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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
196
use of different electrode positions of ECT device
use of different electrode positions of ECT device
UPC Kortenberg
Kortenberg, Belgium
RECRUITINGChange form baseline Depressive Symptom Severity
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Time frame: after 4 ECT sessions (2 weeks)
Change form baseline Depressive Symptom Severity
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Time frame: after 8 ECT sessions (4 weeks)
Depressive Symptom Severity
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Time frame: 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)
Time frame: 3 months post-acute course
Autobiographical Memory
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
Time frame: after 4 ECT sessions (2 weeks)
Autobiographical Memory
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
Time frame: after 8 ECT sessions (4 weeks)
Autobiographical Memory
Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
Time frame: 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)
Time frame: 3 months post-acute course
Response/remission status
number of participants with an 50 percent decrease in IDS-score/ IDS-score \< 12
Time frame: at the end of acute ECT course (up to 7 weeks)
number of ECT treatments needed to achieve response/remission
Time frame: at the end of acute ECT course (up to 7 weeks)
Neurocognitive performance (RAVLT)
mean scores on RAVLT (Rey Auditory Verbal Learning Test)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
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