Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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