Comparing two electrical pulse widths in electroconvulsive therapy for depression
Compares two electrical stimulus settings during electroconvulsive therapy in adults with depression.
Plain-language title generated from the registry record
Registry title: Optimal Electrical Stimulus During Electroconvulsive Therapy
Key facts
- Where
- Örebro, SwedenSee the site
- Phase
- Phase 4
Where in Sweden
- University Hospital ÖrebroÖrebro, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Örebro County
- Trial code
- NCT04057378
- Record updated
- 22 June 2025
- Original description
SynopsisRead full original descriptionShow less
Optimal Electrical Stimulus During Electroconvulsive Therapy for Depression: a National Register-based Randomized Trial
Synopsis
Aim: The purpose of the study is to determine the stimulus of electrical current during electroconvulsive therapy (ECT) that produces the optimal balance between antidepressant effect and memory disturbance. Specifically, this study aims to compare the 0.5 ms and 1.0 ms pulse width stimuli.
Design: National, register-based randomized trial, unmasked with two treatment arms.
Primary objective: To test the hypothesis that a 1.0 ms pulse width stimulus produces a higher remission rate (< 11 on the MADRS-S) than a 0.5ms pulse width stimulus.
Secondary objectives include testing for differences in:
self-rated global health measured with the EQ5D-VAS subjective memory worsening (increase of 2 on the memory item of the CPRS) antidepressive response (decrease of 50% on the MADRS-S) number of ECTs in the treatment series readmission and suicide rate within 6 months Study population: patients with unipolar or bipolar depression. Sample size: 800 patients, 400 patients in each arm.
Inclusion criteria:
At least 18 years of age at the time of inclusion Diagnostic criteria fulfilled for unipolar, or bipolar depressive episode according to ICD-10.
An indication for and accepting ECT A Swedish personal identity number. Capable of giving informed consent.
Exclusion criteria:
If the investigator judges a certain pulse width to be inappropriate for the patient.
Inclusion time 2019-05-01-2022-11-15.
Abbreviations
1. CGI: Clinical Global Impression Scale 2. CPRS: The Comprehensive Psychopathological Rating Scale 3. ECT: Electroconvulsive therapy 4. EQ5D: EuroQual-group 5 Dimensions Scale 5. ICD-10: International Statistical Classification of Diseases and Related Health Problems. - 10th revision, 6. MADRS-S: Montgomery-Åsberg Depression Rating Scale, self assessed version. 7. Q-ECT: Swedish national quality register for ECT 8. VAS: Visual analogue scale
Inclusion: At least 18 years old at the time of inclusion; Fulfilled diagnostic criteria for unipolar, or bipolar depressive episode according to ICD-10; Has indication for and accepts ECT; Has a Swedish personal identity number; Capable of giving informed consent.
Exclusion: If the investigator judges a certain pulse width to be inappropriate for the patient.