Unipolar DepressionDEPIMPULSENCT05894980
How to Reduce Suicidal Thoughts and Impulsivity in Depression
A study testing active tDCS stimulating left DLPFC and active tDCS stimulating right OFC in people with Unipolar Depression and Impulsive Behavior, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression, Impulsive Behavior, Suicidal Ideation
- What is being tested?
- active tDCS stimulating left DLPFC and active tDCS stimulating right OFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Sep 2023to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Beck Scale for Suicide Ideation (BSS) score ≥8
- Under antidepressant treatment
- Absence of severe progressive neurologic and/or somatic pathologies (specially tumors, degenerative diseases)
Who cannot join
- 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
Show all 12Show fewer
- 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"
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CHU de Besançon
Besançon
Djamila BENNABI, MD PhD
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Pierre-Michel LLORCA, MD PhD
- Not yet recruiting
Hôpital Chenevier, GH Henri Mondor
Créteil
Mathilde ROSER, MD
- Not yet recruiting
CHU de Montpellier
Montpellier
Philippe COURTET, MD PhD
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Unipolar Depression, Impulsive Behavior, Suicidal Ideation
- Being tested
- active tDCS stimulating left DLPFC, active tDCS stimulating right OFC, sham tDCS
- Keywords
- transcranial stimulation, tDCS, left PreFrontalDorsoLateral Cortex, right OrbitoFrontal Cortex
- Medical subject headings
- Depressive Disorder, Impulsive Behavior, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCS stimulating left DLPFCDevice
Also called Starstim® (Neuroelectrics, Spain)
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the left DLPFC
active tDCS stimulating right OFCDevice
Also called Starstim® (Neuroelectrics, Spain)
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the right OFC
sham tDCSDevice
Also called Starstim® (Neuroelectrics, Spain)
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 0 mA) applied to the left DLPFC
| Study group | Role | What they receive |
|---|---|---|
| active tDCS on left DLPFC | Experimental | Active tDCS applied on left dorsolateral prefrontal cortex [DLPFC] Receives: Device: active tDCS stimulating left DLPFC |
| active tDCS on right OFC | Active comparator | Active tDCS applied on right orbitofrontal cortex [OFC] Receives: Device: active tDCS stimulating right OFC |
| sham tDCS | Sham comparator | Sham tDCS applied on left dorsolateral prefrontal cortex [DLPFC] Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (Day 0), Day 5 (D5)
Secondary outcomes (11)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Sep 2023
- Primary completionJul 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation FondaMental
- Responsible party
- Sponsor
- Investigators
- Djamila BENNABI, MD PhD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894980
- Sponsor's protocol ID
- 2022/724
- Acronym
- DEPIMPULSE
- Status last verified
- Apr 2024
- First submitted
- 30 May 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05894980
- Acronym / sponsor ID
- DEPIMPULSE / 2022/724
- Conditions
- Unipolar Depression, Impulsive Behavior, Suicidal Ideation
- Keywords
- transcranial stimulation, tDCS, left PreFrontalDorsoLateral Cortex, right OrbitoFrontal Cortex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Fondation FondaMental
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active tDCS on left DLPFC | Experimental | Device: active tDCS stimulating left DLPFCActive tDCS applied on left dorsolateral prefrontal cortex [DLPFC] |
| active tDCS on right OFC | Active comparator | Device: active tDCS stimulating right OFCActive tDCS applied on right orbitofrontal cortex [OFC] |
| sham tDCS | Sham comparator | Device: sham tDCSSham tDCS applied on left dorsolateral prefrontal cortex [DLPFC] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active tDCS stimulating left DLPFCAlso: Starstim® (Neuroelectrics, Spain)20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the left DLPFC | Device | active tDCS on left DLPFC |
| active tDCS stimulating right OFCAlso: Starstim® (Neuroelectrics, Spain)20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the right OFC | Device | active tDCS on right OFC |
| sham tDCSAlso: Starstim® (Neuroelectrics, Spain)20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 0 mA) applied to the left DLPFC | Device | sham tDCS |
Primary outcome
BSS scores
Time frame: Baseline (Day 0), Day 5 (D5)
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).
11 secondary outcomes
BSS scores
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
C-SSRS scores
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
BIS-10 scores
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
UPPS scores
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
BART scores
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Cognitive assessment
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Delay discounting with MCQ scores
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Severity of depressive symptoms evaluated by the clinician
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Severity of depressive symptoms evaluated by the patient
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Quality of life measured with the EQ-5D-5L
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Psychological and Physical Pain-Visual Analogic Scale (PPP-VAS)
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Djamila BENNABI, MD PhD principal investigator
CHU de Besançon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS stimulating left DLPFC and active tDCS stimulating right OFC in people with Unipolar Depression and Impulsive Behavior, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Djamila BENNABI, MD PhD (+33381219007, dbennabi@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BSS scores (time frame: Baseline (Day 0), Day 5 (D5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.