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RecruitingNCT06009523tDCS-IDSDEPUpdated Jun 5, 2025

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

An interventional study of Transcranial direct current stimulation in Depression and Suicide, sponsored by Centre Hospitalier Henri Laborit. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Centre Hospitalier Henri Laborit · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening visit to determine eligibility for study entry. Patient who meet the eligibility requirements be able to start the 15 tDCS sessions at the rate of one session per day. After the last session, patients will perform three follow-up visits on D19, D49 and D79

02

Conditions studied

  • Depression and Suicide

Keywords

  • tDCS
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's planned enrollment of 50 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Centre Hospitalier Henri Laborit is the lead sponsor of 27 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • MADRS score ≥ 20
  • SSI score > 3
  • Subject affiliated to a health insurance system
  • Woman with effective contraception and agreeing to maintain it throughout the study period.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Contraindication to tDCS: intracerebral metallic implant (with the exception of dental implants), cardiac pacemaker, active or non-implanted devices in the region of the head, acute eczema in the planned stimulation area
  • Pregnant, parturient or breastfeeding woman
  • Simultaneous participation in another interventional research
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Active tDCS

    Participants received an active tdcs: transcranial direct current with an intensity of 2 mA for 30 minutes

    Device: Transcranial direct current stimulation

Interventions

  • DeviceTranscranial direct current stimulation

    1 stimulation per day during 15 days.

06

What researchers measure

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"

  5. Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 49" 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 49"

  6. Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 79" 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 79"

  7. Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 19" post-tDCS sessions

    The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.

    Time frame: Baseline and "Day 19"

  8. Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 49" post-tDCS sessions

    The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.

    Time frame: Baseline and "Day 49"

  9. Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 79" post-tDCS sessions

    The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.

    Time frame: Baseline and "Day 79"

07

Study locations

2 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06009523
Lead sponsor
Centre Hospitalier Henri Laborit
Responsible party
Sponsor
First posted
Aug 24, 2023
Start date
Oct 26, 2023
Primary completion
Sep 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jun 5, 2025

Study contacts

Ghina Harika-Germaneau
Contact
ghina.harika-germaneau@ch-poitiers.fr
05.16.52.61.18

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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