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حالة التجربة السريرية NCT06009523 (tDCS-IDSDEP) لـ الاكتئاب والانتحار هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة

Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation (tDCS-IDSDEP)

قيد التجنيد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06009523 (tDCS-IDSDEP) هي دراسة تدخُّلية لـالاكتئاب والانتحار وهي قيد التجنيد. بدأت في ١١ ربيع الآخر ١٤٤٥ هـ مع خطة لتجنيد ٥٠ مشاركًا. يقودها Centre Hospitalier Henri Laborit، ومن المتوقع اكتمالها بحلول ٣ رجب ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٩ ذو الحجة ١٤٤٦ هـ.
الملخص
The main objective of this study is to demonstrate that 15 transcranial direct current stimulation (tDCS) sessions of 30 minutes at 2 mA intensity are effective to reduce suicidal ideation
وصف مفصل
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening visit to determine eligibility for study entry. Patient who meet the eligibility requirements be able to start the 15 tDCS sessions at the rate of one session per day. After the last session, patients will perform three follow-up visits on D19, D49 and D79
العنوان الرسمي

Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation in Treatment-resistant Depression : a Pilot Study

الحالات الطبية
الاكتئاب والانتحار
معرّفات دراسة أخرى
  • tDCS-IDSDEP
  • 2022-A01454-39
NCT معرّف
تاريخ البدء (فعلي)
2023-10-26
آخر تحديث مُنشور
2025-06-05
تاريخ الاكتمال (المقدر)
2027-12-01
عدد المشاركين المخطط لهم
٥٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
tDCS
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
غ/م
نموذج التدخل
المجموعة الواحدة
التعمية
لا شيء (مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/مجموعةتَدَخُّل/علاج
تجريبيةActive tDCS
Participants received an active tdcs: transcranial direct current with an intensity of 2 mA for 30 minutes
التحفيز بالتيار المباشر عبر الجمجمة
1 stimulation per day during 15 days.
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Change from Baseline in suicidal ideation on the Scale for Suicide Ideation (SSI) at "Day 19"
The main judgment criterion is the evolution of suicidal ideation which is evaluated by the Beck Scale for Suicide Ideation (SSI) between Baseline and "Day 19"
Baseline and "Day 19"
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 19" post-tDCS sessions
The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).
Baseline and "Day 19"
Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 49" post-tDCS sessions
The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).
Baseline and "Day 49"
Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 79" post-tDCS sessions
The Montgomery-Åsberg Depression Rating Scale (MADRS) was developed to provide an assay of depressive symptom severity for use in the investigation of treatment response to antidepressant medication. The MADRS takes 20-60 minutes to be completed by interview. MADRS-S has 9 items , and each item is scored between 0 (minimum) and 6 (maximum). The scores for all 9 items were added, and cutoff scores for the MADRS-S were defined for level of depression (depression: 0-12 = minimal, 13-19 = mild, 20-34 = moderate, ≥ 35 = severe).
Baseline and "Day 79"
Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 19" post-tDCS sessions
The Implicit Association Test (IAT) is a computer-based test measuring implicit mental associations between two concepts. The IAT uses reaction times to categorize stimuli that appear in the middle of the screen into two target categories, in our study: "Death" (suicide, dies, funeral, lifeless, deceased) and "Life". (survive, grow, breathe, alive, live) and/or in two attribute categories "Me" (me, myself, my, mine, I) and "Not Me" (them, they, their, his, others) . and subjects rapidly classify them by pressing one of two keys (the category of right (by pressing the I key) or left (by pressing the E key). According to the logic of the IAT, "D positive" scores represent a strong implicit association between "Me" and "Death". We will use Greenwald's improved algorithm to analyze responses.
Baseline and "Day 19"
Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 49" post-tDCS sessions
The Implicit Association Test (IAT) is a computer-based test measuring implicit mental associations between two concepts. The IAT uses reaction times to categorize stimuli that appear in the middle of the screen into two target categories, in our study: "Death" (suicide, dies, funeral, lifeless, deceased) and "Life". (survive, grow, breathe, alive, live) and/or in two attribute categories "Me" (me, myself, my, mine, I) and "Not Me" (them, they, their, his, others) . and subjects rapidly classify them by pressing one of two keys (the category of right (by pressing the I key) or left (by pressing the E key). According to the logic of the IAT, "D positive" scores represent a strong implicit association between "Me" and "Death". We will use Greenwald's improved algorithm to analyze responses.
Baseline and "Day 49"
Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 79" post-tDCS sessions
The Implicit Association Test (IAT) is a computer-based test measuring implicit mental associations between two concepts. The IAT uses reaction times to categorize stimuli that appear in the middle of the screen into two target categories, in our study: "Death" (suicide, dies, funeral, lifeless, deceased) and "Life". (survive, grow, breathe, alive, live) and/or in two attribute categories "Me" (me, myself, my, mine, I) and "Not Me" (them, they, their, his, others) . and subjects rapidly classify them by pressing one of two keys (the category of right (by pressing the I key) or left (by pressing the E key). According to the logic of the IAT, "D positive" scores represent a strong implicit association between "Me" and "Death". We will use Greenwald's improved algorithm to analyze responses.
Baseline and "Day 79"
Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 19" post-tDCS sessions
The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.
Baseline and "Day 19"
Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 49" post-tDCS sessions
The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.
Baseline and "Day 49"
Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 79" post-tDCS sessions
The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is an indicator of overall health status. The SF-36 is validated and has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, so that the lowest and highest possible scores are 0 and 100, respectively. Lower scores = more disability, higher scores = less disability. Sections : vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.
Baseline and "Day 79"
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  • Age over 18 years
  • Written informed consent
  • Diagnosis of recurrent or isolated depressive episode according to DSM IV criteria (A.P.A. 1994).
  • Stable antidepressant treatment for 3 weeks
  • MADRS score ≥ 20
  • SSI score > 3
  • Subject affiliated to a health insurance system
  • Woman with effective contraception and agreeing to maintain it throughout the study period.

  • Depression with psychotic features Axis I (DSM IV) co-morbid diagnosis of schizophrenia, alcohol and/or other substance dependence (or abuse) (lifetime)
  • Patient who has already undergone an electroconvulsive therapy course for the current episode and does not respond to this treatment
  • Patient deprived of liberty
  • Patient with high suicide risk (item 10 MADRS > 4) in the absence of hospitalization
  • Contraindication to tDCS: intracerebral metallic implant (with the exception of dental implants), cardiac pacemaker, active or non-implanted devices in the region of the head, acute eczema in the planned stimulation area
  • Pregnant, parturient or breastfeeding woman
  • Simultaneous participation in another interventional research
Centre Hospitalier Henri Laborit logoCentre Hospitalier Henri Laborit
جهة اتصال مركزية للدراسة
جهة اتصال: Ghina Harika-Germaneau, 05.16.52.61.18, [email protected]
2 مواقع الدراسة في 1 بلدان
Centre Hospitalier Nord-Deux-Sèvres, Faye-l'Abbesse, France
Issa Wassouf, جهة اتصال, [email protected]
قيد التجنيد
Centre Hospitalier Henri Laborit, Poitiers, France
Ghina Harika-Germaneau, جهة اتصال, [email protected]
قيد التجنيد