Focused ultrasound neuromodulation for treatment-resistant 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, non-randomized pilot enrolling 20 adults with treatment-resistant major depressive disorder. Participants will receive two MRI-guided focused ultrasound neuromodulation sessions targeting nodes of the cortical-striatal-thalamic circuit, spaced four weeks apart, using the Next Generation Dome Helmet (NGDH). Safety and initial clinical effects will be monitored with clinical rating scales and imaging at 24 hours, 2 weeks, and 4 weeks after each treatment session. Eligibility requires DSM-5 MDD, HAMD-17 >20, stable medications, prior trials of at least two antidepressants and prior psychotherapy; treatments and follow-up occur at Sunnybrook Health Sciences Centre in Toronto.

Why it matters

Who can join: the full rules

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.

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

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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.