Status:
RECRUITING
Personalized Ultrasonic Brain Stimulation for Depression (R61)
Lead Sponsor:
Brian Mickey
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Episode
Depression - Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will be delivered using a ...
Detailed Description
This R61 project has 3 aims: 1. To determine whether stimulation engages the subcallosal cingulate (SCC) in an intensity-dependent manner 2. To examine the degree of specificity of neuromodulation by...
Eligibility Criteria
Inclusion
- Age 18-65, any gender.
- Primary diagnosis of DMS-5 major depressive disorder (MINI).
- Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months (MINI).
- Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score \> 10.
- History of at least 2 failed trials of evidence-based antidepressant medication and/or psychotherapy (at least one trial during the current depressive episode).
- Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study.
- For participants of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study.
- Capacity to provide informed consent; provision of a signed and dated consent form
- Currently are under the care of a licensed psychiatrist or other mental health care provider, or a licensed addiction medicine specialist and agrees to promptly inform the investigator or the study staff of any change in these providers.
- Agrees to allow any and all forms of communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event.
- Agrees to provide the name and verifiable contact information (email and mailing addresses, mobile and land-line phone numbers, as applicable) of at least two persons 22 years or older who reside within a 60-minute drive of the patient's residence. Subject agrees that in the event of a safety concern or event during study participation, research staff is at liberty to contact these individuals if the subject does not respond to contact attempts.
Exclusion
- History of serious brain injury or other neurologic disorder.
- Poorly managed general medical condition.
- Pregnant or breast feeding.
- Implanted device in the head or neck.
- MRI intolerance or contraindication.
- Brain stimulation treatment such as ECT, TMS, or VNS (past month).
- Recent change in antidepressant treatments (past month).
- 8\. Moderate-High Risk of Suicide according to the Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (answers YES to Question 3 and NO to Question 6 (Moderate risk) or YES to Question 4, 5, or 6 (High risk)) and/or in the clinical judgement of the PI or a study psychiatrist
- Suicidal behavior (past year).
- Serious suicide attempt 33 (lifetime).
- Moderate-to-severe substance use disorder (MINI, past 3 months).
- Obsessive compulsive disorder, primary diagnosis (MINI, past month).
- Posttraumatic stress disorder, primary diagnosis (MINI, past month).
- Bipolar-spectrum disorder (MINI, lifetime).
- Schizophrenia-spectrum disorder (MINI, lifetime).
- Neurocognitive disorder (DSM-5, past year).
- Severe personality disorder.
- Clinically inappropriate for participation in the study as determined by the study team.
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06902298
Start Date
March 10 2025
End Date
November 1 2026
Last Update
January 9 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Utah
Salt Lake City, Utah, United States, 84108