Low-Intensity Focused Ultrasound for Treatment-Resistant Depression

Inclusion Criteria

• •Male or female
• •Age 18-70
• •Normal or corrected-to normal vision and hearing
• •Primary diagnosis of major depressive disorder, moderate/severe per DSM-5 (MADRS \>20)
• •The duration of the illness must exceed one year
• •Must be medically stable as determined by investigator
• •Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation
• •History of rTMS is permitted, but not required
• •Exclusionary criteria:
• •Diagnosis of primary DSM-5 depressive disorder other than MDD
• •Anxiety disorders such as GAD are permitted as long as MDD is primary
• •Diagnosis of schizophrenia or bipolar disorder
• •Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of MDD)
• •Contraindication to enter the MRI environment.
• •Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
• •Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study includes: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
• •Inability to adhere to treatment schedule.
• •Initiation of new antidepressant treatment at the time of study randomization.