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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Device: switch to BT electrode position
* Device: continue with RUL electrode position


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BT ECT<br>Participants showing no response will be switched to BT ECT until remission is achieved. | Device: switch to BT electrode position<br>* use of different electrode positions of ECT device<br>|
| Active Comparator: RUL ECT<br>Participants showing no response will continue with RUL ECT until remission is achieved. | Device: continue with RUL electrode position<br>* use of different electrode positions of ECT device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 
| Autobiographical Memory | Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF) | 3 months post-acute course | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroconvulsive Therapy, Depression, Cognition