Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Henri Laborit

About this trial

The main objective of this study is to demonstrate that 15 transcranial direct current stimulation (tDCS) sessions of 30 minutes at 2 mA intensity are effective to reduce suicidal ideation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age over 18 years

Written informed consent

Diagnosis of recurrent or isolated depressive episode according to DSM IV criteria (A.P.A. 1994).

Stable antidepressant treatment for 3 weeks

Disqualifiers

Depression with psychotic features Axis I (DSM IV) co-morbid diagnosis of schizophrenia, alcohol and/or other substance dependence (or abuse) (lifetime)

Patient who has already undergone an electroconvulsive therapy course for the current episode and does not respond to this treatment

Patient deprived of liberty

Patient with high suicide risk (item 10 MADRS > 4) in the absence of hospitalization

Trial design

Design model

Single group

Treatments tested in this trial

  • Transcranial direct current stimulation

    Device

    1 stimulation per day during 15 days.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Active tDCSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in suicidal ideation on the Scale for Suicide Ideation (SSI) at "Day 19"

The main judgment criterion is the evolution of suicidal ideation which is evaluated by the Beck Scale for Suicide Ideation (SSI) between Baseline and "Day 19"

Time frame
Baseline and "Day 19"

Secondary outcomes

1

Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 19" post-tDCS sessions

The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).

Time frame
Baseline and "Day 19"
2

Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 49" post-tDCS sessions

The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).

Time frame
Baseline and "Day 49"
3

Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 79" post-tDCS sessions

The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).

Time frame
Baseline and "Day 79"
4

Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 19" post-tDCS sessions

The Implicit Association Test (IAT) is a computer-based test measuring implicit mental associations between two concepts. The IAT uses reaction times to categorize stimuli that appear in the middle of the screen into two target categories, in our study: "Death" (suicide, dies, funeral, lifeless, deceased) and "Life". (survive, grow, breathe, alive, live) and/or in two attribute categories "Me" (me, myself, my, mine, I) and "Not Me" (them, they, their, his, others) . and subjects rapidly classify them by pressing one of two keys (the category of right (by pressing the I key) or left (by pressing the E key). According to the logic of the IAT, "D positive" scores represent a strong implicit association between "Me" and "Death". We will use Greenwald's improved algorithm to analyze responses.

Time frame
Baseline and "Day 19"

Other outcomes

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