How to Reduce Suicidal Thoughts and Impulsivity in Depression
NCT ID: NCT05894980
Last Updated: 2024-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-09-01
2026-02-28
Brief Summary
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Detailed Description
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With a pilot, prospective, multicenter design, the perspectives of DEPIMPULSE include being able to develop an innovative therapeutic approach in the reduction of risky behaviors, in particular suicidal ideation, associated impulsivity, suicidal risk in patients suffering from depression, while improving our understanding of the behavioral aspects and associated cognitions.
The treatment will be delivered during 5 consecutive days (D1 to D5).
Baseline measures (D0) will be compared to those obtained after the treatment administration (last day of treatment (D5) and 2 weeks (+W2) and 1 month (+W4) after the end of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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active tDCS on left DLPFC
Active tDCS applied on left dorsolateral prefrontal cortex \[DLPFC\]
active tDCS stimulating left DLPFC
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the left DLPFC
active tDCS on right OFC
Active tDCS applied on right orbitofrontal cortex \[OFC\]
active tDCS stimulating right OFC
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the right OFC
sham tDCS
Sham tDCS applied on left dorsolateral prefrontal cortex \[DLPFC\]
sham tDCS
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 0 mA) applied to the left DLPFC
Interventions
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active tDCS stimulating left DLPFC
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the left DLPFC
active tDCS stimulating right OFC
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the right OFC
sham tDCS
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 0 mA) applied to the left DLPFC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* Subject being in the exclusion period of another study or provided for by the "National Volunteer File"
18 Years
ALL
No
Sponsors
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Fondation FondaMental
OTHER
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Djamila BENNABI, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de Besançon
Locations
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CHU de Besançon
Besançon, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital Chenevier, GH Henri Mondor
Créteil, , France
CHU de Montpellier
Montpellier, , France
Countries
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Central Contacts
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Other Identifiers
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2022/724
Identifier Type: -
Identifier Source: org_study_id
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