Using focused ultrasound to treat generalized anxiety disorder

Feasibility of Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)

This study is testing whether a new ultrasound treatment can help people with generalized anxiety disorder who haven't found relief from regular medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 3 sites (Los Angeles, California and 2 other locations)
• Trial ID: NCT04557891 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of low-intensity focused ultrasound pulsation (LIFUP) to treat patients with generalized anxiety disorder (GAD) who have not responded to standard psychopharmacological therapies. In a double-blind, sham-controlled design, 48 participants will receive either active or sham ultrasound treatment targeting the amygdala, a brain structure associated with anxiety. The severity of anxiety will be assessed using standardized psychometric scales before, during, and after the treatment sessions, which will occur over four sessions. The goal is to evaluate the efficacy of this novel approach in alleviating anxiety symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a primary diagnosis of moderate to severe generalized anxiety disorder who have failed at least two SSRIs and one augmentation treatment.

Not a fit: Patients with primary anxiety disorders other than GAD or those currently using non-prescribed psychoactive medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, non-invasive option for patients suffering from generalized anxiety disorder who have not benefited from traditional therapies.

How similar studies have performed: While focused ultrasound is a relatively novel approach in treating neuropsychiatric conditions, preliminary studies suggest potential efficacy, but this specific application for GAD is largely untested.

Eligibility criteria

Inclusion Criteria:

1. Male or female
2. Age 18-65
3. Normal or corrected-to normal vision and hearing
4. Primary diagnosis of generalized anxiety disorder, moderate/severe per DSM-5. (HAM-A\>17) 4a) The duration of the illness must exceed one year.
5. Must be medically stable as determined by investigator
6. Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation
7. History of rTMS is permitted, but not required.

Exclusion Criteria:

1. Diagnosis of primary DSM-5 anxiety disorder other than GAD 1a) Affective disorders such as unipolar or bipolar depression are permitted as long as GAD is primary
2. Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of GAD)
3. Contraindication to enter the MRI environment
4. Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short-term)
5. Inability to adhere to treatment schedule
6. Initiation of new anxiolytic treatment at the time of study randomization

Where this trial is running

Los Angeles, California and 2 other locations

• University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Margaret G Distler, MD,PhD — University of California, Los Angeles
• Study coordinator: Margaret G Distler, MD,PhD

Conditions Generalized Anxiety Disorder; focused ultrasound