Changing Tactics? Optimizing ECT in Difficult-to-treat Depression

Официальное название

Changing Tactics? Optimizing ECT in Difficult-to-treat Depression: A Randomized Trial Comparing Continuation of Right Unilateral ECT and Switching to Bitemporal ECT in Case of Early Non-response During an Acute Course of ECT for Difficult-to-treat Depression

Обзор

The goal of this randomized controlled trial is to address which treatment strategy (continue right unilateral (RUL) ECT or switch to bitemporal (BT) ECT speeds up recovery and has the least impact on memory function, in case of early non-response during an acute course of ECT for difficult-to-treat depression. The main questions it aims to answer are: * Assess the antidepressant efficacy and cognitive impact of the continuation of an ongoing treatment with RUL ECT compared to switching the treatment technique to BT ECT, in patients failing to show an early response to an acute course of ECT for major depression; * Assess group and subject-specific trajectories of depressive symptom severity and neurocognitive performance during the acute ECT course and up to 3 months post-treatment. Participants treated with ECT for depression, showing no 'response' (≥50 percent decrease in depressive symptom severity compared to baseline) after 4 treatment sessions, will be randomized to either switch to BT ECT or continue with RUL ECT. Mood and neurocognitive assessments will be performed at baseline, after 4 ECT sessions (before randomization), after 8 ECT sessions, at the end of the acute course and 3 month after the acute course.

Вмешательства

• Устройство switch to BT electrode position
  use of different electrode positions of ECT device
• Устройство continue with RUL electrode position
  use of different electrode positions of ECT device

Первичные конечные точки

• Change form baseline Depressive Symptom Severity [Срок оценки: after 4 ECT sessions (2 weeks)]
• Change form baseline Depressive Symptom Severity [Срок оценки: after 8 ECT sessions (4 weeks)]
• Depressive Symptom Severity [Срок оценки: at the end of acute ECT course (up to 7 weeks)]
• Depressive Symptom Severity [Срок оценки: 3 months post-acute course]
• Autobiographical Memory [Срок оценки: after 4 ECT sessions (2 weeks)]
• Autobiographical Memory [Срок оценки: after 8 ECT sessions (4 weeks)]
• Autobiographical Memory [Срок оценки: at the end of acute ECT course (up to 7 weeks)]
• Autobiographical Memory [Срок оценки: 3 months post-acute course]

Вторичные конечные точки (6)

• Response/remission status [Срок оценки: at the end of acute ECT course (up to 7 weeks)]
• number of ECT treatments needed to achieve response/remission [Срок оценки: at the end of acute ECT course (up to 7 weeks)]
• Neurocognitive performance (RAVLT) [Срок оценки: after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course]
• Neurocognitive performance (MoCA) [Срок оценки: after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course]
• Neurocognitive performance (COWAT) [Срок оценки: after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course]
• Neurocognitive performance (WMS-R) [Срок оценки: after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course]

Критерии участия

Критерии включения

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• Age 18 or older
• Diagnosis of major depressive disorder (DSM-5 296.21-30) or bipolar disorder, depressed (DSM-5 296.51-54; 296.84).

Критерии исключения

• Contra-indication for general anesthesia
• Non-Dutch speaking
• Diagnosis of schizoaffective disorder or schizophrenia
• Diagnosis of substance use disorder in the past six months
• Diagnosis of neurocognitive disorder or intellectual disability alongside a MoCA score <23
• Previous ECT course in the past three months
• Participation in an interventional Trial with an investigational medicinal product or device
• Pregnancy

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• UPC Kortenberg — Kortenberg

Публикации

• Kolshus E, Jelovac A, McLoughlin DM. Bitemporal v. high-dose right unilateral electroconvulsive therapy for depression: a systematic review and meta-analysis of randomized controlled trials. Psychol Med. 2017 Feb;47(3):518-530. doi: 10.1017/S0033291716002737. Epub 2016 Oct 26. PMID 27780482
• Semkovska M, Landau S, Dunne R, Kolshus E, Kavanagh A, Jelovac A, Noone M, Carton M, Lambe S, McHugh C, McLoughlin DM. Bitemporal Versus High-Dose Unilateral Twice-Weekly Electroconvulsive Therapy for Depression (EFFECT-Dep): A Pragmatic, Randomized, Non-Inferiority Trial. Am J Psychiatry. 2016 Apr 1;173(4):408-17. doi: 10.1176/appi.ajp.2015.15030372. Epub 2016 Feb 19. PMID 26892939
• Kellner CH, Knapp R, Husain MM, Rasmussen K, Sampson S, Cullum M, McClintock SM, Tobias KG, Martino C, Mueller M, Bailine SH, Fink M, Petrides G. Bifrontal, bitemporal and right unilateral electrode placement in ECT: randomised trial. Br J Psychiatry. 2010 Mar;196(3):226-34. doi: 10.1192/bjp.bp.109.066183. PMID 20194546
• Sackeim HA, Prudic J, Devanand DP, Nobler MS, Haskett RF, Mulsant BH, Rosenquist PB, McCall WV. The benefits and costs of changing treatment technique in electroconvulsive therapy due to insufficient improvement of a major depressive episode. Brain Stimul. 2020 Sep-Oct;13(5):1284-1295. doi: 10.1016/j.brs.2020.06.016. Epub 2020 Jun 22. PMID 32585354
• Lapidus KA, Kellner CH. When to switch from unilateral to bilateral electroconvulsive therapy. J ECT. 2011 Sep;27(3):244-6. doi: 10.1097/YCT.0b013e31820059e1. No abstract available. PMID 21681108
• Birkenhager TK, Roos J, Kamperman AM. Improvement after two sessions of electroconvulsive therapy predicts final remission in in-patients with major depression. Acta Psychiatr Scand. 2019 Sep;140(3):189-195. doi: 10.1111/acps.13054. Epub 2019 Jun 7. PMID 31104321
• Rush AJ, Gullion CM, Basco MR, Jarrett RB, Trivedi MH. The Inventory of Depressive Symptomatology (IDS): psychometric properties. Psychol Med. 1996 May;26(3):477-86. doi: 10.1017/s0033291700035558. PMID 8733206
• van Diermen L, van den Ameele S, Kamperman AM, Sabbe BCG, Vermeulen T, Schrijvers D, Birkenhager TK. Prediction of electroconvulsive therapy response and remission in major depression: meta-analysis. Br J Psychiatry. 2018 Feb;212(2):71-80. doi: 10.1192/bjp.2017.28. PMID 29436330

Идентификаторы

NCT: NCT05923801 · S67329

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗