NCT04557891 Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
| NCT ID | NCT04557891 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Generalized Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2021-07-26 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2021-07-26 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Margaret G Distler, MD,PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT04557891 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Generalized Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04557891 currently recruiting?
Yes, NCT04557891 is actively recruiting participants. Contact the research team at mdistler@mednet.ucla.edu for enrollment information.
Where is the NCT04557891 trial being conducted?
This trial is being conducted at Los Angeles, United States, Boston, United States, Charleston, United States.
Who is sponsoring the NCT04557891 clinical trial?
NCT04557891 is sponsored by University of California, Los Angeles. The principal investigator is Margaret G Distler, MD,PhD at University of California, Los Angeles. The trial plans to enroll 48 participants.
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