Low-Intensity Focused Ultrasound for Treatment-Resistant Depression
Paused · Not applicable · Has a placebo group
Conditions studied: Major Depressive Disorder, Treatment Resistant Depression
In brief
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 advantage of being able to target subcortical transcranial targets, which may have superior efficacy or a shorter treatment course compared to other available treatments such as transcranial magnetic stimulation. This study will investigate the effect of this stimulation on the left subgenual cingulate cortex, a highly connected node in the depression network that is correlated with clinical symptomatology.
Key facts
- Study ID
- NCT06013384
- Run by
- Medical University of South Carolina
- People needed
- 1
- Starts
- 2024-02-16
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- 30 Bee Street — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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