NCT06009523

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Oct 2023Dec 2027

First Submitted

Initial submission to the registry

August 1, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 26, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

3.9 years

First QC Date

August 1, 2023

Last Update Submit

June 3, 2025

Conditions

Depression and Suicide

Keywords

tDCS

Outcome Measures

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"

    Baseline and "Day 19"

Secondary Outcomes (9)

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

    Baseline and "Day 19"

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

    Baseline and "Day 49"

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

    Baseline and "Day 79"

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

    Baseline and "Day 19"

  • Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 49" post-tDCS sessions

    Baseline and "Day 49"

  • +4 more secondary outcomes

Study Arms (1)

Active tDCS

EXPERIMENTAL

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

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationDEVICE

1 stimulation per day during 15 days.

Active tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Nord-Deux-Sèvres

Faye-l'Abbesse, France

RECRUITING

Centre Hospitalier Henri Laborit

Poitiers, France

RECRUITING

MeSH Terms

Conditions

DepressionSuicide

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-Injurious Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Ghina Harika-Germaneau

CONTACT

05.16.52.61.18ghina.harika-germaneau@ch-poitiers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 24, 2023

Study Start

October 26, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 5, 2025

Record last verified: 2025-06

Locations

FR(2)