An interventional study of active tDCS stimulating left DLPFC and active tDCS stimulating right OFC in Unipolar Depression, Impulsive Behavior and Suicidal Ideation, sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Treatment
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.
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.
855 studies on the registry are indexed under Depressive Disorder; 159 are open to participants now.
This study's planned enrollment of 100 is above the median of 88 across 689 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 450 studies on the registry; 97 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active tDCS applied on left dorsolateral prefrontal cortex \[DLPFC\]
Device: active tDCS stimulating left DLPFC
Active tDCS applied on right orbitofrontal cortex \[OFC\]
Device: active tDCS stimulating right OFC
Sham tDCS applied on left dorsolateral prefrontal cortex \[DLPFC\]
Device: sham tDCS
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the left DLPFC
Also known as: Starstim® (Neuroelectrics, Spain)
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 2 mA) applied to the right OFC
Also known as: Starstim® (Neuroelectrics, Spain)
20 active tDCS sessions (4 sessions/day for 5 days, 30 min each, 0 mA) applied to the left DLPFC
Also known as: Starstim® (Neuroelectrics, Spain)
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).
Time frame: Baseline (Day 0), Day 5 (D5)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
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
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.
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
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.
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
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)
Likert scales from 0 (none) to 10 (maximum possible pain)
Time frame: Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS
Plan to share: No
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