Impact of tDCS on Emotional Processing in Major Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT02793258
• Lead Sponsor: Hôpital le Vinatier

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

Study Timeline

• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-08
• Study Start: 2016-07-22
• Primary Completion: 2021-05-17
• Study Completion: 2021-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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
• MADRS ≥ 20.
• 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
• Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of correct responses at a facial expression recognition task	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 Outcome Measures

Name	Time	Method
Evolution of the depressive symptoms measured by MADRS	an average of two weeks	Montgomery-Asberg Depression Rating Scale is a 10-item scale to evaluate the intensity of the depressive symptoms.
Skin conductance measured in speed per microseconds	within 5 days after stimulation	Recorded with physiologic data system (BIOPAC)
Beck depression inventory scale	within 5 days after stimulation
Eye movements during facial emotion recognition task and attentional task	within 5 days after stimulation	Recorded by Eye tracker.Measurement of total time spent on specific Region of interest (eyes, nose, mouth, emotional face)
Performance on an attentional dot-probe task	within 5 days after stimulation	Computerized "dot-probe " attentional task designed for the study. Pairs of emotional faces (neutral/sad ou neutral/happy) are randomly presented on a screen for 1000ms. Then, a probe is presented during 1100ms.subjects are asked to indicate a which side the probe approved During this task, eye movements are recorded by an eye-tracking device. Total time spent on Region of Interest (sad, happy or neutral face) is measured.; Skin conductance, respiratory and heart rate frequency are also recorded.
tests of executive functions	an average of two weeks	Neuropsychological assessment : attentional functioning (TAP), executive functioning (BADS, working memory, go/no-go, stroop), memory (california verbal learning test) Improvement of executive functioning by tDCS will be assessed.
Clinical global impression scale	an average of two weeks
Heart rate measured in number of heart pulses per milliseconds	within 5 days after stimulation	Recorded with physiologic data system (BIOPAC)
Respiratory frequency measured in number of respiratory cycles per minute	within 5 days after stimulation	Recorded with physiologic data system(BIOPAC)

Trial Locations

Locations (1)

Ch Le Vinatier; 🇫🇷 Lyon, Rhone Alpes, France