Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05655754

Esketamine Plus Propofol Compared to Methohexital Anesthesia for Electroconvulsive Therapy in Depression: A Randomized, Double Blind, Controlled Study

Led by Medical University of Vienna · Updated on 2025-05-08

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating anesthesia options for patients undergoing electroconvulsive therapy (ECT) to treat severe uni- or bipolar depression. This Phase 4 randomized trial compares a combination of esketamine and propofol (called ketofol) with methohexital, the current standard anesthetic used during ECT at the Medical University of Vienna. The study aims to assess whether ketofol is not inferior to methohexital in terms of anesthesia effects, treatment outcomes, and seizure quality. Participants will be randomly assigned to receive either methohexital or ketofol anesthesia for their entire ECT treatment series. Methohexital is given intravenously at an initial dose of 1 mg/kg with additional doses if needed to achieve adequate anesthesia. Ketofol is prepared by mixing esketamine and propofol and administered intravenously at 0.5 mg/kg each, with extra doses as required. Each anesthesia dose is given shortly before each ECT session. During the 4-week treatment period, participants will undergo assessments including antidepressant effects, recovery and reorientation times, adverse events, cognition, seizure quality, and medication use. Cardiac enzyme levels will be monitored before and after ECT sessions throughout the series. This comprehensive monitoring aims to compare safety and effectiveness profiles of the two anesthetics while ensuring participant well-being throughout the study duration.

CONDITIONS

Brief Title

Comparison of Esketamine/Propofol and Methohexital Anesthesia for ECT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female inpatients
  • Age 18 years or older
  • Diagnosis of severe uni- or bipolar depression (ICD-11 codes F32.2, F32.2, F33.2, F33.3, F31.4, F31.5)
  • Hamilton Depression Rating Scale (HAMD17) score of 24 or higher
  • Ability and willingness to sign informed consent
  • Negative pregnancy test for women
  • Anesthesiological approval for ECT with ASA classification 3 or less
  • Stable antidepressant and antipsychotic medication for at least 7 days before first ECT session
Not Eligible

You will not qualify if you...

  • Severe somatic or neurological diseases, including intracranial hypertension, uncontrolled severe hypertension, bleeding or aneurysm, recent myocardial infarction
  • Current or past diagnosis of schizophrenia or schizoaffective disorder
  • Clinically relevant abnormalities found in physical examination or routine lab tests
  • Pregnancy or breastfeeding
  • Known allergy to study drugs or their components

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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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 - Up to 4 weeks

Participants receive anesthesia with either Methohexital or Esketamine plus Propofol during electroconvulsive therapy (ECT) sessions for depression.

Multiple ECT sessions with anesthesia injections repeated for each session

Follow-up

Duration - Up to 4 weeks after treatment

Participants are monitored for antidepressant effect, recovery time, adverse events, cognition, and seizure quality after the treatment period.

Regular follow-up assessments during the 4-week period

Trial Site Locations

Total: 1 location

1

Pia Baldinger-Melich

Vienna, Austria, 1090

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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