MR-guided focused ultrasound bilateral capsulotomy for refractory bipolar depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for patients with treatment-resistant depression and OCD receiving interventional therapies

  This study is testing different treatments like ECT, TMS, and ketamine to see how they help people with treatment-resistant depression and OCD feel better.

  Recruiting University of Iowa · Iowa City, Iowa · NCT04480918

• EEG-Guided TMS for Adults With Depression

  This study tests whether delivering intermittent theta burst stimulation (iTBS) timed to brain waves using EEG can improve treatment for adults with major depressive disorder who have not responded to usual antidepressants.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07862205

• Ketamine plus behavioral activation therapy for treatment-resistant depression

  This study tests whether adding behavioral activation therapy to ketamine treatment helps adults with treatment-resistant depression feel better than ketamine alone.

  Recruiting Phase 2/3 The Royal's Institute of Mental Health Research · Ottawa, Ontario · NCT07801703

• SCC Deep Brain Stimulation for Bipolar Depression in Bipolar I Patients

  A small study tests whether deep brain stimulation of the subcallosal cingulate can help people with bipolar I depression who have not improved with other treatments, while monitoring brain signals to watch for manic switches.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT07745374

• EEG microstates and inflammatory biomarkers in older adults with major depression receiving ECT

  This study tests how ECT affects brain wave patterns and inflammatory markers in people 55 and older with major depression.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Bakırköy · NCT07740694

• Ketamine-assisted psychotherapy for treatment-resistant depression in adults

  This open-label program tests intravenous ketamine combined with psychotherapy to see if it helps adults with treatment-resistant depression.

  Recruiting Senz · Doorn, Utrecht · NCT07706478

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.