Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression

What this study is about

The goal of this clinical trial is to evaluate the safety and initial effectiveness of MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy in patients with treatment-resistant bipolar depression (TRBD).

Who can join (things the study team will check)

✅ 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.
• Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of Bipolar Disorder, Type 1 or Type 2.
• A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) when depressed (at least 2 weeks of major depression at the time the HAMD is conducted).
• Treatment refractory bipolar depression indicated by at least two recommended monotherapy treatments or at least one monotherapy treatment and another combination treatment. The minimum duration for being on either of these regimens should be 4 weeks.
• Ability to provide informed consent/competent to make medical decisions.

🚫 You may not be able to join if…

• 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 International Normalized Ratio) 4. Cerebrovascular disease (e.g. Cerebrovascular Accident within 6 months) or history of intracranial hemorrhage.
• Untreated, uncontrolled sleep apnea. 6. 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 ultrasound procedure.
• 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. 10. Presence of significant cognitive impairment 11. History of psychosis on clinical evaluation. 12. Catatonic or psychotic or actively suicidal on clinical evaluation. 12. Patients with brain tumors already known or revealed on pretreatment MRI. 13. Currently pregnant (as determined by history and serum Human Chorionic Gonadotropin) or lactating.
• Chemical abuse or dependence within the previous six months

Where this trial is running

• Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Who to contact

Nir Lipsman, MD, PhD, FRCSC · (416)-480-6954 · Nir.Lipsman@sunnybrook.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07108257.