medication, lithium, a benzodiazepine or buspirone - at least on trial of psychotherapy (cognitive behavioral therapy or comparable techniques) for at least 20 sessions - ability to provide written willing to sign a consent form Who Should NOT Join This Trial: - any history of current or past psychotic disorder - a manic episode within the preceding three years - any current clinically significant medical or neurological disorder, that is a contraindication against DBS - any disease that could lead to an altered glucose reactivity (e.g. diabetes) - any clinically significant preoperative MRI abnormality or inability to undergo presurgical MRI - current or unstable remitted substance abuse or dependence except nicotine - pregnancy or high risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception - Any current severe personality disorder except comorbid anankastic personality disorder - Inability to follow the study protocol or adhere to operational requirements - Current and unstable suicidality Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * a score of 25 or higher on the Yale-Brown Obsessive Compulsive Scale * previous failure to respond to at least two medication trials with serotonin reuptake inhibitors at or, if tolerated, beyond the FDA maximum recommended dose for a minimum duration over at least ten weeks each. * at least one trial with tricyclic medication at or, if tolerated, beyond the FDA maximum recommended dose for a minimum duration over at least ten weeks each. * at least one trial of augmentation with antipsychotic medication, lithium, a benzodiazepine or buspirone * at least on trial of psychotherapy (cognitive behavioral therapy or comparable techniques) for at least 20 sessions * ability to provide written informed consent Exclusion Criteria: * any history of current or past psychotic disorder * a manic episode within the preceding three years * any current clinically significant medical or neurological disorder, that is a contraindication against DBS * any disease that could lead to an altered glucose reactivity (e.g. diabetes) * any clinically significant preoperative MRI abnormality or inability to undergo presurgical MRI * current or unstable remitted substance abuse or dependence except nicotine * pregnancy or high risk of becoming pregnant during study duration (desire to have children) and refusal to utilize a proper method of contraception * Any current severe personality disorder except comorbid anankastic personality disorder * Inability to follow the study protocol or adhere to operational requirements * Current and unstable suicidality

Treatments Being Tested

DEVICE

Implantation of a DBS therapy system

The system is called "Reclaim DBS Therapy for OCD" und is marketed by Medtronic (Minneapolis, Minnesota). It has a HDE status by the FDA. The system consists of two quadripolar electrodes (Medtronic Reclaim DBS) as well as a generator (Medtronic Activa PC), which will be implanted into a subcutaneous pocket below the clavicula.

Locations (1)

Medical University of Vienna, Department of Psychiatry and Psychotherapy
Vienna, Vienna, Austria