Depression Clinical Trial
Official title:
Functional MRI Study of Transcranial Electrical Stimulation in Major Depression
Verified date | February 2023 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics, or antidepressants - prisoners will not participate in this study |
Country | Name | City | State |
---|---|---|---|
United States | Center for Translational Imaging at Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Brain & Behavior Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in brain function measured with blood-oxygenation-level-dependent (BOLD) functional MRI | Blood-oxygenation-level-dependent functional MRI will be used to measure changes in the temporal coherence (functional connectivity) amongst brain regions before, during, and after tES. | 5 minutes before, 5 minutes during, and 5 minutes after tES |
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