Finding the best electrical pulse for electroconvulsive therapy in depression
Optimal Electrical Stimulus During Electroconvulsive Therapy for Depression: a National Register-based Randomized Trial
PHASE4 · Region Örebro County · NCT04057378
This study is testing whether a longer electrical pulse during electroconvulsive therapy can help people with depression feel better while causing fewer memory problems.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Örebro County (other) |
| Locations | 1 site (Örebro) |
| Trial ID | NCT04057378 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the optimal electrical pulse width during electroconvulsive therapy (ECT) for patients with major depressive disorder or bipolar disorder. It compares two pulse widths, 0.5 ms and 1.0 ms, to determine which one results in better antidepressant effects while minimizing memory disturbances. The study is a national, register-based randomized trial with 800 participants, divided into two treatment arms, and evaluates various outcomes including remission rates and self-rated health. The primary objective is to see if the 1.0 ms pulse width leads to a higher remission rate compared to the 0.5 ms pulse width within one week after treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with unipolar or bipolar depressive episodes who are indicated for ECT.
Not a fit: Patients who do not meet the diagnostic criteria for depression or those for whom the pulse width is deemed inappropriate by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of electroconvulsive therapy while reducing memory side effects for patients with severe depression.
How similar studies have performed: While there have been studies on ECT, this specific comparison of pulse widths is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Örebro
- University hospital Örebro — Örebro, Sweden (RECRUITING)
Study contacts
- Principal investigator: Axel Nordenskjöld — Örebro University, Region Örebro län
- Study coordinator: Axel Nordenskjöld, MD, PhD
- Email: axel.nordenskjold@regionorebrolan.se
- Phone: +46196021000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depressive Disorder, Major, Depression, Bipolar