Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder
Recruiting · NCT05577598 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of Vienna
View the official record on ClinicalTrials.gov →Interventions studied
Implantation of a DBS therapy system
What this trial is about
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 can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Medical University of Vienna, Department of Psychiatry and Psychotherapy - Vienna, State of Vienna, Austria