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NCT03449979: SSDE

Single Session of tACS in a Depressive Episode

Completed NA Results posted Last updated 4 June 2020
What this trial tests

NA trial testing XCSITE100 Stimulator Sham in Depression in 84 participants. Completed in 16 August 2019.

Timeline
19 September 2018
Primary endpoint
16 August 2019
16 August 2019

Quick facts

Lead sponsorUniversity of North Carolina, Chapel Hill
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposebasic science
Enrollment84
Start date19 September 2018
Primary completion16 August 2019
Estimated completion16 August 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 65, any sex, with Depression or Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Alpha Frequency Electrical Activity in Left Frontal Cortex From Stimulation Primary · 5 minute recording before and after intervention

Fast Fourier transform is applied to 5 minutes of EEG data before and after intervention. Primary outcome is the difference in alpha frequency amplitude (8-12 Hz) in the left frontal cortex from baseline as a result of intervention.

GroupValue95% CI
Alpha Stimulation in Participants in a Depressive Episode-0.005± 0.022
Sham Stimulation in Participants in a Depressive Episode0.008± 0.023
Alpha Stimulation in Healthy Participants0.004± 0.017
Sham Stimulation in Healthy Participants0.007± 0.022

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected over the 5 hours of the single session experiment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Alpha Stimulation in Patients in a Depressive Episode
Serious: 0/21 (0%)
Deaths: 0/21
Sham Stimulation in Patients in a Depressive Episode
Serious: 0/20 (0%)
Deaths: 0/20
Alpha Stimulation in Healthy Participants
Serious: 0/21 (0%)
Deaths: 0/21
Sham Stimulation in Healthy Participants
Serious: 0/22 (0%)
Deaths: 0/22
Other adverse events (7 terms — click to expand)

ReactionSystemAlpha Stimulation in Patie…Sham Stimulation in Patien…Alpha Stimulation in Healt…Sham Stimulation in Health…
TinglingInvestigations
Burning sensationInvestigations
Flickering LightsInvestigations
ItchingInvestigations
Scalp painInvestigations
Neck painInvestigations
HeadacheInvestigations

Data from ClinicalTrials.gov NCT03449979 adverse events section.

Sponsor's own description

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, ages 18-65, with depressed mood; 40 healthy males and females, ages 18-65, free of neurological or psychiatric conditions. Procedures: This is a single visit study with two stimulation conditions (tACS and sham tACS). The session will begin with clinical assessments (including confirmation of diagnosis), followed by an interactive EEG task, then a 7 minute resting state EEG (2 minutes eyes closed, 5 minutes eyes open), followed by the stimulation session (40 minutes of tACS or sham tACS), followed by an additional 5 minute resting state EEG. The stimulation will involved 40 minutes of transcranial alternating current stimulation, 2 mA in amplitude and at individualized alpha frequency (determined by the 2 minutes eyes closed EEG recording; between 8 and 12Hz).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Reduction in Left Frontal Alpha Oscillations by Transcranial Alternating Current Stimulation in Major Depressive Disorder Is Context Dependent in a Randomized Clinical Trial.
    Riddle J, Alexander ML, Schiller CE, Rubinow DR, et al · · 2022 · cited 39× · PMID 34273556 · DOI 10.1016/j.bpsc.2021.07.001
  2. ACNP 61<sup>st</sup> Annual Meeting: Poster Abstracts P1 - P270.
    · 2022 · PMID 36456693 · DOI 10.1038/s41386-022-01484-1
  3. Reduction in left frontal alpha oscillations by transcranial alternating current stimulation in major depressive disorder is context-dependent in a randomized-clinical trial
    Riddle J, Alexander ML, Schiller CE, Rubinow DR, et al · · 2021 · DOI 10.1101/2021.06.17.21258764

Verify or expand the search:

Other trials of XCSITE100 Stimulator Sham

Trials testing the same drug.

Other recruiting trials for Depression

Currently open trials in the same condition.

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03449979.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing