fMRI Study of tES in Major Depression (NCT04031547) | Clinical Trial Compass
CompletedEarly Phase 1
fMRI Study of tES in Major Depression
United States11 participantsStarted 2019-02-01
Plain-language summary
This is a functional MRI study that will examine the effects of noninvasive transcranial electrical stimulation (tES) on brain function in individuals with Major Depression.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* ages between 18 and 55
* diagnosis of Major Depressive Disorder made by a physician, psychiatrist, or psychologist at least one year prior
* mild-to-moderate symptoms of depression (Hamilton Depression Rating Scale 17-item, HDRS-17, score 8-23)
* stable standard or no pharmacological antidepressant regimen (SSRI, SNRI, MAOI, or trycyclic/TCA) with no change in treatment 6 weeks prior to study start
Exclusion Criteria:
* suicidal thoughts, ideation, or behavior within the past month (HDRS-17 item 3 score greater than 1)
* greater than moderate symptoms of depression within the past month (HDRS-17 score \>23)
* change in antidepressant medication within 6 weeks of study start
* diagnosis of any medical condition potentially affecting brain function, including neuropsychiatric or mental disorders, other mood disorders (bipolar disorder, anxiety, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence
* MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy
* tES contraindications: skin conditions or injuries on the scalp, hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers
* other major medical conditions (e.g., cancer, stroke)
* current medication use potentially affecting brain functi…
What they're measuring
1
Changes in brain function measured with blood-oxygenation-level-dependent (BOLD) functional MRI
Timeframe: 5 minutes before, 5 minutes during, and 5 minutes after tES