How to Reduce Suicidal Thoughts and Impulsivity in Depression
DEPIMPULSE
Controlled Randomized Non-comparative Trial Assessing Active Transcranial Direct Current Stimulation [tDCS] on Left Dorsoleteral Prefrontal Cortex Versus Active tDCS Active on Right Orbitofrontal Cortex to Treat Unipolar Depression
1 other identifier
interventional
100
1 country
4
Brief Summary
The study aims at investigating if tDCS applied to left DLPFC or to right OFC to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedMay 14, 2024
April 1, 2024
1.8 years
May 30, 2023
May 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BSS scores
Difference of Beck's Scale for Suicide Ideation \[BSS\] score between Day 0 and Day 5, and between the arm active tDCS on left DLPFC and the arm active tDCS on right COF. This scale contains 19 items to assess the risk level for suicide among general population. French version of this scale is designed for autovaluation. Each item is quoted from 0 (no suicidal thoughts) to 2 (high degrees of suicidal intent).
Baseline (Day 0), Day 5 (D5)
Secondary Outcomes (11)
BSS scores
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
C-SSRS scores
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
BIS-10 scores
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
UPPS scores
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
BART scores
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
- +6 more secondary outcomes
Study Arms (3)
active tDCS on left DLPFC
EXPERIMENTALActive tDCS applied on left dorsolateral prefrontal cortex \[DLPFC\]
active tDCS on right OFC
ACTIVE COMPARATORActive tDCS applied on right orbitofrontal cortex \[OFC\]
sham tDCS
SHAM COMPARATORSham tDCS applied on left dorsolateral prefrontal cortex \[DLPFC\]
Interventions
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the left DLPFC
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the right OFC
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 0 mA) applied to the left DLPFC
Eligibility Criteria
You may qualify if:
- Man or woman older than 18 years oldRight-handed
- Signed Informed Consent form
- Subject affiliated to or beneficiary from a French social security regime
- Inpatient or outpatient at the Adult Psychiatry Service
- Diagnosis of Major Depressive Disorder according to the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and confirmation by the MINI Structured Clinical Interview
- MADRS score ≥ 18
- Beck Scale for Suicide Ideation (BSS) score ≥8
- Under antidepressant treatment
- Absence of severe progressive neurologic and/or somatic pathologies (specially tumors, degenerative diseases)
You may not qualify if:
- tDCS contraindication
- Younger than 18 years old
- Left-handed
- under mood stabilizer and/or antiepileptic
- treated by ECT or rTMS or tDCS for the current eposide
- Subject under measure of protection or guardianship of justice
- Presence of other psychiatric pahtologies
- Subject beneficiary from a legal protection regime
- Subject unlikely to cooperate or low cooperation stated by investigator
- Subject not covered by social security
- Pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU de Besançon
Besançon, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Hôpital Chenevier, GH Henri Mondor
Créteil, France
CHU de Montpellier
Montpellier, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Djamila BENNABI, MD PhD
CHU de Besançon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2023
First Posted
June 8, 2023
Study Start
September 1, 2023
Primary Completion
July 1, 2025
Study Completion
February 1, 2026
Last Updated
May 14, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share