Clinical trial NCT04557891: Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
Official title: Feasibility of Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: focused ultrasound
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Medical University of South Carolina
First posted: 2020-09-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 1 week after the fourth LIFUP treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: University of California, Los Angeles
name: Margaret G Distler, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Taylor P Kuhn, PhD
role: PRINCIPAL_INVESTIGATOR
References: