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.