Comparison of anti-depressant effect of oral ketamine, intramuscular ketamine and electroconvulsive therapy in the patients with major depressive disorder
Determining and comparison of anti-depressant effect of oral ketamine, intramuscular ketamine and electroconvulsive therapy in the patients with major depressive disorder
Design
Open lable, comparative, clinical trial, with a parallel group design of 45 patients, enrolled between October and November 2018 through three weeks, and followed for one month.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Patients with major depressive disorder candidate for electroconvulsive therapy
Intervention groups
The severe major depressive patients taking oral ketamine, the severe major depressive patients taking intramuscular ketamine, the severe major depressive patients receiving electrocconvusive therapy
Main outcome variables
Determination of anti depressant effect of oral ketamine, intramuscular ketamine in comparison with electroconvulsive therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090801002266N8
Registration date:2018-10-31, 1397/08/09
Registration timing:registered_while_recruiting
Last update:2018-10-31, 1397/08/09
Update count:1
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Gholamreza Kheirabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2135
Email address
kheirabadi@bsrc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2018-12-11, 1397/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anti-depressant effect of oral ketamine, intramuscular ketamine and electroconvulsive therapy in the patients with major depressive disorder
Public title
َAntidepressant effect of ketamine
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics commitee of isfahan university of medical science
Street address
Behavioal science research center, noor hospital, ostandari street, isfahan, iran
City
Isfahan
Province
Isfehan
Postal code
8145831451
Approval date
2017-12-21, 1396/09/30
Ethics committee reference number
IR.MUI.REC.1396.3.956
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F33.2
ICD-10 code description
Major depressive disorder, recurrent severe without psychotic features
Primary outcomes
1
Description
Depression score in hamilton depression scale
Timepoint
Before intervention, 24 hours, one week, two weeks, three weeks, four weeks and eight weeks after begining the intervention
Method of measurement
Hamilton depression scale-17 items
Secondary outcomes
1
Description
Suicidal scores in beck scale for suicidal ideation
Timepoint
Before intervention, 24 hours, one week, two weeks, three weeks, four weeks and eight weeks after begining the intervention
Method of measurement
Beck scale for sicidal ideation
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
Third intervention group: the bilateral electroconvulsive therapy group that begin with 25mC after short anesthesia in 6-9 sessions through three weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Hospital
Full name of responsible person
Gholamreza Kheirabadi
Street address
behavioral sciences research center, Noor hospital, Ostandari Street, Isfahan, Iran
City
isfehan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences, Hezarjerib Street, Isfahan, Iran
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
reasearch@mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Kheirabadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioal science research center, noor hospital, ostandari street, isfahan, iran
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Kheirabadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral sciences research center, Noor hospital, Ostandari Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Kheirabadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral sciences research center, Noor hospital, Ostandari Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD