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De klinische studie NCT05894980 (DEPIMPULSE) voor Unipolaire depressie, Impulsief gedrag, Suïcidale gedachten is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Kaartweergave

How to Reduce Suicidal Thoughts and Impulsivity in Depression (DEPIMPULSE)

Recruterend
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De klinische studie NCT05894980 (DEPIMPULSE) is een interventioneel studie bij Unipolaire depressie, Impulsief gedrag, Suïcidale gedachten met de status recruterend. Het doel is om 100 deelnemers te includeren vanaf 1 september 2023. De studie wordt geleid door Centre Hospitalier Universitaire de Besancon en de voltooiing is gepland op 1 februari 2026. Laatste update op ClinicalTrials.gov: 14 mei 2024.
Beknopte samenvatting
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.
Uitgebreide beschrijving
Depressive disorders are one of the most frequent pathologies in psychiatry. The lifetime prevalence of the characterized depressive episode is indeed particularly high, between 16.6% in the United States and 24.1% in France. Because of this high prevalence, and because they constitute a pathology with a high risk of suicidal behavior (SC), depressive disorders are a major target of medical strategies for suicide prevention. In addition to suicidal ideation, impulsivity, considered as the tendency to express spontaneous, excessive and/or unplanned behaviors, is recognized as being a major factor precipitating SCs.

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.

Officiële titel

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

Aandoeningen
Unipolaire depressieImpulsief gedragSuïcidale gedachten
Andere studie-ID's
  • DEPIMPULSE
  • 2022/724
NCT-ID
Startdatum (Werkelijk)
2023-09-01
Laatste update geplaatst
2024-05-14
Verwachte einddatum
2026-02
Inschrijving (Geschat)
100
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Trefwoorden
transcranial stimulation
tDCS
left PreFrontalDorsoLateral Cortex
right OrbitoFrontal Cortex
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Drievoudig blind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
Experimenteelactive 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
Actieve comparatoractive 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
Schijncomparatorsham tDCS
Sham tDCS applied on left dorsolateral prefrontal cortex \[DLPFC\]
Nep-TDCS
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 0 mA) applied to the left DLPFC
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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)
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
BSS scores
Difference of Beck's Scale for Suicide Ideation \[BSS\] score between Day 0 and Day 5, +W2 and +W4 between the 3 arms 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), Week 2(+W2) and Week 4 (+W4) post-tDCS
C-SSRS scores
Compared scores from the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a clinician-rated tool that evaluates suicidal ideation and behavior. It is composed by 6 "yes/no" questions. High suicide risk is indicated when "yes" is answered to questions 4, 5 or 6.
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
BIS-10 scores
Compared scores from the French version of the Barratt Impulsiveness Scale (BIS-10). The French version of the BIS-10 is a self-rated 34 item questionnaire, composed by three subscales: motor-impulsivity, cognitive-impulsivity and non-planning-impulsivity. Each item is scored on a 0 to 4 points scale. Higher scores indicate higher levels of impulsivity.
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
UPPS scores
Compared scores from the Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency Impulsive Behavior Scale (UPPS-P). The French version of the UPPS-P is a self-rated 45 item scale, evaluating the following components: urgency, lack of premeditation, lack of perseverance and sensation seeking. Each item is scored on a base of 4 points. Higher scores indicate higher levels of impulsivity.
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
BART scores
Balloon Analogue Risk Task (BART), assessing risk-taking behavior
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Cognitive assessment
Compared results from the experimental TEA, assessing cognitive functions.
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Delay discounting with MCQ scores
Compared scores from the French version of the Monetary Choice Questionnaire (MCQ). The MCQ is a self-rated 27 item questionnaire which assessed the discounting. Delay discounting is the decline in the present value of a reward with delay to its receipt. Example item: " Would you prefer 25€ today or 75€ in 15 days? " For each item, subjects must choose between a low immediate reward and a higher delayed reward. Waiting times vary from 7 days to 186 days, and rewards are divided into 3 magnitudes: low (25-35€), medium (50-60€), high (75-85€). This will allow assessing: the influence of the the magnitude of the difference between the two rewards proposed, the impact of the time on the reward's subjective value (speed at which the reward is devalued over time), reflected in the k index. This index is calculated separately for each magnitude, and an average index is calculated for each subject. The more the k index is high, the more the subject is considered impulsive.
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Severity of depressive symptoms evaluated by the clinician
Score achieved on the validated clinician questionnaire Quick Inventory of Depressive Symptomatology (QIDS-C16) evaluating the severity of depressive symptoms. The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Severity of depressive symptoms evaluated by the patient
Score achieved on the validated self-reported (QIDS-SR16) evaluating the severity of depressive symptoms. QIDS-SR-16 is a standard questionnaire "The Quick Inventory of Depressive Symptomatology" (16-Item) (Self-Report). This covers questions on falling asleep, sleep during the night, waking up , sleeping too much, feeling sad ,appetite, weight, concentration , how they view themselves, thoughts of death and suicide, general interests, energy levels, feeling slowed down , feeling restless.
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Quality of life measured with the EQ-5D-5L
Quality of life measured with the EQ-5D-5L
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Psychological and Physical Pain-Visual Analogic Scale (PPP-VAS)
Likert scales from 0 (none) to 10 (maximum possible pain)
Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • 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)

  • 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
  • Subject being in the exclusion period of another study or provided for by the "National Volunteer File"
Centre Hospitalier Universitaire de Besancon logoCentre Hospitalier Universitaire de Besancon
Fondation FondaMental logoFondation FondaMental
Centraal Contactpersoon
Contact: Djamila BENNABI, MD PhD, +33381219007, [email protected]
Contact: Magali NICOLIER, PhD, +33381219007, [email protected]
4 Studielocaties in 1 landen
CHU de Besançon, Besançon, France
Djamila BENNABI, MD PhD, Hoofdonderzoeker
Recruterend
CHU de Clermont-Ferrand, Clermont-Ferrand, France
Pierre-Michel LLORCA, MD PhD, Hoofdonderzoeker
Recruterend
Hôpital Chenevier, GH Henri Mondor, Créteil, France
Mathilde ROSER, MD, Hoofdonderzoeker
Nog niet rekruterend
CHU de Montpellier, Montpellier, France
Philippe COURTET, MD PhD, Hoofdonderzoeker
Nog niet rekruterend