Acupuncture and Escitalopram for Treating Major Depression Clinical Study

Официальное название

Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial

Обзор

We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.

Подробное описание

This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.

Вмешательства

• Другое acupuncture
  The acupuncture group will receive treatment with needles inserted at the specified acupoints. Selected by acupuncture experts, these acupoints include DU20（Baihui) and SP4 (Gongsun) , PC6 (Neiguan) , PC5 (Jianshi) and LV 3 (Taichong) bilaterally. All acupoints are localized according to the WHO Standard Acupuncture Locations.After needle insertion, the acupuncture needles will be manipulated using either the twirling-rotating or lifting-thrusting methods to achieve the "De Qi" sensation.
• Другое escitalopram
  Patients will receive 10 mg/day of escitalopram for the first 3 weeks and 20mg/day for the remaining 7 weeks.
• Другое sham-acupuncure
  In the sham acupuncture group, superficial skin penetration (2 mm in depth) at nonacupoints will be done without De Qi manipulations. Nonacupoints are away from conventional acupoints or meridians. The choice of sham acupuncture points, which are points located in an emplacement different than the meridian points. The sham acupoints are not standard acupoints and will be about 1cun ( ≈20 mm) lateral from the real acupoints in the experimental group.
• Другое escitalopram placebo
  Patients will receive 10 mg/day of escitalopram placebo for the first 3 weeks and 20mg/day for the remaining 7 weeks.

Первичные конечные точки

• HDRS-17 scale [Срок оценки: from baseline to 10 weeks]

Вторичные конечные точки (4)

• Beck depression inventory scale [Срок оценки: from baseline to 10 weeks]
• The CGI(Clinical Global Impression) scale [Срок оценки: from baseline to 10 weeks]
• The GAD-7(General Anxiety Disorder) scale [Срок оценки: from baseline to 10 weeks]
• The Mini-Mental State Examination (MMSE) scale [Срок оценки: from baseline to 10 weeks]

Критерии участия

Критерии включения

• Between 18 and 75 years of age with no gender-based restriction.
• Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder.
• A Hamilton Rating Scale for Depression (HDRS-17) score ≥ 17
• Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol.
• The absence of acupuncture treatment within at least 1 year.
• Willingness to participate in the trial and provide written informed consent for the clinical trial.

Критерии исключения

• Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth.
• High suicide risk or presenting with suicidal ideation (a score of more than 2 points on the Suicide question of the HDRS-17) at the time of entry.
• Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram.
• Pregnancy or breastfeeding.
• Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture.
• Candidates afraid of needles in general and reluctant to receive acupuncture in particular
• Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency).
• Previous participation in other acupuncture trials.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Jianhua Chen — Шанхай
• Zhenxiang Han — Шанхай
• Zouqing Huang — Шанхай

Публикации

• Yang K, Tiwari S, Liu D, Xu Q, Qi L, Zhu Y, Jiang L, Zouqin H, Wong J, Chen J, Han Z. Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): protocol for a factorial randomised controlled trial. BMJ Open. 2024 Sep 10;14(9):e091214. doi: 10.1136/bmjopen-2024-091214. PMID 39260834

Идентификаторы

NCT: NCT05901571 · PWRl2021-05 · 21Y11921000 · 21ZR1449300

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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