The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT) (ECT)

July 19, 2020 updated by: Yan Qiu

Effect of S-ketamine on Depressed Patients Undergoing Electroconvulsive Therapy-a Randomized, Double-blind, Controlled Clinical Study

This study will determine the effectiveness and safety of S-Ketamine in depression patients undergoing electroconvulsive therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Nowadays, depression has become one of the serious mental diseases that affect human's life. With the acceleration of life pace and social pressure, the incidence of depression is increasing year-on-year. According to the statistics of the WHO, by 2017, there were more than 300 million people suffering from depression, accounting for 4.4% of the global population. Depression is highly related to suicide, which is an important reason for suicidal intention and attempt. It has been demonstrated that the incidence of suicide associated with major depression was as high as 15%. The main characteristic of depression is significant and lasting depression, which is caused by the decrease of monoamine transmitters (including dopamine, 5-HT, et al.) related to mood. In the past, antidepressants mainly relied on increasing or reducing the metabolism of transmitters, but these drugs usually took weeks or even months to take effect, and although the symptoms of depression were relieved within weeks after the start of treatment, they were still not ideal in the long term. Therefore, the drug treatment of depression is not optimistic.

Electroconvulsive therapy (ECT), as the first biological therapy introduced into psychiatry, has been improving with the progress of technology and equipment. More studies show that ECT is a safe and effective treatment, and the treatment of severe depression is the first choice in some cases. However, cognitive dysfunction, relapse tendency and related safety after ECT need further study.

Short acting sedatives and muscle relaxants before ECT can minimize the fear and muscle pain caused by ECT induced seizures. Previous sedatives used include propofol, mesaclopidol, thiopental and ketamine. Ketamine can be used for ECT anesthesia in patients with depression because of its good epileptic characteristics and prevention of cognitive dysfunction after ECT. More evidences reveal ketamine has strong antidepressant effect and reduces suicide of patients with treatment-resistant depression or mania. The low dose of ketamine can take effect within one hour, produce rapid antidepressant effect, and can play a role in more than 70% of patients with refractory depression. In addition, even a single intravenous injection of ketamine can effectively reduce the symptoms of depression within 24-72 hours, and may have synergistic antidepressant effect when combined with ECT. Although ketamine is considered to have a significant antidepressant effect in patients with depression, its application in mental disorders remains to be further explored because it may aggravate mental symptoms. However, some studies also found that ketamine did not significantly improve the effect of ECT on depression compared with other anesthetics.

Esketamine is the isomer of ketamine, which mainly acts on NMDA receptor of glutamate and its affinity to the receptor is 3-4 times that of ketamine, therefore it has stronger effect. Evidence suggests that esketamine can regulate NMDA receptor, increase the release of various neurotransmitters, improve the depression of patients, and repair the damaged neurons to improve the neuronal connections in the brain. As an anesthetic, the potency of esketamine is two times higher than ketamine, three times higher than R-ketamine, and its drug metabolism time is shorter, and the related side effects are also significantly reduced. Conseuqently, it has been widely used as an anesthetic in some countries. The efficacy and safety of esketamine nasal spray as a rapid and effective antidepressant in the treatment of patients with refractory depression have been confirmed. However the effect of intravenous esketamine as an anesthetic in ECT anesthesia on patients who are depressed remains unknown. The aim of this study is to evaluate the short-term effect and safety of esketamine as a adjunctive anesthetic in routine ECT anesthesia for patients with depression.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University, Department of Anesthesiology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) Physical Status I-II
  • diagnose depressive disorders with DSM-IV
  • Without cognitive impairment
  • Without ECT in past 6 months

Exclusion Criteria:

  • had other comorbid psychiatric diagnoses, including schizophrenia, mania
  • organic heart diseases, severe hypertension and arrhythmia
  • severe hepatic and renal diseases
  • severe cerebrovascular disorder or malformation, intracranial mass lesions and seizure
  • glaucoma or high intraocular pressure and intra-ocular pathology
  • severe haematological disease, fracture and obesity, pregnancy
  • severe respiratory tract disease or difficult ventilation or incubation
  • had pre-existing neurological disease or cognitive impairment
  • allergy to anesthetics
  • drugs abuse or alcohol addiction
  • family history of malignant hyperthemia
  • refuse to participate in this trial, had taken part in other clinical trial and with less education and couldn't understand the content of questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Propofol group
patients were treated with propofol 1 mg/kg and saline bolus infusion before ECT
Drug: saline
The depression patients received propofol and saline before ECT
Active Comparator: Ketamine group
patients were treated with propofol 1 mg/kg and ketamine 0.5 mg/kg bolus infusion before ECT
Drug: ketamine
The depression patients received propofol and ketamine before ECT
Experimental: S-ketamine group
patients were treated with propofol 1 mg/kg and S-ketamine 0.25 mg/kg bolus infusion before ECT
Drug: S-ketamine
The depression patients received propofol and S-ketamine before ECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Scale-17 scores
Time Frame: the 1 day after the last ECT
the patients' depression were evaluated with Hamilton Depression Scale with 17 questions after ECT. The scores ranged 0-68, and <7 were normal, the higher the score means more serious disease.
the 1 day after the last ECT
Montgomery-Asberg Depression Rating Scale scores
Time Frame: the 1 day after the last ECT
the patients' depression were evaluated with Montgomery-Asberg Depression Rating Scale scores after ECT. The scores ranged 0-60, and <17 were normal, the higher the score means more serious disease.
the 1 day after the last ECT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Scale-17 scores
Time Frame: baseline (before first ECT)
the patients' depression were evaluated with Hamilton Depression Scale with 17 questions before ECT. The scores ranged 0-68, and <7 were normal, the higher the score means more serious disease.
baseline (before first ECT)
Hamilton Depression Scale-17 scores
Time Frame: one week after the first ECT
the patients' depression were evaluated with Hamilton Depression Scale with 17 questions after ECT. The scores ranged 0-68, and <7 were normal, the higher the score means more serious disease.
one week after the first ECT
Hamilton Depression Scale-17 scores
Time Frame: one month after the last ECT
the patients' depression were evaluated with Hamilton Depression Scale with 17 questions after ECT. The scores ranged 0-68, and <7 were normal, the higher the score means more serious disease.
one month after the last ECT
Montgomery-Asberg Depression Rating Scale scores
Time Frame: baseline (before first ECT)
the patients' depression were evaluated with Montgomery-Asberg Depression Rating Scale scores before ECT. The scores ranged 0-60, and <17 were normal, the higher the score means more serious disease.
baseline (before first ECT)
Montgomery-Asberg Depression Rating Scale scores
Time Frame: one week after the first ECT
the patients' depression were evaluated with Montgomery-Asberg Depression Rating Scale scores after ECT. The scores ranged 0-60, and <17 were normal, the higher the score means more serious disease.
one week after the first ECT
Montgomery-Asberg Depression Rating Scale scores
Time Frame: one month after the last ECT
the patients' depression were evaluated with Montgomery-Asberg Depression Rating Scale scores after ECT. The scores ranged 0-60, and <17 were normal, the higher the score means more serious disease.
one month after the last ECT
Mini-mental State Examination scores
Time Frame: baseline (before first ECT)
the patients' cognitive function were evaluated with Mini-mental State Examination scores before ECT. The scores ranged 0-30, and 27-30 were normal, the lower the score means more serious disease.
baseline (before first ECT)
Mini-mental State Examination scores
Time Frame: one week after the first ECT
the patients' cognitive function were evaluated with Mini-mental State Examination scores after ECT. The scores ranged 0-30, and 27-30 were normal, the lower the score means more serious disease.
one week after the first ECT
Mini-mental State Examination scores
Time Frame: the 1 day after the last ECT
the patients' cognitive function were evaluated with Mini-mental State Examination scores after ECT. The scores ranged 0-30, and 27-30 were normal, the lower the score means more serious disease.
the 1 day after the last ECT
Mini-mental State Examination scores
Time Frame: one month after the last ECT
the patients' cognitive function were evaluated with Mini-mental State Examination scores after ECT. The scores ranged 0-30, and 27-30 were normal, the lower the score means more serious disease.
one month after the last ECT
suicide
Time Frame: times of symptomatic episodes from first ECT up to one month after last ECT
adverse events
times of symptomatic episodes from first ECT up to one month after last ECT
Mean heart rate before ECT
Time Frame: 5 minutes before each ECT
patients' vital sign
5 minutes before each ECT
Mean heart rate after ECT
Time Frame: 5 minutes after patients emergency from each ECT
patients' vital sign
5 minutes after patients emergency from each ECT
Mean Arterial Pressure before ECT
Time Frame: 5 minutes before each ECT
patients' vital sign
5 minutes before each ECT
Mean Arterial Pressure after ECT
Time Frame: 5 minutes after patients emergency from each ECT
patients' vital sign
5 minutes after patients emergency from each ECT
Mean time for return of spontaneous respiration after ECT
Time Frame: from end of ECT to return of spontaneous respiration after each ECT
time for return of spontaneous respiration after ECT
from end of ECT to return of spontaneous respiration after each ECT
Mean emergency time after ECT
Time Frame: from end of ECT to eye opening or following commands after each ECT
patients' recovery time after ECT
from end of ECT to eye opening or following commands after each ECT
Mean seizure duration during ECT
Time Frame: from end of electrical stimulus to clonic movements in the right lower limb during each ECT
patients' seizure duration during ECT
from end of electrical stimulus to clonic movements in the right lower limb during each ECT

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache
Time Frame: from emergency, assessed up to 24 hours after each ECT
adverse events
from emergency, assessed up to 24 hours after each ECT
Nausea and vomiting
Time Frame: from emergency, assessed up to 24 hours after each ECT
adverse events
from emergency, assessed up to 24 hours after each ECT
Myalgia
Time Frame: from emergency, assessed up to 24 hours after each ECT
adverse events
from emergency, assessed up to 24 hours after each ECT
Agitation
Time Frame: from emergency, assessed up to 1 hour after each ECT
adverse events
from emergency, assessed up to 1 hour after each ECT
Hallucinations
Time Frame: from emergency, assessed up to 3 hours after each ECT
adverse events
from emergency, assessed up to 3 hours after each ECT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yan Qiu

Investigators

  • Principal Investigator: Guizhi Du, Doctor, West China Hospital of Sichuan University, Department of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • West China Hospital Anes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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