Using focused ultrasound to treat generalized anxiety disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mdistler@mednet.ucla.edu
• Phone: (310) 794-1553

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.