Actively Recruiting
Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression
Led by Sunnybrook Health Sciences Centre · Updated on 2025-08-06
10
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 to 65 years of age, inclusive
- Competent and willing to give consent and able to attend study visits
- Diagnosed with Bipolar Disorder Type 1 or Type 2 according to DSM-5
- Minimum score of 20 on the Hamilton Depression Rating Scale when depressed for at least 2 weeks
- Treatment-resistant bipolar depression shown by at least two monotherapy treatments or one monotherapy plus one combination treatment for at least 4 weeks
- Able to provide informed consent and make medical decisions
You will not qualify if you...
- Unstable cardiac conditions such as unstable angina, recent myocardial infarction within 6 months, congestive heart failure requiring medication other than diuretics, use of anti-arrhythmic drugs, or severe hypertension (diastolic BP > 100 on medication)
- Contraindications for MRI including non-MRI compatible implanted metallic devices or size limitations
- Abnormal bleeding or coagulopathy (platelet count below 100,000 per cubic millimeter or abnormal INR)
- Cerebrovascular disease including stroke within 6 months or history of intracranial hemorrhage
- Untreated or uncontrolled sleep apnea
- Use of anticoagulant or antiplatelet therapy within 1 week before treatment or drugs increasing hemorrhage risk within 1 month
- Unable or unwilling to tolerate prolonged stationary supine position during treatment
- Participation in another clinical trial within the last 30 days
- Unable to communicate with study staff
- Significant cognitive impairment
- History of psychosis
- Catatonia, psychosis, or active suicidality at evaluation
- Known or new brain tumors on pretreatment MRI
- Pregnant or lactating women
- Chemical abuse or dependence within the previous 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Actively Recruiting
Research Team
N
Nir Lipsman, MD, PhD, FRCSC
CONTACT
A
Anusha Baskaran, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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