Changing Tactics? Optimizing ECT in Difficult-to-treat Depression (ChaT)

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 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.

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.

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

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

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

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

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

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

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

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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