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

Depression Clinical Trial

— ChaT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923801
• Other study ID #: S67329
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Pascal Sienaert, MD,PhD
• Phone: +322 758 05 11
• Email: pascal.sienaert[@]upckuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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), confirmed by MINI (Mini International Neuropsychiatric Interview)

Exclusion Criteria:

• Contra-indication for general anesthesia
• Non-Dutch speaking
• Diagnosis of schizoaffective disorder or schizophrenia, confirmed by MINI
• Diagnosis of substance use disorder in the past six months, confirmed by MINI
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Belgium	UPC Kortenberg	Kortenberg

Sponsors (4)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	AZ Sint-Jan AV, General Hospital Groeninge, Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

References & Publications (17)

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. — View Citation

Husain MM, Rush AJ, Fink M, Knapp R, Petrides G, Rummans T, Biggs MM, O'Connor K, Rasmussen K, Litle M, Zhao W, Bernstein HJ, Smith G, Mueller M, McClintock SM, Bailine SH, Kellner CH. Speed of response and remission in major depressive disorder with acute electroconvulsive therapy (ECT): a Consortium for Research in ECT (CORE) report. J Clin Psychiatry. 2004 Apr;65(4):485-91. doi: 10.4088/jcp.v65n0406. — View Citation

Kellner CH, Husain MM, Knapp RG, McCall WV, Petrides G, Rudorfer MV, Young RC, Sampson S, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Rosenquist PB, Raza A, Kaliora S, Latoussakis V, Tobias KG, Briggs MC, Liebman LS, Geduldig ET, Teklehaimanot AA, Lisanby SH; CORE/PRIDE Work Group. Right Unilateral Ultrabrief Pulse ECT in Geriatric Depression: Phase 1 of the PRIDE Study. Am J Psychiatry. 2016 Nov 1;173(11):1101-1109. doi: 10.1176/appi.ajp.2016.15081101. Epub 2016 Jul 15. — View Citation

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. — View Citation

Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. doi: 10.1001/archpsyc.63.12.1337. — View Citation

Kellner CH, Obbels J, Sienaert P. When to consider electroconvulsive therapy (ECT). Acta Psychiatr Scand. 2020 Apr;141(4):304-315. doi: 10.1111/acps.13134. Epub 2019 Dec 23. — View Citation

Kirov G, Jauhar S, Sienaert P, Kellner CH, McLoughlin DM. Electroconvulsive therapy for depression: 80 years of progress. Br J Psychiatry. 2021 Nov;219(5):594-597. doi: 10.1192/bjp.2021.37. — View Citation

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. Erratum In: Psychol Med. 2017 Sep 18;:1-2. — View Citation

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. — View Citation

Martinez-Amoros E, Goldberg X, Galvez V, de Arriba-Arnau A, Soria V, Menchon JM, Palao DJ, Urretavizcaya M, Cardoner N. Early improvement as a predictor of final remission in major depressive disorder: New insights in electroconvulsive therapy. J Affect Disord. 2018 Aug 1;235:169-175. doi: 10.1016/j.jad.2018.03.014. Epub 2018 Apr 6. — View Citation

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. — View Citation

Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905. — View Citation

Sackeim HA, Decina P, Kanzler M, Kerr B, Malitz S. Effects of electrode placement on the efficacy of titrated, low-dose ECT. Am J Psychiatry. 1987 Nov;144(11):1449-55. doi: 10.1176/ajp.144.11.1449. — View Citation

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. — View Citation

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. — View Citation

Semkovska M, McLoughlin DM. Objective cognitive performance associated with electroconvulsive therapy for depression: a systematic review and meta-analysis. Biol Psychiatry. 2010 Sep 15;68(6):568-77. doi: 10.1016/j.biopsych.2010.06.009. Epub 2010 Jul 31. — View Citation

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. Erratum In: Br J Psychiatry. 2018 May;212(5):322. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical characteristics (CORE)	mean scores on CORE	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
Other	Clinical characteristics (PDAS)	mean scores on PDAS	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
Primary	Change form baseline Depressive Symptom Severity	mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)	after 4 ECT sessions (2 weeks)
Primary	Change form baseline Depressive Symptom Severity	mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)	after 8 ECT sessions (4 weeks)
Primary	Depressive Symptom Severity	mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)	at the end of acute ECT course (up to 7 weeks)
Primary	Depressive Symptom Severity	mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)	3 months post-acute course
Primary	Autobiographical Memory	Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)	after 4 ECT sessions (2 weeks)
Primary	Autobiographical Memory	Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)	after 8 ECT sessions (4 weeks)
Primary	Autobiographical Memory	Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)	at the end of acute ECT course (up to 7 weeks)
Primary	Autobiographical Memory	Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)	3 months post-acute course
Secondary	Response/remission status	number of participants with an 50 percent decrease in IDS-score/ IDS-score < 12	at the end of acute ECT course (up to 7 weeks)
Secondary	number of ECT treatments needed to achieve response/remission		at the end of acute ECT course (up to 7 weeks)
Secondary	Neurocognitive performance (RAVLT)	mean scores on RAVLT (Rey Auditory Verbal Learning Test)	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
Secondary	Neurocognitive performance (MoCA)	mean scores on MoCA (Montreal Cognitive Assessment)	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
Secondary	Neurocognitive performance (COWAT)	mean scores on COWAT (Controlled Oral Word Association Test)	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
Secondary	Neurocognitive performance (WMS-R)	mean scores on WMS-R (Wechsler Memory Scale) (Cijferreeksen)	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