MR-guided focused ultrasound bilateral capsulotomy for refractory bipolar depression
Phase I Trial of Magnetic Resonance-Guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression
This will try MR-guided focused ultrasound capsulotomy to see if it helps adults with treatment-resistant bipolar depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07108257 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, nonrandomized Phase I study delivering MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy targeted to the anterior limb of the internal capsule. Ten adults with treatment-resistant bipolar depression at Sunnybrook will undergo the procedure and be followed for safety, symptom change, and quality of life. Participants complete standardized rating scales (HAMD, BDI, BAI, YMRS, YBOCS, C-SSRS) and the QLESQ before treatment and at multiple visits over 24 months. The study emphasizes safety and initial effectiveness signals with a 2-month pre-treatment baseline and 24 months of post-treatment follow-up.
Who should consider this trial
Good fit: Adults aged 18–65 with a DSM-5 diagnosis of Bipolar I or II who are currently in a depressive episode (HAMD ≥20) and meet criteria for treatment-resistant bipolar depression, who can provide informed consent and attend follow-up visits, are ideal candidates.
Not a fit: Patients outside the 18–65 age range, those who do not meet the treatment-resistance criteria, or those with contraindications such as unstable cardiac conditions, inability to undergo MRI/MRgFUS, active mania or uncontrolled psychosis, or inability to consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this procedure could offer a durable treatment option that reduces depressive symptoms and improves quality of life for people with treatment-resistant bipolar depression.
How similar studies have performed: MRgFUS capsulotomy and related lesioning approaches have shown promising early results for treatment-resistant OCD and major depression, but application specifically to bipolar depression is novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men and women ≥18 and ≤65 years of age, inclusive. 2. Patients who are competent and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon. 3. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of Bipolar Disorder, Type 1 or Type 2. 4. 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). 5. 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. 6. Ability to provide informed consent/competent to make medical decisions. Exclusion Criteria: Patients with unstable cardiac status \[e.g. Unstable angina pectoris on medication, Patients with documented myocardial infarction within six months, Congestive heart failure requiring medication (other than diuretic), Patients on anti-arrhythmic drugs, Severe hypertension (diastolic BP \> 100 on medication)\] 2. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. 3\. 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. 5\. 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. 7\. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment. 8\. Are participating or have participated in another clinical trial in the last 30 days. 9\. 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. 14\. Chemical abuse or dependence within the previous six months
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Nir Lipsman, MD, PhD, FRCSC
- Email: Nir.Lipsman@sunnybrook.ca
- Phone: (416)-480-6954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.