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New treatment option for Anorexia Nervosa (DSM-IV Revised Criteria)
Official title Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for Refractory Anorexia Nervosa With Comorbid Obsessive Compulsive Disorder or Major Depressive Disorder
ClinicalTrials.gov ID: NCT07113665
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the safety and initial clinical effectiveness of MRI-guided focused ultrasound (MRgFUS) thermal ablation (capsulotomy) in patients with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and major depressive disorder (MDD). The main questions it aims to answer are: 1.
- Phase 1: an early, usually small safety study
- 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 65
You may be able to join if
- Men and women ≥18 and ≤65 years of age, inclusive.
- Patients who are competent and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon.
- DSM-V diagnosis of Anorexia Nervosa, with co-morbid diagnosis of OCD and/or Major depressive disorder.
- Treatment refractoriness indicated by any of:
- Duration of illness more than 10 years with no more than three months of remission in terms of weight;
You likely can't join if
- Patients with unstable cardiac status [e.g. Unstable angina pectoris on medication, Patients with documented myocardial infarction within six months...
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size...
- Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding...
- Cerebrovascular disease (e.g. CVA within 6 months) or history of intracranial hemorrhage
- Untreated, uncontrolled sleep apnea
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to...
See the full eligibility criteria
- Men and women ≥18 and ≤65 years of age, inclusive.
- Patients who are competent and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon.
- DSM-V diagnosis of Anorexia Nervosa, with co-morbid diagnosis of OCD and/or Major depressive disorder.
- Treatment refractoriness indicated by any of:
- Duration of illness more than 10 years with no more than three months of remission in terms of weight;
- At least three attempts at expert hospital based treatment that were not successful or where there was no sustained response to treatment;
- A pattern of increased medical instability requiring at least two episodes of emergency/involuntary re-feeding and lasting at least two years;
- Ability to provide informed consent/competent to make medical decisions.
- Patients with unstable cardiac status [e.g. Unstable angina pectoris on medication, Patients with documented myocardial infarction within six months, Congestive heart failure requiring medication (other than diuretic)...
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR)
- Cerebrovascular disease (e.g. CVA within 6 months) or history of intracranial hemorrhage
- Untreated, uncontrolled sleep apnea
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused...
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- Are participating or have participated in another clinical trial in the last 30 days
- Patients unable to communicate with the investigator and staff.
- Presence of significant cognitive impairment
- History of psychosis on clinical evaluation.
- Patients with brain tumors already known or revealed on pretreatment MRI
- Currently pregnant (as determined by history and serum HCG) or lactating.
- Chemical abuse or dependence within the previous six months
- Presence of a metabolic pathology interfering with eating or digestion (e.g. diabetes).
- Body mass index (BMI) less than 13
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. 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.