Clinical trial NCT02793258: Impact of tDCS on Emotional Processing in Major Depression
Official title: Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: tDCS
neuromodulation
depression
cognition
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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
* 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)

Primary outcomes:
measure: Number of correct responses at a facial expression recognition task
timeFrame: within 5 days after stimulation
Secondary outcomes:
measure: Evolution of the depressive symptoms measured by MADRS
timeFrame: an average of two weeks
measure: Performance on an attentional dot-probe task
timeFrame: within 5 days after stimulation
measure: tests of executive functions
timeFrame: an average of two weeks
measure: Beck depression inventory scale
timeFrame: within 5 days after stimulation
measure: Clinical global impression scale
timeFrame: an average of two weeks
measure: Eye movements during facial emotion recognition task and attentional task
timeFrame: within 5 days after stimulation
measure: Skin conductance measured in speed per microseconds
timeFrame: within 5 days after stimulation
measure: Heart rate measured in number of heart pulses per milliseconds
timeFrame: within 5 days after stimulation
measure: Respiratory frequency measured in number of respiratory cycles per minute
timeFrame: within 5 days after stimulation
Other outcomes:
Locations:
city: Lyon
country: France
facility: Ch Le Vinatier
state: Rhone Alpes
Study officials:
affiliation: Centre Hospitalier le Vinatier
name: HAESEBAERT FREDERIC, PH
role: PRINCIPAL_INVESTIGATOR
References: