Clinical trial NCT06009523: Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation in Treatment-resistant Depression : a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression and Suicide
Keywords: tDCS
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

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

Primary outcomes:
measure: Change from Baseline in suicidal ideation on the Scale for Suicide Ideation (SSI) at "Day 19"
timeFrame: Baseline and "Day 19"
Secondary outcomes:
measure: Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 19" post-tDCS sessions
timeFrame: Baseline and "Day 19"
measure: Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 49" post-tDCS sessions
timeFrame: Baseline and "Day 49"
measure: Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 79" post-tDCS sessions
timeFrame: Baseline and "Day 79"
measure: Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 19" post-tDCS sessions
timeFrame: Baseline and "Day 19"
measure: Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 49" post-tDCS sessions
timeFrame: Baseline and "Day 49"
measure: Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 79" post-tDCS sessions
timeFrame: Baseline and "Day 79"
measure: Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 19" post-tDCS sessions
timeFrame: Baseline and "Day 19"
measure: Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 49" post-tDCS sessions
timeFrame: Baseline and "Day 49"
measure: Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 79" post-tDCS sessions
timeFrame: Baseline and "Day 79"
Other outcomes:
Locations:
city: Faye-l'abbesse
country: France
facility: Centre Hospitalier Nord-Deux-Sèvres
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
References: