Changing Tactics? Optimizing ECT in Difficult-to-treat Depression
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Contra-indication for general anesthesia
Non-Dutch speaking
Diagnosis of schizoaffective disorder or schizophrenia
Diagnosis of substance use disorder in the past six months
Trial design
Design model
Parallel
Treatments tested in this trial
switch to BT electrode position
Deviceuse of different electrode positions of ECT device
continue with RUL electrode position
Deviceuse of different electrode positions of ECT device
Treatment groups
196 Participants
are divided into 2 treatment groupsGroup A: BT ECTActive comparator 1 intervention
Group B: RUL ECTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change 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)2
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)3
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)4
Depressive Symptom Severity
mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
Time frame
3 months post-acute courseSecondary outcomes
1
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)2
number of ECT treatments needed to achieve response/remission
Time frame
at the end of acute ECT course (up to 7 weeks)3
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 course4
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 courseOther outcomes
1
Clinical characteristics (CORE)
mean scores on CORE
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 course2
Clinical characteristics (PDAS)
mean scores on PDAS
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 courseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Universiteit Antwerpen
Collaborator
AZ Sint-Jan AV
Collaborator
General Hospital Groeninge
Collaborator
Source ClinicalTrials.gov