Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Terminated NCT03420456 - Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Withdrawn NCT02382224 - Worry Exposure for Generalized Anxiety Disorder N/A
Completed NCT02306356 - Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting N/A
Completed NCT02256566 - Cognitive Training for Mood and Anxiety Disorders N/A
Completed NCT01958788 - Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder N/A
Completed NCT01681329 - Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder N/A
Completed NCT01342120 - PHARMO Institute Seroquel Safety Study N/A
Completed NCT01201967 - A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients Phase 4
Completed NCT01337713 - Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD) N/A
Completed NCT00961298 - An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder Phase 4
Completed NCT01203293 - Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector Phase 1
Completed NCT01971203 - Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat N/A
Terminated NCT01244711 - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines Phase 4
Completed NCT00744627 - Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults. Phase 3
Completed NCT00711737 - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months N/A
Completed NCT00515242 - Therapeutic Massage for Generalized Anxiety Disorder Phase 1/Phase 2
Completed NCT00537615 - An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers Phase 1
Completed NCT00525226 - Evaluating the Effects of Stress in Pregnancy N/A
Completed NCT00368745 - Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use. Phase 3