Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with treatment-resistant depression, which means their depression has not improved despite trying standard treatments like medications and therapy. The study is testing a technology called focused ultrasound, guided by MRI, to gently stimulate specific areas in the brain involved in mood regulation. The goal is to see if this approach is safe and if it might help improve depression symptoms.

People who may be eligible for this study are adults aged 18 to 65 who have been diagnosed with major depression and have not responded well to at least two different antidepressant medications and a course of therapy. Participants will have two treatment sessions spaced four weeks apart, where the focused ultrasound will be directed at targeted brain areas using a special helmet device. They will then have several follow-up visits over the next month after each treatment to check how they are doing and to monitor safety. This study is currently recruiting participants and is open to all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Deemed to have the capacity to provide informed consent.
• • 2. Aged between 18 and 65 years.
• • 3. Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria.
• • 4. Total score \>20 on the Hamilton Depression Rating Scale (HAMD-17).
• • 5. On a stable regimen of psychiatric medications for at least 30 days prior to enrollment.
• • 6. Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, as assessed by two psychiatrists.
• • 7. Documented previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD, sustained for at least 6 weeks.
• Exclusion Criteria:
• • 1. Pregnant or intending to become pregnant during the study period.
• • 2. Diagnosis of a substance use disorder (excluding cannabis or nicotine) of moderate severity or greater, or when the substance is the primary focus of treatment, based on DSM-5 criteria.
• • 3. Known active seizure disorder, significant head injury with an imaging-verified lesion
• • 4. Unstable medical illness.
• • 5. Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
• • 6. Inability to reliably attend required screening, treatment, or follow-up appointments.
• • 7. Severe claustrophobia, as identified by the participant, that would prevent completion of MRI procedures.