BridgeMD
New treatment option for Generalized Anxiety Disorder
Official title Low-Intensity Focused Ultrasound Pulsation (LIFUP) for the Treatment of Generalized Anxiety Disorder (GAD)
ClinicalTrials.gov ID: NCT04557891
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female
- Age 18-65
- Normal or corrected-to normal vision and hearing
- Primary diagnosis of generalized anxiety disorder, moderate/severe per DSM-5. (HAM-A\>17) 4a) The duration of the illness must exceed one year.
- Must be medically stable as determined by investigator
You likely can't join if
- Diagnosis of primary DSM-5 anxiety disorder other than GAD 1a) Affective disorders such as unipolar or bipolar depression are permitted as long as...
- Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of GAD)
- Contraindication to enter the MRI environment
- Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short-term)
- Inability to adhere to treatment schedule
- Initiation of new anxiolytic treatment at the time of study randomization
See the full eligibility criteria
- Male or female
- Age 18-65
- Normal or corrected-to normal vision and hearing
- Primary diagnosis of generalized anxiety disorder, moderate/severe per DSM-5. (HAM-A\>17) 4a) The duration of the illness must exceed one year.
- Must be medically stable as determined by investigator
- Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation
- History of rTMS is permitted, but not required.
- 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
- Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of GAD)
- Contraindication to enter the MRI environment
- Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short-term)
- Inability to adhere to treatment schedule
- Initiation of new anxiolytic treatment at the time of study randomization
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Boston, Massachusetts, United States
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Boston, Massachusetts, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.