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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399070
Recruitment Status : Unknown
Verified July 2020 by Yan Qiu, West China Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 22, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Yan Qiu, West China Hospital

Tracking Information
First Submitted Date  ICMJE May 8, 2020
First Posted Date  ICMJE May 22, 2020
Last Update Posted Date July 22, 2020
Estimated Study Start Date  ICMJE August 1, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • suicide [ Time Frame: times of symptomatic episodes from first ECT up to one month after last ECT ]
    adverse events
  • Mean heart rate before ECT [ Time Frame: 5 minutes before each ECT ]
    patients' vital sign
  • Mean heart rate after ECT [ Time Frame: 5 minutes after patients emergency from each ECT ]
    patients' vital sign
  • Mean Arterial Pressure before ECT [ Time Frame: 5 minutes before each ECT ]
    patients' vital sign
  • Mean Arterial Pressure after ECT [ Time Frame: 5 minutes after patients emergency from each ECT ]
    patients' vital sign
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 18, 2020)
  • Headache [ Time Frame: from emergency, assessed up to 24 hours after each ECT ]
    adverse events
  • Nausea and vomiting [ Time Frame: from emergency, assessed up to 24 hours after each ECT ]
    adverse events
  • Myalgia [ Time Frame: from emergency, assessed up to 24 hours after each ECT ]
    adverse events
  • Agitation [ Time Frame: from emergency, assessed up to 1 hour after each ECT ]
    adverse events
  • Hallucinations [ Time Frame: from emergency, assessed up to 3 hours after each ECT ]
    adverse events
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT)
Official Title  ICMJE Effect of S-ketamine on Depressed Patients Undergoing Electroconvulsive Therapy-a Randomized, Double-blind, Controlled Clinical Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression, Bipolar
  • Depression, Unipolar
  • Major Depressive Disorder
  • Manic-Depressive - Now Depressed
Intervention  ICMJE
  • Drug: S-ketamine
    The depression patients received propofol and S-ketamine before ECT
  • Drug: ketamine
    The depression patients received propofol and ketamine before ECT
  • Drug: saline
    The depression patients received propofol and saline before ECT
Study Arms  ICMJE
  • Placebo Comparator: Propofol group
    patients were treated with propofol 1 mg/kg and saline bolus infusion before ECT
    Intervention: Drug: saline
  • Active Comparator: Ketamine group
    patients were treated with propofol 1 mg/kg and ketamine 0.5 mg/kg bolus infusion before ECT
    Intervention: Drug: ketamine
  • Experimental: S-ketamine group
    patients were treated with propofol 1 mg/kg and S-ketamine 0.25 mg/kg bolus infusion before ECT
    Intervention: Drug: S-ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 18, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04399070
Other Study ID Numbers  ICMJE West China Hospital Anes
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Yan Qiu, West China Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yan Qiu
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guizhi Du, Doctor West China Hospital of Sichuan University, Department of Anesthesiology
PRS Account West China Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP