Depression
Conditions
Keywords
Electroconvulsive Therapy, Depression, Cognition
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.
Interventions
DEVICEswitch to BT electrode position
use of different electrode positions of ECT device
DEVICEcontinue with RUL electrode position
use of different electrode positions of ECT device
Sponsors
Universitaire Ziekenhuizen KU Leuven
Universiteit Antwerpen
AZ Sint-Jan AV
General Hospital Groeninge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change form baseline Depressive Symptom Severity | after 4 ECT sessions (2 weeks) | mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) |
| Depressive Symptom Severity | at the end of acute ECT course (up to 7 weeks) | mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) |
| Autobiographical Memory | after 4 ECT sessions (2 weeks) | Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response/remission status | at the end of acute ECT course (up to 7 weeks) | number of participants with an 50 percent decrease in IDS-score/ IDS-score \< 12 |
| number of ECT treatments needed to achieve response/remission | at the end of acute ECT course (up to 7 weeks) | — |
| Neurocognitive performance (RAVLT) | 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 | mean scores on RAVLT (Rey Auditory Verbal Learning Test) |
| Neurocognitive performance (MoCA) | 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 | mean scores on MoCA (Montreal Cognitive Assessment) |
| Neurocognitive performance (COWAT) | 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 | mean scores on COWAT (Controlled Oral Word Association Test) |
| Neurocognitive performance (WMS-R) | 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 | mean scores on WMS-R (Wechsler Memory Scale) (Cijferreeksen) |
Countries
Belgium
Contacts
CONTACTPascal Sienaert, MD,PhD
PRINCIPAL_INVESTIGATORPascal Sienaert, MD, PhD
UPC KU Leuven
Outcome results
None listed