Optimal Electrical Stimulus During Electroconvulsive Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Electroconvulsive therapy: Electrically induced convulsion under anesthesia

Study summary

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

Eligibility

Primary outcome measure(s)

• Remission — within 1 week after treatment termination
  To test the hypothesis that a 1.0 ms pulse width produces a higher remission rate (\< 11 on the Montgomery-Åsberg Depression Rating Scale, self assessed version (MADRS-S)) than a 0.5 ms pulse width within 1 week after the treatment series. The scales has 9 items each ranging from 0-6. The score of each item is added together. The maximum total score of the scale is 54, the minimum is 0. Higher scores indicate more severe depressive symptoms.

Trial sites (1)

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