Assessment of effect of intravenous ketamine in suicidal ideas among patients with major depressive disorder in comparison with control group
Objectives: Effect of intervenous ketamine in suicidal ideation in patients with major depressive disorder is demonstrated as a change in suicidal thoughts in comparison with control group.
Aim: decrease in suicidal thoughts
Design: double blind randomized clinical trial
Setting and conduct: 60 patients suffering from major depression who have been reffered to Ebne Sina hospital will be included in the study. The patients should not use any drug, in the previous month. In order of referral, the patients will be divided into 2 groups A & B using a random number table, which is done by a psychiatrist. The patients are unaware about the treatments. In group A, 0.5 mg/kg Ketamine diluted in 500 cc normal saline will be infused in 30 minutes and in group B 500 cc normal saline without ketamine will be infused. All patients will be in their room steady & calm for 1 hour the vital signs and drug side effects will be checked 2, 24 & 72 hours and 7 days after injection. The criteria will be checked again the person who assess the criteria is also blind of the drug injected to the patient
Statistical analysis: the findings will be analysed by paired t test with SPSS version 21
Major Inclusion and Exclusion criteria: Inclusion criteria: depression diagnosis due to DSM IV criteria; benign major depression episode; suicidal thoughts; no use of antidepression drugs in last month; age above 18
Exclusion criteria: bipolar disorder type 1 & 2; cyclothymia; psychosis having other disorder of 1or 2 axis simultaneusly; drug addiction or withdrawal; medical disease which causes depression; pregnancy; breast feeding; cardiovascular disease history
Intervention: intravenous ketamine
main outcome measures (variables) suicidal thoghts and quantity of deprssion
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015030921397N1
Registration date:2015-07-17, 1394/04/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-17, 1394/04/26
Registrant information
Name
Farah Moayedi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 7897
Email address
moayedi.f@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hormozgan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of intravenous ketamine in suicidal ideas among patients with major depressive disorder in comparison with control group
Public title
Assessment of effect of intravenous ketamine in suicidal ideas among patients with major depressive disorder in comparison with control group
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: depression diagnosis due to DSM IV criteria; benign major depression episode; suicidal thoughts; no use of antidepression drugs in last month; age above 18
Exclusion criteria: bipolar disorder type 1 & 2; cyclothymia; psychosis having other disorder of 1or 2 axis simultaneusly; drug addiction or withdrawal; medical disease which causes depression; pregnancy; breast feeding; cardiovascular disease history
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is done by simple randomization using random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Hormozgan University of Medical Sciences
Street address
Shahid Chamran Boulevard
City
Bandar Abbas
Postal code
7919915519
Approval date
2015-01-27, 1393/11/07
Ethics committee reference number
4/HEC-93-11-7
Health conditions studied
1
Description of health condition studied
Suicide attempt- Depression
ICD-10 code
z91.5, F3
ICD-10 code description
Severe depressive episode without psychotic symptoms, Personal history of self-harm
Primary outcomes
1
Description
The effect of suicidal thoughts
Timepoint
2, 24, 72 hours and 7 day after drug injection
Method of measurement
Beck suicidal ideation questionnaire
Secondary outcomes
1
Description
quantity of depression
Timepoint
2, 24, 72 hours and 7days after drug injectinon
Method of measurement
Beck depression questionaire
Intervention groups
1
Description
Intervention group: 0.5 mg/kg IV ketamine/30 min and the patient is monitored for 2, 24, 72 hrs and 7 days for adverse drug reactions.
Category
Treatment - Drugs
2
Description
Control group: 500 cc IV normal saline as placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne Sina Psychiatric Hospital
Full name of responsible person
Farah Moayedi
Street address
Emam khomeini Boulevard, Bandar Abbas
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hormozgan University of Medical Sciences
Full name of responsible person
Abdol azim Nejati zadeh
Street address
Shahid Mohammadi Hospital, Emam Khomeini Boulvard
City
Bandar Abbas
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Hormozgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hormozgan University Medical Sciences
Full name of responsible person
Farah Moayedi
Position
Psychiatrist
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Emam Khomeini Boulvard, Bandar Abbas
City
Bandar Abbas
Postal code
7919915315
Phone
+98 76 3334 7897
Fax
Email
Moayedi.f@hums.ac.ir; Famoayedi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University Medical Sciences
Full name of responsible person
Farah Moayedi
Position
Psychiatrist
Other areas of specialty/work
Street address
Shahid Mohammadi hospital, Emam Khomeini Boulvard, Bandar Abbas
City
Bandar Abbas
Postal code
7919915315
Phone
+98 76 3334 7897
Fax
Email
Moayedi.F@hums.ac.ir; Famoayedi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University Medical Sciences
Full name of responsible person
Shahrzad Dahtaei
Position
Intern
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Emam Khomeini Boulvard
City
Bandar Abbas
Postal code
7961634199
Phone
+98 763353687
Fax
Email
Atzm1527sh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)