Focused Ultrasound Neuromodulation in Patients With Treatment-Resistant Depression

To join this study, you need to be an adult between 18 and 65 years old and have a diagnosis of major depression that hasn't responded to at least two different antidepressant medications and at least six weeks of talking therapy like CBT. It's important that your current medications have been stable for at least a month.

There are also some reasons why you might not be able to join. For example, if you are pregnant or planning to become pregnant, or if you have certain other health conditions like an active seizure disorder or other serious medical illnesses. This study also involves MRI scans, so you couldn't participate if you have something in your body that isn't safe for an MRI, like certain types of pacemakers.

We also need to make sure you can reliably attend all the scheduled appointments for screening, treatment, and follow-up. If you have severe claustrophobia that would make getting an MRI scan difficult, you might not be suitable for this study.

If you join this study, you would first have a screening appointment with a study doctor and coordinator to check if the study is right for you. If you are eligible, you would then have two main treatment sessions with the special helmet. These sessions would be about four weeks apart.

After each treatment session, you would return for follow-up visits. These visits typically happen 24 hours, 2 weeks, and 4 weeks after each treatment. During these follow-up visits, the study team will use questionnaires and sometimes imaging scans to see how you're feeling and to check for any changes or side effects. You would continue to take your usual psychiatric medications as prescribed throughout the study. The total time you'd be involved in the study would be over several weeks or months, depending on when your treatments are scheduled and your follow-up visits are completed.