N/A
N=32
Transcranial Alternating Current Stimulation for Major Depressive Disorder
Major Depressive Disorder · MDD
Bottom Line
View on ClinicalTrials.gov: NCT02339285 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score — -13.60; -8.82; -8.27 units on a scale — p=>0.10
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tACS (alpha) (Device); tACS (gamma) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score |
-13.60; -8.82; -8.27 | >0.10 |
| SECONDARY Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation |
-1.75; 0.53; 0.24; -1.23; 0.12; -0.02 | <0.05 sig |
| SECONDARY Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention |
-0.42; 0.09; 0.55; -0.57; 0.00; 0.41 | >0.10 |
Summary
Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on patients with Major Depressive Disorder (MDD).
Eligibility Criteria
Inclusion Criteria
- Male or female, 18-65 years old
- Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) diagnosis of MDD; unipolar, non-psychotic
- Hamilton Depression Rating Scale score >8
- Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- Meet criteria for low suicide risk
- Willing to comply with all study procedures and be available to do so for the duration of the study
- Women of reproductive potential must use highly effective contraception
Exclusion Criteria
- DSM-IV diagnosis of alcohol of substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
- Current use of benzodiazepines or anti-epileptic drugs
- Current axis I mood, or psychotic disorder other than major depressive disorder
- Lifetime comorbid psychiatric bipolar or psychotic disorder
- Eating disorder (current or within the past 6 months)
- Obsessive-compulsive disorder (lifetime)
- Post traumatic stress disorder (PTSD; current or within the last 6 months)
- Attention Deficit Hyperactivity Disorder (ADHD; currently under treatment)
- 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 ECT induced seizures), dementia, history of stroke, Parkinson's disease, multiple sclerosis, cerebral aneurism
- 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
- Prior brain surgery
- Any brain devices/implants, including cochlear implants and aneurysm clips
- Co-morbid neurological condition (i.e. seizure disorder, brain tumor)
- Non English speakers
- Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation
Data sourced from ClinicalTrials.gov (NCT02339285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.