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