Optimal Electrical Stimulus During Electroconvulsive Therapy

NCT04057378 | Recruiting Phase 4 FDA Device

• 1 other identifier: 269391
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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. 1.CGI: Clinical Global Impression Scale
2. 2.CPRS: The Comprehensive Psychopathological Rating Scale
3. 3.ECT: Electroconvulsive therapy
4. 4.EQ5D: EuroQual-group 5 Dimensions Scale
5. 5.ICD-10: International Statistical Classification of Diseases and Related Health Problems. - 10th revision,
6. 6.MADRS-S: Montgomery-Åsberg Depression Rating Scale, self assessed version.
7. 7.Q-ECT: Swedish national quality register for ECT
8. 8.VAS: Visual analogue scale

Conditions

Depressive Disorder, Major; Depression, Bipolar

Outcome Measures

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.

  within 1 week after treatment termination

Secondary Outcomes (8)

• Self rated health status

  within 1 week after treatment termination

• Subjective memory

  within 1 week after treatment termination

• Antidepressive response

  within 1 week after treatment termination

• Number of sessions

  During index-treatment

• readmission and suicide

  within 6 months

Study Arms (2)

0.5 ms pulse width stimulus

ACTIVE COMPARATOR

Electroconvulsive therapy initiated with 0.5 ms pulse width stimulus

Device: Electroconvulsive therapy

1.0 ms pulse width stimulus

ACTIVE COMPARATOR

Electroconvulsive therapy initiated with 1.0 ms pulse width stimulus

Device: Electroconvulsive therapy

Interventions

Electroconvulsive therapy DEVICE

Electrically induced convulsion under anesthesia

Also known as: ECT

0.5 ms pulse width stimulus; 1.0 ms pulse width stimulus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• If the investigator judges a certain pulse width to be inappropriate for the patient.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

University hospital Örebro

Örebro, Sweden

RECRUITING

Related Links

• Study protocol.

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Study Officials

• Axel Nordenskjöld

  Örebro University, Region Örebro län

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Nordenskjöld, MD, PhD

CONTACT

+46196021000; axel.nordenskjold@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. ECT 1.0 ms pulse width 2. ECT 0.5 ms pulse width

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: October 30, 2019
• Primary Completion: November 15, 2025
• Study Completion (Estimated): November 15, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Supporting information is available now and until the study is reported. Other researchers can access the database subject to ethics approval (below) after the study has been reported.
• Access Criteria: Individual participant data will be available if the research is approved by the Swedish authority Etikprövningsmyndigheten. A collaboration with a Swedish University is recommended.

Locations

SE (1)