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Optimal Electrical Stimulus During Electroconvulsive Therapy

NCT04057378 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-06-22

No results posted yet for this study

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

Conditions

  • Depressive Disorder, Major
  • Depression, Bipolar

Interventions

DEVICE

Electroconvulsive therapy

Electrically induced convulsion under anesthesia

Sponsors & Collaborators

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Axel Nordenskjöld · Örebro University, Region Örebro län

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2025-11-15
Completion
2027-11-15
FDA Device
Yes

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057378 on ClinicalTrials.gov