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A prospective randomized, single blind, controlled, safety and non-inferiority study of esketamine plus propofol compared to methohexital anesthesia for electroconvulsive therapy
EU CTIS ID: 2024-512210-18-00
What this study is testing
To demonstrate non inferiority of esketamine plus propofol compared to methohexital anesthesia for electroconvulsive therapy in terms of depressive symptom improvement and regarding recovery time following anesthesia
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.