Frontoparietal ECT Group for Major Depressive Episode

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ramsay Clinic Albert Road, Melbourne, Australia
Major Depressive Episode
Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy - Procedure
Eligibility
18+
All Sexes
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Study Summary

Severe depression is devastating for those affected and is often associated with significant risk of suicide. Electroconvulsive therapy (ECT) is a highly effective acute treatment for severe depression, but its use and acceptability are limited by cognitive side effects. Of these, retrograde memory loss is most concerning, and can be long-term. The introduction of ultrabrief right unilateral (UBRUL) ECT into clinical practice has been an important step in reducing the risk of memory impairment, but significant deficits still occur. A new form of UBRUL ECT which utilises a Frontoparietal electrode placement represents a further development. Preliminary data suggest that Frontoparietal UBRUL has good efficacy and less cognitive side effects than UBRUL given using the conventional Temporoparietal electrode placement. Designed as a pivotal trial, this protocol will be the first RCT comparing these two forms of ECT, producing the rigorous efficacy and safety data required to change clinical practice/policy. This is a multicentre, parallel group RCT with 1:1 allocation ratio between Frontoparietal (intervention) and Temporoparietal (comparator) forms of UBRUL ECT. Participation will involve receiving randomised acute ECT under blinded conditions during the randomised acute treatment period (typically around 4 weeks), then completion of a 24-week follow-up period which commences after the cessation of all acute ECT. The study protocol aims to provide 12 randomised acute ECT treatments, though the number of treatments (and hence the length of the randomised acute treatment period) can be adjusted by the participant's own treating/admitting psychiatrist according to their clinical judgement.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Major Depressive Episode

Study Objectives

0 Primary · 12 Secondary · Reporting Duration: After ECT sessions 3 and 6, which typically occur at the end of week 1 and week 2 in the randomised acute treatment phase.

Week 2
Post ECT reorientation time
Week 3
Number of participants switched from randomised treatment to another form of acute ECT
Week 4
Autobiographical Memory Interview-Short Form (AMI-SF) Consistency Scores
From baseline and up to 24-week follow-up
Occurrence of adverse events and serious adverse events
Week 4
Number of responders
Week 4
Change in mean neuropsychological function
Clinical Global Impression-Severity (CGI-S)
Mental Health Questionnaire-14 (MHQ-14)
Number of remitters
Suicidality score
From end of acute ECT treatment up to 24-week follow-up
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
Week 4
Clinical Global Impression-Improvement (CGI-I)

Trial Safety

Safety Progress

1 of 3

Other trials for Major Depressive Episode

Trial Design

2 Treatment Groups

Temporoparietal ECT Group
1 of 2
Frontoparietal ECT Group
1 of 2
Active Control
Experimental Treatment

154 Total Participants · 2 Treatment Groups

Primary Treatment: Frontoparietal ECT Group · No Placebo Group · N/A

Frontoparietal ECT Group
Procedure
Experimental Group · 1 Intervention: Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy · Intervention Types: Procedure
Temporoparietal ECT Group
Procedure
ActiveComparator Group · 1 Intervention: Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after ect sessions 3 and 6, which typically occur at the end of week 1 and week 2 in the randomised acute treatment phase.
Closest Location: Medical College of Georgia, Augusta University · Augusta, GA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Major Depressive Episode
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing and able to participate in research and comply with study requirements.
You are at least 18 years old.\n
You have a score of at least 23 on the Montreal Cognitive Assessment Battery.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.