Status:
ACTIVE_NOT_RECRUITING
Personalized Ultrasonic Brain Stimulation for Depression
Lead Sponsor:
University of Utah
Conditions:
Major Depressive Episode
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 first be delivered us...
Eligibility Criteria
Inclusion
- Age 18-65, any gender
- Primary diagnosis of major depressive disorder or bipolar disorder
- Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months
- Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score \> 10
- Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study
- For females 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
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 (e.g., ECT, TMS, VNS) in the past month
- Suicidal ideation (Columbia Suicide Severity Rating Scale screen item #2, past month)
- Lifetime history of a serious suicide attempt
- Moderate-to-severe substance use disorder (past 3 months)
- Obsessive compulsive disorder (past month)
- Posttraumatic stress disorder (past month)
- Schizophrenia-spectrum disorder (lifetime)
- Neurocognitive disorder (past year)
- Personality disorder as a current focus of treatment
- Clinically inappropriate for participation in the study as determined by the study team
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05301036
Start Date
July 15 2022
End Date
December 14 2024
Last Update
August 9 2024
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84108