Status:
COMPLETED
Single Session of tACS in a Depressive Episode
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Purpose: Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on healthy participants and participants with mood disorders. Participants: 40 males and females...
Detailed Description
Participants will report for a study visit and will review and sign a consent form. Participants will complete several clinical assessments and also take a urine drug test and urine pregnancy test (i...
Eligibility Criteria
Inclusion
- Inclusion Criteria for individuals with depressed mood:
- Ages 18-65 years
- Hamilton Depression Rating Scale score \>8
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Low suicide risk which will be determined through the use of both the Structured Clinical Interview for the DSM-5 and by scoring less than 3 (0,1, or 2) in the Hamilton rating depression scale.
- Negative pregnancy test for female participants
- Exclusion Criteria for individuals with depressed mood:
- DSM-5 diagnosis of alcohol of substance abuse (other than nicotine) within the 12 months
- DSM-5 diagnosis of alcohol or substance dependence (other than nicotine) within the last 12 months
- DSM-5 diagnosis of personality disorder
- Eating disorder (current or within the past 3 months)
- Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
- Neurological disorders, including but not limited to history of seizures (except childhood febrile seizures and electro-convulsive therapy (ECT) induced seizures), dementia, history of stroke, Parkinson's disease, multiple sclerosis, cerebral aneurysm.
- Medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation
- History of traumatic brain injury, reoccurring seizures or later cognitive rehabilitation or causing cognitive sequelae
- History of childhood trauma (determined by the Childhood Trauma Questionnaire)
- Prior brain surgery
- Any brain devices/implants, including cochlear implants and aneurysm clips
- Co-morbid neurological condition (i.e. seizure disorder, brain tumor)
- Use of illicit drugs, confirmed by a drug test
- Non English speakers
- Pregnant or nursing females
- Current use of benzodiazepines or anti-epileptic drugs
- Inclusion Criteria for healthy controls:
- Ages 18-65 years
- Hamilton Depression Rating Scale score ≤8
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Negative pregnancy test for female participants
- Exclusion Criteria for healthy controls:
- History of major neurological or psychiatric illness, including epilepsy
- Medication use associated with neurological or psychiatric illnesses
- Currently undergoing counseling or psychotherapy treatment for depression, anxiety, eating disorders, PTSD or other behavioral conditions
- DSM-5 diagnosis of personality disorder
- First degree relative (parent, sibling, child) with major neurological or psychiatric illness
- Prior brain surgery
- Major head injury
- Any brain devices/implants (including cochlear implants and aneurysm clips)
- History of childhood trauma (determined by the Childhood Trauma Questionnaire)
- Use of illicit drugs, confirmed by a drug test
- Braids or other hair styling that prevents direct access to the scalp (if removal not possible)
- Skin allergies or very sensitive skin
- Non English speakers
- Pregnant or nursing females
Exclusion
Key Trial Info
Start Date :
September 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03449979
Start Date
September 19 2018
End Date
August 16 2019
Last Update
June 4 2020
Active Locations (1)
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1
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599