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Optimal Electrical Stimulus During Electroconvulsive Therapy

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated June 22, 2025 (before its estimated November 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study completion date: Nov 15, 2025 to Nov 15, 2027v6
  2. Primary completion date: Nov 15, 2022 to Nov 15, 2025
    • Study completion date: Nov 15, 2024 to Nov 15, 2025
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 1, 2019 to Oct 30, 2019
    v3
  5. Secondary endpoints revised (8)
    • Study description expanded, about 1,279 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04057378
Lead Sponsor Region Örebro County
Conditions
(from sponsor)		 Depressive Disorder, Major, Depression, Bipolar
Related terms Bipolar Disorder, Major Depressive Disorder
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov