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

Condition(s) studied

Investigational drug(s) / intervention(s)

switch to BT electrode position: use of different electrode positions of ECT device

continue with RUL electrode position: use of different electrode positions of ECT device

Study 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.

Eligibility

Primary outcome measure(s)

• Change form baseline Depressive Symptom Severity — after 4 ECT sessions (2 weeks)
  mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)
• Change form baseline Depressive Symptom Severity — after 8 ECT sessions (4 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)
• Depressive Symptom Severity — 3 months post-acute course
  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)
• Autobiographical Memory — after 8 ECT sessions (4 weeks)
  Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
• Autobiographical Memory — at the end of acute ECT course (up to 7 weeks)
  Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)
• Autobiographical Memory — 3 months post-acute course
  Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)

Trial sites (1)

More Universitaire Ziekenhuizen KU Leuven trials in Belgium

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