NCT05577598 Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder
| NCT ID | NCT05577598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Obsessive-Compulsive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 8 participants in total. It began in 2022-04-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Christoph Kraus, MD PhD
PRINCIPAL INVESTIGATOR
Medical University of Vienna, Department of Psychiatry and Psychotherapy
Frequently Asked Questions
Who can join the NCT05577598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obsessive-Compulsive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05577598 currently recruiting?
Yes, NCT05577598 is actively recruiting participants. Contact the research team at christoph.kraus@muv.ac.at for enrollment information.
Where is the NCT05577598 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT05577598 clinical trial?
NCT05577598 is sponsored by Medical University of Vienna. The principal investigator is Christoph Kraus, MD PhD at Medical University of Vienna, Department of Psychiatry and Psychotherapy. The trial plans to enroll 8 participants.