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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04557891
Other study ID # CTP-LIFUP-GAD-V1.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 26, 2021
Est. completion date December 2025

Study information

Verified date August 2023
Source University of California, Los Angeles
Contact Margaret G Distler, MD,PhD
Phone (310) 794-1553
Email mdistler@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Anxiety disorders have tremendous disease burden in the United States. Up to 1 in 3 Americans will be diagnosed with an anxiety disorder in their lifetimes. Anxiety treatment is typically consisting of psychotherapy (e.g. cognitive behavioral therapy) and medication management (e.g. benzodiazepines, selective serotonin reuptake inhibitors, etc). With major depressive disorder, rTMS is a suitable alternative treatment for refractory depression, rTMS is not approved for treatment of anxiety, nor can rTMS stimulate deep enough to reach those brain circuits involved in anxiety (e.g. the amygdala). Focused ultrasound is a new treatment modality being developed for several different neuropsychiatric conditions. In this study, the investigators propose to randomize 48 individuals to either active or sham treatment. Each participant will be evaluated to establish a baseline diagnose of generalized anxiety disorder, and then will be reassessed after each treatment session (of which there are four). One week and one month after the last treatment session, the investigators will conduct follow-up evaluations.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Active LIFUP Treatment
8 LIFUP Treatments
Sham LIFUP Treatment
8 sham LIFUP treatments

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States University of California, Los Angeles Los Angeles California

Sponsors (3)

Lead Sponsor Collaborator
University of California, Los Angeles Massachusetts General Hospital, Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Anxiety Rating Scale (HAM-A) HAM-A is a rating scale for measuring the severity of anxiety symptoms. 1 week after the fourth LIFUP treatment
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