DepressionChaTNCT05923801

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

A study testing switch to BT electrode position and continue with RUL electrode position in people with Depression, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression
What is being tested?: switch to BT electrode position and continue with RUL electrode position
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 1 siteBelgium
Study dates: 1 Jun 2023to 1 Jun 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pascal Sienaert, MD,PhD contact

+322 758 05 11

pascal.sienaert@upckuleuven.be

Belgium1 site, 1 recruiting

UPC Kortenberg
Kortenberg
Pascal Sienaert, MD, PhD
Recruiting

Other trials in Belgium

About this study

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

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.

Conditions: Depression
Being tested: switch to BT electrode position, continue with RUL electrode position
Keywords: Electroconvulsive Therapy, Depression, Cognition
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

switch to BT electrode positionDevice
use of different electrode positions of ECT device
continue with RUL electrode positionDevice
use of different electrode positions of ECT device

Study groups in NCT05923801
Study group	Role	What they receive
BT ECT	Active comparator	Participants showing no response will be switched to BT ECT until remission is achieved. Receives: Device: switch to BT electrode position
RUL ECT	Active comparator	Participants showing no response will continue with RUL ECT until remission is achieved. Receives: Device: continue with RUL electrode position

What is being measured

The primary outcome is the main question the study is designed to answer.

Change form baseline Depressive Symptom Severity
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Measured: after 4 ECT sessions (2 weeks)
Change form baseline Depressive Symptom Severity
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Measured: after 8 ECT sessions (4 weeks)
Depressive Symptom Severity
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Measured: 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)
Measured: 3 months post-acute course
Autobiographical Memory
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
Measured: after 4 ECT sessions (2 weeks)
Autobiographical Memory
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
Measured: after 8 ECT sessions (4 weeks)
Autobiographical Memory
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
Measured: at the end of acute ECT course (up to 7 weeks)
Autobiographical Memory
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
Measured: 3 months post-acute course

Secondary outcomes (6)

Response/remission status
number of participants with an 50 percent decrease in IDS-score/ IDS-score < 12
Measured: at the end of acute ECT course (up to 7 weeks)
number of ECT treatments needed to achieve response/remission
Measured: at the end of acute ECT course (up to 7 weeks)
Neurocognitive performance (RAVLT)
mean scores on RAVLT (Rey Auditory Verbal Learning Test)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20231 Jun 2026

First posted28 Jun 2023
Study start1 Jun 2023
Primary completion1 Jun 2026 (estimated)
Study completion1 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 196 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05923801
Sponsor's protocol ID: S67329
Acronym: ChaT
Status last verified: Aug 2025
First submitted: 1 Jun 2023
Last updated: 11 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 29436330
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.
PubMed 17074942
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.
PubMed 35048827
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.
PubMed 31774547
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.
PubMed 17146008
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.
PubMed 27418379
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.
PubMed 20673880
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.
PubMed 3314538

Interested in taking part?

Pascal Sienaert, MD,PhD

+322 758 05 11

pascal.sienaert@upckuleuven.be

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05923801
Acronym / sponsor ID: ChaT / S67329
Conditions: Depression
Keywords: Electroconvulsive Therapy, Depression, Cognition
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 196 participants (estimated)
Lead sponsor: Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
Collaborators: Universiteit Antwerpen, AZ Sint-Jan AV, General Hospital Groeninge
Study start: 1 Jun 2023 (actual)
Primary completion: 1 Jun 2026 (estimated)
Study completion: 1 Jun 2026 (estimated)
First posted: 28 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
BT ECT	Active comparator	Device: switch to BT electrode positionParticipants showing no response will be switched to BT ECT until remission is achieved.
RUL ECT	Active comparator	Device: continue with RUL electrode positionParticipants showing no response will continue with RUL ECT until remission is achieved.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
switch to BT electrode positionuse of different electrode positions of ECT device	Device	BT ECT
continue with RUL electrode positionuse of different electrode positions of ECT device	Device	RUL ECT

Primary outcome

Change form baseline Depressive Symptom Severity
Time frame: after 4 ECT sessions (2 weeks)
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Change form baseline Depressive Symptom Severity
Time frame: after 8 ECT sessions (4 weeks)
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Depressive Symptom Severity
Time frame: at the end of acute ECT course (up to 7 weeks)
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Depressive Symptom Severity
Time frame: 3 months post-acute course
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Autobiographical Memory
Time frame: after 4 ECT sessions (2 weeks)
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
Autobiographical Memory
Time frame: after 8 ECT sessions (4 weeks)
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
Autobiographical Memory
Time frame: at the end of acute ECT course (up to 7 weeks)
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
Autobiographical Memory
Time frame: 3 months post-acute course
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)

6 secondary outcomes

Response/remission status
Time frame: at the end of acute ECT course (up to 7 weeks)
number of ECT treatments needed to achieve response/remission
Time frame: at the end of acute ECT course (up to 7 weeks)
Neurocognitive performance (RAVLT)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
Background: PubMed 27780482Kolshus 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.
Background: PubMed 26892939Semkovska 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.
Background: PubMed 20194546Kellner 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.
Background: PubMed 32585354Sackeim 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.
Background: PubMed 21681108Lapidus 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.
Background: PubMed 31104321Birkenhager 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.
Background: PubMed 8733206Rush 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.
Background: PubMed 29436330van 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.
Background: PubMed 17074942Rush 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.
Background: PubMed 35048827Kirov 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.
Background: PubMed 31774547Kellner 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.
Background: PubMed 17146008Kellner 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Pascal Sienaert, MD,PhD contact

+322 758 05 11

pascal.sienaert@upckuleuven.be

Pascal Sienaert, MD, PhD principal investigator

UPC KU Leuven

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing switch to BT electrode position and continue with RUL electrode position in people with Depression, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pascal Sienaert, MD,PhD (+322 758 05 11, pascal.sienaert@upckuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change form baseline Depressive Symptom Severity (time frame: after 4 ECT sessions (2 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05923801, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.