Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

A total of 20 participants with treatment-resistant depression will be enrolled and treated in this study. Participants will be recruited through local psychiatric practices, referrals from participating institutions, and external referrals, including both physician and self-referrals.

Eligibility will be assessed during a dedicated screening appointment conducted by the study coordinator in collaboration with a study-affiliated physician. The anticipated enrollment period is approximately two years, beginning from the date of first patient enrollment to the enrollment of the final participant.

Inclusion criteria

• Deemed to have the capacity to provide informed consent.
• Aged between 18 and 65 years.
• Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria.
• Total score >20 on the Hamilton Depression Rating Scale (HAMD-17).
• On a stable regimen of psychiatric medications for at least 30 days prior to enrollment.
• Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, as assessed by two psychiatrists.
• Documented previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD, sustained for at least 6 weeks.

Exclusion criteria

• Pregnant or intending to become pregnant during the study period.
• 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.
• Known active seizure disorder, significant head injury with an imaging-verified lesion
• Unstable medical illness.
• Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
• Inability to reliably attend required screening, treatment, or follow-up appointments.
• Severe claustrophobia, as identified by the participant, that would prevent completion of MRI procedures.