Clinical trial NCT05923801: Changing Tactics? Optimizing ECT in Difficult-to-treat Depression
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Electroconvulsive Therapy
Depression
Cognition
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: AZ Sint-Jan AV
name: General Hospital Groeninge
First posted: 2023-06-28
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change form baseline Depressive Symptom Severity
timeFrame: after 4 ECT sessions (2 weeks)
measure: Change form baseline Depressive Symptom Severity
timeFrame: after 8 ECT sessions (4 weeks)
measure: Depressive Symptom Severity
timeFrame: at the end of acute ECT course (up to 7 weeks)
measure: Depressive Symptom Severity
timeFrame: 3 months post-acute course
measure: Autobiographical Memory
timeFrame: after 4 ECT sessions (2 weeks)
measure: Autobiographical Memory
timeFrame: after 8 ECT sessions (4 weeks)
measure: Autobiographical Memory
timeFrame: at the end of acute ECT course (up to 7 weeks)
measure: Autobiographical Memory
timeFrame: 3 months post-acute course
Secondary outcomes:
measure: Response/remission status
timeFrame: at the end of acute ECT course (up to 7 weeks)
measure: number of ECT treatments needed to achieve response/remission
timeFrame: at the end of acute ECT course (up to 7 weeks)
measure: Neurocognitive performance (RAVLT)
timeFrame: 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
measure: Neurocognitive performance (MoCA)
timeFrame: 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
measure: Neurocognitive performance (COWAT)
timeFrame: 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
measure: Neurocognitive performance (WMS-R)
timeFrame: 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 outcomes:
measure: Clinical characteristics (CORE)
timeFrame: 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
measure: Clinical characteristics (PDAS)
timeFrame: 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
Locations:
city: Kortenberg
country: Belgium
facility: UPC Kortenberg
Study officials:
affiliation: UPC KU Leuven
name: Pascal Sienaert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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