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New treatment option for Major Depressive Episode
Official title Personalized Ultrasonic Brain Stimulation for Depression (R61)
ClinicalTrials.gov ID: NCT06902298
What this study is testing
- What it's testing
- 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 range of stimulation parameters during psychological and physiological monitoring.
- Phase 2: a mid-size study of how well it works
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
- 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...
You likely can't join if
- 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).
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, 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 Salt Lake City, Utah, 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.