Status:

UNKNOWN

The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

Lead Sponsor:

First Affiliated Hospital of Chongqing Medical University

Conditions:

Esketamine

ECT

Eligibility:

All Genders

16-45 years

Phase:

EARLY_PHASE1

Brief Summary

A multicenter, randomized, controlled, single blind clinical trial on the efficacy and safety of esmketamine injection in electroconvulsive therapy Objective to evaluate the efficacy and safety of es...

Eligibility Criteria

Inclusion

  • Depressed patients receiving MECT for the first time;
  • 16≤age≤45 years old, no gender limit;
  • The ASA score is I or II;
  • Meet the diagnostic criteria for depression established by APA, and the Hamilton Depression Rating Scale (HDRS-24) score ≥ 35 points;
  • The depressive episode lasts at least 2 weeks;
  • Clearly understand and voluntarily participate in the study, and sign an informed consent form.

Exclusion

  • Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc.
  • There are foreign bodies in the body: such as pacemakers, intracranial electrodes, etc.
  • Those with a history of epilepsy
  • Those who are taking reserpine
  • Acute and systemic infectious diseases, moderate or higher fever
  • History of manic episodes
  • Those who are allergic to anesthetics and muscle relaxants
  • Pregnant women
  • Glaucoma
  • Bipolar disorder, or other mental illnesses, mental retardation
  • Those who judged by the physician in charge to be unsuitable for MECT treatment
  • History of drug abuse

Key Trial Info

Start Date :

August 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2022

Estimated Enrollment :

396 Patients enrolled

Trial Details

Trial ID

NCT04777110

Start Date

August 1 2021

End Date

December 1 2022

Last Update

July 20 2021

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