Optimal Electrical Stimulus During Electroconvulsive Therapy for Depression: a National Register-based Randomized Trial

Who is this study for? Adult patients with major depressive disorder or bipolar disorder
What treatments are being studied? Electroconvulsive therapy
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
University hospital Örebro
RECRUITING
Örebro
Contact Information
Primary
Axel Nordenskjöld, MD, PhD
axel.nordenskjold@regionorebrolan.se
+46196021000
Time Frame
Start Date: 2019-10-30
Estimated Completion Date: 2027-11-15
Participants
Target number of participants: 800
Treatments
Active_comparator: 0.5 ms pulse width stimulus
Electroconvulsive therapy initiated with 0.5 ms pulse width stimulus
Active_comparator: 1.0 ms pulse width stimulus
Electroconvulsive therapy initiated with 1.0 ms pulse width stimulus
Related Therapeutic Areas
Sponsors
Leads: Region Örebro County

This content was sourced from clinicaltrials.gov

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