NCT02339285

Brief Summary

Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) on patients with Major Depressive Disorder (MDD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

May 7, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 20, 2018

Completed
Last Updated

August 20, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

January 12, 2015

Results QC Date

June 12, 2018

Last Update Submit

July 17, 2018

Conditions

Major Depressive DisorderMDD

Keywords

tACSMajor Depressive DisorderMDDmood symptomssham

Outcome Measures

Primary Outcomes (1)

  • Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score

    The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline). In these results, negative values will indicate a decrease in depressive symptoms.

    Baseline to F2 (4 weeks after completion of the intervention)

Secondary Outcomes (2)

  • Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation

    Baseline to Day 5 of Stimulation

  • Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention

    Baseline to F2

Other Outcomes (4)

  • Change in Hamilton Depression Rating Scale (HDRS) Score

    Baseline to Day 5 of Stimulation; Baseline to F2

  • Change in Montreal Cognitive Assessment (MoCA) Score

    Baseline to F2

  • Change in Beck Depression Inventory (BDI) Score

    Baseline to Day 5; Baseline to F2

  • +1 more other outcomes

Study Arms (3)

tACS (alpha)

EXPERIMENTAL

10 Hz tACS with a peak-to-peak amplitude of 2 milliamps (mA) for 40 minutes. Uses tACS (alpha) device.

Device: tACS (alpha)

tACS (gamma)

EXPERIMENTAL

40 Hz tACS with a peak-to-peak amplitude of 2 milliamps (mA) for 40 minutes. Uses tACS (gamma) device.

Device: tACS (gamma)

Sham stimulation

SHAM COMPARATOR

Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation. Uses tACS (alpha) device.

Device: tACS (alpha)

Interventions

tACS (alpha)DEVICE
Sham stimulationtACS (alpha)
tACS (gamma)DEVICE
tACS (gamma)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill Medical School Wing C

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Valiengo L, Bensenor IM, Goulart AC, de Oliveira JF, Zanao TA, Boggio PS, Lotufo PA, Fregni F, Brunoni AR. The sertraline versus electrical current therapy for treating depression clinical study (select-TDCS): results of the crossover and follow-up phases. Depress Anxiety. 2013 Jul;30(7):646-53. doi: 10.1002/da.22079. Epub 2013 Apr 26.

    PMID: 23625554BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Results Point of Contact

Title
Dr. Flavio Frohlich
Organization
University of North Carolina at Chapel Hill
flavio_frohlich@med.unc.edu
(919) 966-4584

Study Officials

  • Flavio Frohlich, PhD

    University of North Carolina at Chapel Hill, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 15, 2015

Study Start

May 7, 2015

Primary Completion

June 19, 2017

Study Completion

June 19, 2017

Last Updated

August 20, 2018

Results First Posted

August 20, 2018

Record last verified: 2018-01

Locations

US(1)