Optimal Electrical Stimulus During Electroconvulsive Therapy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Örebro County
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Electroconvulsive therapy
DeviceElectrically induced convulsion under anesthesia
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: 0.5 ms pulse width stimulusActive comparator 1 intervention
Group B: 1.0 ms pulse width stimulusActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Remission
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.
Time frame
within 1 week after treatment terminationSecondary outcomes
1
Self rated health status
Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual analogue scale (EQ5D-VAS). The scale ranges from 0-100. Higher scores indicate better health status.
Time frame
within 1 week after treatment termination2
Subjective memory
subjective memory worsening (increase of 2 on the memory item of the Comprehensive Psychopathological Rating Scale (CPRS)). The scale ranges from 0-6. Higher scores indicate more memory disturbances.
Time frame
within 1 week after treatment termination3
Antidepressive response
antidepressive response (decrease of 50% on the MADRS-S). Montgomery-Åsberg Depression Rating Scale, self assessed version (MADRS-S)) 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.
Time frame
within 1 week after treatment termination4
Number of sessions
number of ECTs in the treatment series
Time frame
During index-treatmentSponsors and contacts
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Source ClinicalTrials.gov