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

Primary Purpose

Depression, Bipolar, Depression, Unipolar, Major Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
S-ketamine
ketamine
saline
Sponsored by
Yan Qiu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Bipolar focused on measuring Electroconvulsive therapy, Depression, S-ketamine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West China Hospital of Sichuan University, Department of Anesthesiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Propofol group

Ketamine group

S-ketamine group

Arm Description

patients were treated with propofol 1 mg/kg and saline bolus infusion before ECT

patients were treated with propofol 1 mg/kg and ketamine 0.5 mg/kg bolus infusion before ECT

patients were treated with propofol 1 mg/kg and S-ketamine 0.25 mg/kg bolus infusion before ECT

Outcomes

Primary Outcome Measures

Hamilton Depression Scale-17 scores
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.
Montgomery-Asberg Depression Rating Scale scores
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.

Secondary Outcome Measures

Hamilton Depression Scale-17 scores
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.
Hamilton Depression Scale-17 scores
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.
Hamilton Depression Scale-17 scores
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.
Montgomery-Asberg Depression Rating Scale scores
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.
Montgomery-Asberg Depression Rating Scale scores
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.
Montgomery-Asberg Depression Rating Scale scores
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.
Mini-mental State Examination scores
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.
Mini-mental State Examination scores
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.
Mini-mental State Examination scores
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.
Mini-mental State Examination scores
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.
suicide
adverse events
Mean heart rate before ECT
patients' vital sign
Mean heart rate after ECT
patients' vital sign
Mean Arterial Pressure before ECT
patients' vital sign
Mean Arterial Pressure after ECT
patients' vital sign
Mean time for return of spontaneous respiration after ECT
time for return of spontaneous respiration after ECT
Mean emergency time after ECT
patients' recovery time after ECT
Mean seizure duration during ECT
patients' seizure duration during ECT

Full Information

First Posted
May 8, 2020
Last Updated
July 19, 2020
Sponsor
Yan Qiu
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1. Study Identification

Unique Protocol Identification Number
NCT04399070
Brief Title
The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT)
Acronym
ECT
Official Title
Effect of S-ketamine on Depressed Patients Undergoing Electroconvulsive Therapy-a Randomized, Double-blind, Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yan Qiu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bipolar, Depression, Unipolar, Major Depressive Disorder, Manic-Depressive - Now Depressed
Keywords
Electroconvulsive therapy, Depression, S-ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol group
Arm Type
Placebo Comparator
Arm Description
patients were treated with propofol 1 mg/kg and saline bolus infusion before ECT
Arm Title
Ketamine group
Arm Type
Active Comparator
Arm Description
patients were treated with propofol 1 mg/kg and ketamine 0.5 mg/kg bolus infusion before ECT
Arm Title
S-ketamine group
Arm Type
Experimental
Arm Description
patients were treated with propofol 1 mg/kg and S-ketamine 0.25 mg/kg bolus infusion before ECT
Intervention Type
Drug
Intervention Name(s)
S-ketamine
Intervention Description
The depression patients received propofol and S-ketamine before ECT
Intervention Type
Drug
Intervention Name(s)
ketamine
Intervention Description
The depression patients received propofol and ketamine before ECT
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
The depression patients received propofol and saline before ECT
Primary Outcome Measure Information:
Title
Hamilton Depression Scale-17 scores
Description
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.
Time Frame
the 1 day after the last ECT
Title
Montgomery-Asberg Depression Rating Scale scores
Description
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.
Time Frame
the 1 day after the last ECT
Secondary Outcome Measure Information:
Title
Hamilton Depression Scale-17 scores
Description
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.
Time Frame
baseline (before first ECT)
Title
Hamilton Depression Scale-17 scores
Description
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.
Time Frame
one week after the first ECT
Title
Hamilton Depression Scale-17 scores
Description
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.
Time Frame
one month after the last ECT
Title
Montgomery-Asberg Depression Rating Scale scores
Description
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.
Time Frame
baseline (before first ECT)
Title
Montgomery-Asberg Depression Rating Scale scores
Description
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.
Time Frame
one week after the first ECT
Title
Montgomery-Asberg Depression Rating Scale scores
Description
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.
Time Frame
one month after the last ECT
Title
Mini-mental State Examination scores
Description
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.
Time Frame
baseline (before first ECT)
Title
Mini-mental State Examination scores
Description
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.
Time Frame
one week after the first ECT
Title
Mini-mental State Examination scores
Description
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.
Time Frame
the 1 day after the last ECT
Title
Mini-mental State Examination scores
Description
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.
Time Frame
one month after the last ECT
Title
suicide
Description
adverse events
Time Frame
times of symptomatic episodes from first ECT up to one month after last ECT
Title
Mean heart rate before ECT
Description
patients' vital sign
Time Frame
5 minutes before each ECT
Title
Mean heart rate after ECT
Description
patients' vital sign
Time Frame
5 minutes after patients emergency from each ECT
Title
Mean Arterial Pressure before ECT
Description
patients' vital sign
Time Frame
5 minutes before each ECT
Title
Mean Arterial Pressure after ECT
Description
patients' vital sign
Time Frame
5 minutes after patients emergency from each ECT
Title
Mean time for return of spontaneous respiration after ECT
Description
time for return of spontaneous respiration after ECT
Time Frame
from end of ECT to return of spontaneous respiration after each ECT
Title
Mean emergency time after ECT
Description
patients' recovery time after ECT
Time Frame
from end of ECT to eye opening or following commands after each ECT
Title
Mean seizure duration during ECT
Description
patients' seizure duration during ECT
Time Frame
from end of electrical stimulus to clonic movements in the right lower limb during each ECT
Other Pre-specified Outcome Measures:
Title
Headache
Description
adverse events
Time Frame
from emergency, assessed up to 24 hours after each ECT
Title
Nausea and vomiting
Description
adverse events
Time Frame
from emergency, assessed up to 24 hours after each ECT
Title
Myalgia
Description
adverse events
Time Frame
from emergency, assessed up to 24 hours after each ECT
Title
Agitation
Description
adverse events
Time Frame
from emergency, assessed up to 1 hour after each ECT
Title
Hallucinations
Description
adverse events
Time Frame
from emergency, assessed up to 3 hours after each ECT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Qiu, Doctor
Phone
+8618980606269
Email
qiuyan_mz@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guizhi Du, Doctor
Phone
+8618980602213
Email
du_guizhi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guizhi Du, Doctor
Organizational Affiliation
West China Hospital of Sichuan University, Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital of Sichuan University, Department of Anesthesiology
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guizhi Du, Doctor
Phone
+86-189-8060-2213
Email
du_guizhi@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT)

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