Protocol summary
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Study aim
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Determining and comparison of anti-depressant effect of oral ketamine, intramuscular ketamine and electroconvulsive therapy in the patients with major depressive disorder
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Design
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A pilot study with a parallel group design of 45 patients, enrolled between October and November 2018 through three weeks, and followed for one month.
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Settings and conduct
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The patients are divided into three 15 individual groups which receive electro convulsive therapy, 1mg/kg oral ketamine and 0.5 mg/kg intramuscular ketamine through 3 weeks in 6-9 sessions. the 17 items Hamilton depression scale(17-HDS) and beck scale for suicidal ideation (BSSI) will be assessed and compared between groups in specific intervals and one month after last intervention. also the satisfaction of each group will be assessed with a questionnaire and compared between groups.
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Participants/Inclusion and exclusion criteria
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Patients with major depressive disorder candidate for electroconvulsive therapy
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Intervention groups
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The severe major depressive patients taking oral ketamine, the severe major depressive patients taking intramuscular ketamine, the severe major depressive patients receiving electrocconvusive therapy
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Main outcome variables
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Determination of anti depressant effect of oral ketamine, intramuscular ketamine in comparison with electroconvulsive therapy
General information
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Reason for update
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Given the low power of the study; and that no similar study has been conducted so far, we would like to introduce this study as a pilot study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090801002266N8
Registration date:
2018-10-31, 1397/08/09
Registration timing:
registered_while_recruiting
Last update:
2020-03-10, 1398/12/20
Update count:
1
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Registration date
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2018-10-31, 1397/08/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-10-12, 1397/07/20
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Expected recruitment end date
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2018-12-11, 1397/09/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of anti-depressant effect of oral ketamine, intramuscular ketamine and electroconvulsive therapy in the patients with major depressive disorder
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Public title
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َAntidepressant effect of ketamine
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Major depressive patients based on DSM 5 criteria candidate for electro convulsive therapy
Age between 18-70 years old
Informed consent form obtained
Exclusion criteria:
Drug side effects which discontinuation is necessary
Patient`s disagreement to stay in study
Deterioration of patient`s symptoms
Not to respond after 4 intervention sessions.
Drug sensitivity
Severe or active hepatic renal cardiac urological disease
Substance abuse
Previous manic or hypo manic episode
Catatonia
Secondary depression due to another medical conditions
History of psychosis
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The selected 45 cases in this study, will be divided in three intervention groups as block randomization, with sealed envelops numbered 1 to 45 in which there is an intervention method, that is randomly selected with computer software.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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In this study the patients divides into three 15 individual groups which receive electro convulsive therapy, 1mg/kg oral ketamine and 0.5 mg/kg intramuscular ketamine through 3 weeks in 6-9 sessions. the 17 items Hamilton depression scale(17-HDS) and beck scale for suicidal ideation (BSSI) will be assessed and compared between groups in specific intervals and one month after last intervention. also the satisfaction of each group will be assessed with a questionnaire and compared between groups.
Ethics committees
1
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Ethics committee
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Approval date
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2017-12-21, 1396/09/30
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Ethics committee reference number
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IR.MUI.REC.1396.3.956
Health conditions studied
1
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Description of health condition studied
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Major depressive disorder
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ICD-10 code
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F33.2
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ICD-10 code description
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Major depressive disorder, recurrent severe without psychotic features
Primary outcomes
1
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Description
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Depression score in hamilton depression scale
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Timepoint
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Before intervention, 24 hours, one week, two weeks, three weeks, four weeks and eight weeks after begining the intervention
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Method of measurement
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Hamilton depression scale-17 items
Secondary outcomes
1
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Description
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Suicidal scores in beck scale for suicidal ideation
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Timepoint
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Before intervention, 24 hours, one week, two weeks, three weeks, four weeks and eight weeks after begining the intervention
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Method of measurement
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Beck scale for sicidal ideation
Intervention groups
1
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Description
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First intervention group: intra muscular ketamine, NMDA antagonist, 0.5mg/kg dosage, 500 mg vial, rotex medica factory in Germany, 6-9 injection through 3weeks
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Category
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Treatment - Drugs
2
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Description
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Second intervention group: intra muscular ketamine, NMDA antagonist, 1mg/kg dosage, 500 mg vial, rotex medica factory in Germany, 6-9 prescription through 3 weeks in which the injectable ketamine will be added to juice and will be taken orally.
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Category
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Treatment - Drugs
3
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Description
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Third intervention group: the bilateral electroconvulsive therapy group that begin with 25mC after short anesthesia in 6-9 sessions through three weeks.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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there is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available