Back to resultsEffects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation (tDCS-IDSDEP)
Primary Purpose
Depression and Suicide
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Depression and Suicide focused on measuring tDCS
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
Sites / Locations
- Centre Hospitalier Nord-Deux-Sèvres
- Centre Hospitalier Henri Laborit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active tDCS
Arm Description
Participants received an active tdcs: transcranial direct current with an intensity of 2 mA for 30 minutes
Outcomes
Primary Outcome Measures
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"
Secondary Outcome Measures
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).
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).
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).
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT06009523
First Posted
August 1, 2023
Last Updated
October 16, 2023
Sponsor
Centre Hospitalier Henri Laborit
1. Study Identification
Unique Protocol Identification Number
NCT06009523
Brief Title
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Acronym
tDCS-IDSDEP
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression and Suicide
Keywords
tDCS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Participants received an active tdcs: transcranial direct current with an intensity of 2 mA for 30 minutes
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
1 stimulation per day during 15 days.
Primary Outcome Measure Information:
Title
Change from Baseline in suicidal ideation on the Scale for Suicide Ideation (SSI) at "Day 19"
Description
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 Outcome Measure Information:
Title
Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 19" post-tDCS sessions
Description
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"
Title
Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 49" post-tDCS sessions
Description
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"
Title
Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 79" post-tDCS sessions
Description
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"
Title
Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 19" post-tDCS sessions
Description
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"
Title
Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 49" post-tDCS sessions
Description
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"
Title
Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 79" post-tDCS sessions
Description
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"
Title
Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 19" post-tDCS sessions
Description
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"
Title
Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 49" post-tDCS sessions
Description
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"
Title
Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 79" post-tDCS sessions
Description
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"
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghina Harika-Germaneau
Phone
05.16.52.61.18
Email
ghina.harika-germaneau@ch-poitiers.fr
Facility Information:
Facility Name
Centre Hospitalier Nord-Deux-Sèvres
City
Faye-l'abbesse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Issa Wassouf
Email
wassouf.issa@chnds.fr
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
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