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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