Generalized Anxiety Disorder Clinical Trial
Official title:
Feasibility of Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Massachusetts General Hospital, Medical University of South Carolina |
United States,
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 |
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 |
NCT02256566 -
Cognitive Training for Mood and Anxiety Disorders
|
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 |
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 |
NCT01201967 -
A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients
|
Phase 4 | |
Completed |
NCT01342120 -
PHARMO Institute Seroquel Safety Study
|
N/A | |
Completed |
NCT01337713 -
Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
|
N/A | |
Completed |
NCT01971203 -
Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat
|
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 |
NCT00744627 -
Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.
|
Phase 3 | |
Terminated |
NCT01244711 -
Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines
|
Phase 4 | |
Completed |
NCT00711737 -
Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
|
N/A | |
Completed |
NCT00525226 -
Evaluating the Effects of Stress in Pregnancy
|
N/A | |
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 |
NCT00515242 -
Therapeutic Massage for Generalized Anxiety Disorder
|
Phase 1/Phase 2 | |
Completed |
NCT00620776 -
Combined Treatment for Generalized Anxiety Disorder (GAD)
|
Phase 2 |