Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID04057378

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

Led by Region Örebro County · Updated on 2025-06-22

800

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the optimal electrical current stimulus during electroconvulsive therapy (ECT) to balance antidepressant effects and memory disturbance in patients with unipolar or bipolar depression. This national, register-based randomized trial compares two pulse widths, 0.5 ms and 1.0 ms, to determine which produces a higher remission rate within one week after treatment. Secondary objectives include assessing self-rated health, memory changes, antidepressive response, number of ECT sessions, hospital readmission, and suicide rates within six months. Participants receive ECT treatment initiated with either a 0.5 ms or a 1.0 ms pulse width stimulus, delivered usually three times per week during the treatment series. Anesthetic doses, electrode placement, and stimulus parameters are adjusted based on seizure quality and clinical response. The study uses a web-based system for randomizing patients by hospital and age group. Evaluations occur weekly during treatment and at six-month follow-up. Participants undergo assessments of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS-S), Clinical Global Impression Scale, and subjective memory ratings before treatment, within one week after treatment, and at six months. Self-rated health is measured with the EQ5D visual analogue scale. Hospital admissions, medication use, social factors, and comorbidities are collected from national registers. Safety data including adverse events and mortality are monitored during and after treatment. The total participation duration includes initial treatment and a six-month follow-up period.

CONDITIONS

Brief Title

Optimal Electrical Stimulus During Electroconvulsive Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old at the time of inclusion
  • Diagnosed with unipolar or bipolar depressive episode according to ICD-10
  • Indicated for and accepts electroconvulsive therapy
  • Has a Swedish personal identity number
  • Capable of giving informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Typically up to 14 days (index series)

Participants receive electroconvulsive therapy (ECT) with either 0.5 ms or 1.0 ms pulse width stimulus, usually three times per week. Clinical and adverse effects are evaluated at least weekly during the treatment period.

Approximately 3 visits per week during treatment

Follow-up

Duration - 6 months

Participants undergo evaluations within 1 week after treatment termination and at 6 month follow-up to assess remission, health status, memory, and readmission or suicide rates.

1 visit within 1 week after treatment and 1 visit at 6 months

Trial Site Locations

Total: 1 location

1

University hospital Örebro

Örebro, Sweden

Actively Recruiting

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Research Team

A

Axel Nordenskjöld, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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