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New treatment option for Obsessive-Compulsive Disorder
Official title Glucose Consumption During Deep Brain Stimulation With Functional [18F]FDG-Brain-PET in Obsessive-Compulsive Disorder
ClinicalTrials.gov ID: NCT05577598
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, State of Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, State of Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.