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Clinical Trials/NCT02793258
NCT02793258
Completed
Not Applicable

Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression

Hôpital le Vinatier1 site in 1 country60 target enrollmentJuly 22, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Hôpital le Vinatier
Enrollment
60
Locations
1
Primary Endpoint
Number of correct responses at a facial expression recognition task
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Background: transcranial direct current stimulation (tDCS) is an innovative treatment for major depression. However, its mechanisms of action are still unclear. Major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. In this randomized double-blind study, the investigators aim to assess the effect of tDCS on emotional processing in major depression.

Detailed Description

Methods: 40 subjects with major depression (20 active treatment and 20 placebo) will receive ten 30-minutes sessions of active two milliamps or sham tDCS (anode over left dorsolateral prefrontal cortex and cathode over right dorsolateral prefrontal cortex), twice a day for 5 consecutive days. Psychometric assessment of depression (MADRS,Beck Depression Inventory , CGI) and a neuropsychological assessment will be conducted before and after the treatment. A facial emotion recognition task and an attentional emotional task with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session. The investigators hypothesize that active tDCS will improve emotional processing in major depression, and that this will be observed after 1 and 10 sessions of tDCS. Conclusions: Studying the impact of transcranial direct current stimulation on emotional processing in major depression could allow to better understand its antidepressant mechanisms

Registry
clinicaltrials.gov
Start Date
July 22, 2016
End Date
December 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hôpital le Vinatier
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy controls:
  • Age between 18 and 65 years
  • Given consent.
  • Depressed subjects:
  • Major depressive episode (no psychotic features) according to Diagnostic ans Statistical of Mental Disorders number 5 (DSM 5.0.)
  • Age from 18-65
  • Antidepressant stable for the last 4 weeks
  • Given consent

Exclusion Criteria

  • Healthy controls:
  • Psychiatric disorder
  • Addiction except for tobacco addiction
  • Ocular disease (except from refraction disorders), neurologic or cardiac disease.
  • Neuroleptic or anticonvulsivant treatment
  • Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
  • Depressed subjects:
  • Other psychiatric disorder except for personality disorders
  • Ocular disease (except from refraction disorders), neurologic or cardiac disease.
  • Neuroleptic or anticonvulsivant treatment

Outcomes

Primary Outcomes

Number of correct responses at a facial expression recognition task

Time Frame: within 5 days after stimulation

A computerized facial expression recognition task was designed for the study. 240 pictures of emotional faces (8 identities, expressing anger, sadness, happiness, surprise, disgust, or fear, morphed with intensity of 20, 40, 50, 60 and 80%) are randomly displayed on a screen for 500ms. Subjects are asked to identify the emotion by answering on a keyboard. Rate of correct responses is the main outcome. During this task, eye movements are recorded by an eye-tracking device. Skin conductance, respiratory and heart rate frequency are also recorded

Secondary Outcomes

  • Evolution of the depressive symptoms measured by MADRS(an average of two weeks)
  • Skin conductance measured in speed per microseconds(within 5 days after stimulation)
  • Heart rate measured in number of heart pulses per milliseconds(within 5 days after stimulation)
  • Respiratory frequency measured in number of respiratory cycles per minute(within 5 days after stimulation)
  • Beck depression inventory scale(within 5 days after stimulation)
  • Eye movements during facial emotion recognition task and attentional task(within 5 days after stimulation)
  • Performance on an attentional dot-probe task(within 5 days after stimulation)
  • tests of executive functions(an average of two weeks)
  • Clinical global impression scale(an average of two weeks)

Study Sites (1)

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