Comparing two anesthesia methods for electroconvulsive therapy in depression treatment
A Prospective Randomized, Double Blind, Controlled, Safety and Non-inferiority Study of Esketamine Plus Propofol Compared to Methohexital Anesthesia for Electroconvulsive Therapy
This study tests whether a new combination of anesthesia can work better and be safer than the traditional method for people with severe depression receiving electroconvulsive therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05655754 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and safety of esketamine/propofol versus methohexital anesthesia during electroconvulsive therapy (ECT) for patients with severe depression. The study will involve male and female inpatients aged 18 and older who meet specific diagnostic criteria for depression. Participants will be monitored for various outcomes, including seizure duration, recovery time, and overall treatment efficacy. The goal is to determine if the newer anesthetic combination offers any advantages over the traditional method.
Who should consider this trial
Good fit: Ideal candidates are inpatients aged 18 and older diagnosed with severe uni- or bipolar depression.
Not a fit: Patients with severe somatic or neurological diseases, or those with a history of schizophrenia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia protocols for ECT, enhancing patient recovery and treatment outcomes.
How similar studies have performed: Previous studies comparing ketamine and methohexital have shown inconclusive results, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * male or female inpatients * age ≥ 18 years * ICD-11 diagnosis of severe uni- or bipolar depression (F32.2, F32.2, F33.2, F33.3, F31.4, F31.5) * Hamilton Depression Rating Scale HAMD17 ≥ 24 * ability to understand and willingness to sign written informed consent document * negative urine pregnancy test in women * anesthesiological approval for ECT (Classification of the American Society of Anesthesiologists ASA ≤ 3) * antidepressant and antipsychotic medication in steady state for at least 7 days prior to first ECT treatment Exclusion Criteria: * severe somatic or neurological disease (esp. current or previous history of intracranial hypertension, uncontrolled severe hypertension, bleeds or aneurysm, recent myocardial infarction) * current or past history of schizophrenia or schizoaffective disorder * clinical relevant abnormalities on a general physical examination and routine laboratory screening * pregnancy, breast feeding * known allergy to the study drugs or compounds of the latter
Where this trial is running
Vienna
- Pia Baldinger-Melich — Vienna, Austria (Recruiting)
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.