Status:
SUSPENDED
Low-Intensity Focused Ultrasound for Treatment-Resistant Depression
Lead Sponsor:
Medical University of South Carolina
Conditions:
Major Depressive Disorder
Treatment Resistant Depression
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The Investigators are proposing to demonstrate safety and efficacy of LIFUP for treatment resistant major depressive disorder in a ten-patient pilot study. LIFUP is an emerging treatment with the adva...
Detailed Description
The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low intensity focused ultrasound pulsation (LIFUP) for treatment resistant depression (TRD). Participants will ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female
- Age 18-70
- Normal or corrected-to normal vision and hearing
- Primary diagnosis of major depressive disorder, moderate/severe per DSM-5 (MADRS \>20)
- 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
- Exclusionary criteria:
- Diagnosis of primary DSM-5 depressive disorder other than MDD
- Anxiety disorders such as GAD are permitted as long as MDD is primary
- Diagnosis of schizophrenia or bipolar disorder
- Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of MDD)
- Contraindication to enter the MRI environment.
- Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
- Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study includes: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.
- Inability to adhere to treatment schedule.
- Initiation of new antidepressant treatment at the time of study randomization.
Exclusion
Key Trial Info
Start Date :
February 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT06013384
Start Date
February 16 2024
End Date
June 1 2026
Last Update
April 24 2025
Active Locations (1)
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1
30 Bee Street
Charleston, South Carolina, United States, 29403