Phase
Condition
Depression (Major/severe)
Depression
Treatment
Diadem prototype
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-65, any gender
Primary diagnosis of major depressive disorder or bipolar disorder
Current moderate-to-severe depressive episode, without psychotic features, lastingat 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 topsychiatric treatments (medications, psychotherapy) for the duration of the study
For females of reproductive potential: negative pregnancy test or use of highlyeffective contraception for at least 1 month prior to baseline; agreement to usesuch a method throughout the study
Capacity to provide informed consent; provision of a signed and dated consent form
Exclusion
Exclusion Criteria:
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, pastmonth)
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 studyteam
Study Design
Connect with a study center
University of Utah
Salt Lake City, Utah 84108
United StatesSite Not Available
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