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Recruiting NCT06009523

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

No phase Interventional Depression and Suicide

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial direct current stimulation.
Who it may be relevant to
Registry conditions: Depression and Suicide. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation in Treatment-resistant Depression : a Pilot Study

Overview

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

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

Interventions

  • Device Transcranial direct current stimulation
    1 stimulation per day during 15 days.

Primary outcome measures

  • Change from Baseline in suicidal ideation on the Scale for Suicide Ideation (SSI) at "Day 19" [Time frame: Baseline and "Day 19"]
Secondary outcome measures (9)
  • Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 19" post-tDCS sessions [Time frame: 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 [Time frame: 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 [Time frame: Baseline and "Day 79"]
  • Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 19" post-tDCS sessions [Time frame: Baseline and "Day 19"]
  • Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 49" post-tDCS sessions [Time frame: Baseline and "Day 49"]
  • Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 79" post-tDCS sessions [Time frame: Baseline and "Day 79"]
  • Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 19" post-tDCS sessions [Time frame: Baseline and "Day 19"]
  • Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 49" post-tDCS sessions [Time frame: Baseline and "Day 49"]
  • Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 79" post-tDCS sessions [Time frame: Baseline and "Day 79"]

Eligibility criteria

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 2 centers
  • Centre Hospitalier Nord-Deux-Sèvres — Faye-l'Abbesse
  • Centre Hospitalier Henri Laborit — Poitiers

Identifiers

NCT: NCT06009523 · 2022-A01454-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗