No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
University of California, Los Angeles · Other
Who this trial is looking for
This trial is looking for adults with generalized anxiety disorder who have not found relief from standard treatments. Participants will receive focused ultrasound treatment for their anxiety over four sessions.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old
I have been diagnosed with generalized anxiety disorder for over a year
I have tried and failed treatment with at least 2 SSRI medications
I am medically stable
I have normal or corrected vision and hearing
You may not be able to join if
I have another primary anxiety disorder
I use non-prescribed psychoactive medications
I am pregnant or plan to become pregnant soon
I cannot follow the treatment schedule
I have a contraindication to enter an MRI environment
I am starting new anxiety treatment right now
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
There are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. Existing brain stimulation methods such as rTMS fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. In this double-blind sham-controlled clinical trial, the investigators propose to establish basel…
There are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. Existing brain stimulation methods such as rTMS fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. In this double-blind sham-controlled clinical trial, the investigators propose to establish baseline severity of anxiety in 48 patients, then deliver eight treatments over four sessions of focused ultrasound stimulation to the amygdala. Anxiety severity will be assessed using standard psychometric scales after each session, and at follow-ups.
Trial Locations
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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 inve…
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
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