NCT04057378 Optimal Electrical Stimulus During Electroconvulsive Therapy
| NCT ID | NCT04057378 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Region Örebro County |
| Condition | Depressive Disorder, Major |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2019-10-30 |
| Primary Completion | 2025-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 800 participants in total. It began in 2019-10-30 with a primary completion date of 2025-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: • If the investigator judges a certain pulse width to be inappropriate for the patient.
Contact & Investigator
Axel Nordenskjöld
PRINCIPAL INVESTIGATOR
Örebro University, Region Örebro län
Frequently Asked Questions
Who can join the NCT04057378 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depressive Disorder, Major. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04057378 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04057378 currently recruiting?
Yes, NCT04057378 is actively recruiting participants. Contact the research team at axel.nordenskjold@regionorebrolan.se for enrollment information.
Where is the NCT04057378 trial being conducted?
This trial is being conducted at Örebro, Sweden.
Who is sponsoring the NCT04057378 clinical trial?
NCT04057378 is sponsored by Region Örebro County. The principal investigator is Axel Nordenskjöld at Örebro University, Region Örebro län. The trial plans to enroll 800 participants.