Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universiteit Antwerpen | OTHER |
| AZ Sint-Jan AV | OTHER |
| General Hospital Groeninge | OTHER |
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BT ECT | Active Comparator | Participants showing no response will be switched to BT ECT until remission is achieved. |
|
| RUL ECT | Active Comparator | Participants showing no response will continue with RUL ECT until remission is achieved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| switch to BT electrode position | Device | use of different electrode positions of ECT device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change form baseline Depressive Symptom Severity | mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) | after 4 ECT sessions (2 weeks) |
| Change form baseline Depressive Symptom Severity | mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) | after 8 ECT sessions (4 weeks) |
| 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) |
| Depressive Symptom Severity | mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) | 3 months post-acute course |
| Autobiographical Memory | Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF) | after 4 ECT sessions (2 weeks) |
| Autobiographical Memory | Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF) | after 8 ECT sessions (4 weeks) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| number of ECT treatments needed to achieve response/remission |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical characteristics (PDAS) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascal Sienaert, MD,PhD | Contact | +322 758 05 11 | pascal.sienaert@upckuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Pascal Sienaert, MD, PhD | UPC KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPC Kortenberg | Recruiting | Kortenberg | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27780482 | Background | 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. | |
| 26892939 | Background | 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. |
Not provided
Not provided
Details on methodology are noted in the protocol. Questionnaires will be used as stated in their manuals. Data of assessments (informed consent, answers to questionnaires,...) are documented on paper and entered in a data platform (Redcap). When access is provided, or data is exported (using a certain standard format such as .xls or .cvs) it can be reused by other researchers. All data is provided with a clear nomenclature, referring to the scores of standardized questionnaires,cognitive assessment tools, ECT parameters,...
Further, published articles by the involved researchers will contain all details necessary to reveal context of data collection, collection methodology, analytical and procedural information, etc.
The pseudonymized data can be made available upon request, after permission is granted by the principal investigator and the head researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
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 into 2 treatment groups: either continuation with RUL ECT or switch to BT ECT.
Not provided
Not provided
Not provided
| continue with RUL electrode position |
| Device |
use of different electrode positions of ECT device |
|
| Autobiographical Memory | Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF) | 3 months post-acute course |
| at the end of acute ECT course (up to 7 weeks) |
| 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 |
| 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 |
| 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 |
| 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 |
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 |
| 20194546 | Background | 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. |
| 32585354 | Background | 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. |
| 21681108 | Background | 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. |
| 31104321 | Background | 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. |
| 8733206 | Background | 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. |
| 29436330 | Background | 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. |
| 17074942 | Background | 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. |
| 35048827 | Background | 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. |
| 31774547 | Background | 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. |
| 17146008 | Background | 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. |
| 27418379 | Background | 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. |
| 20673880 | Background | 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. |
| 3314538 | Background | 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. |
| 15119910 | Background | 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. |
| 29656263 | Background | 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. |