Status:
COMPLETED
fMRI Study of tES in Major Depression
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Brain & Behavior Research Foundation
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief 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.
Detailed Description
The purpose of this research study is to understand how a kind of brain stimulation, called transcranial electrical stimulation (tES), affects brain function in people with major depression. tES deli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04031547
Start Date
February 1 2019
End Date
November 30 2022
Last Update
February 9 2023
Active Locations (1)
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1
Center for Translational Imaging at Northwestern University
Chicago, Illinois, United States, 60611