Determining the effectiveness of ketamine on suicidal thoughts
Design
Clinical trial, double-blind, phase three, randomized, which will be conducted on 90 patients.
Settings and conduct
The studied population is patients over 18 years of age admitted to the psychiatric department of Shahid Yaheinejad Hospital who have a major depressive episode based on DSM-5 psychiatric clinical interview and have a score of more than 5 on the Beck suicidal ideation scale according to the numerical table method. Randomly divided into two groups by subsidy and intervention will be done on them.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a major depressive episode based on a clinical interview (based on DSM-5)؛ a total score of more than 5 on the Beck Suicidal Thoughts Scale؛ a score of 14 or higher on the Beck Depression Inventory؛ absence of pregnancy or breastfeeding؛ Absence of obvious cognitive impairment or mental retardation
Intervention groups
Intervention group: Ketamine with a dose of 0.75-0.50 mg/kg as a 40-minute infusion.
Control group: 0.9% saline as a 40-minute infusion
Main outcome variables
suicidal ideation Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190317043079N4
Registration date:2023-04-25, 1402/02/05
Registration timing:registered_while_recruiting
Last update:2023-04-25, 1402/02/05
Update count:0
Registration date
2023-04-25, 1402/02/05
Registrant information
Name
farzan kheirkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
f.kheirkhah@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-25, 1402/02/05
Expected recruitment end date
2024-04-24, 1403/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of ketamine and placebo on suicidal ideation
Public title
The effectiveness of ketamine on suicidal ideation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having a major depressive episode based on a clinical interview (based on DSM-5)
A total score of more than 5 on the Beck suicidal ideation scale
A score of 14 or higher in the Beck depression questionnaire
Absence of pregnancy or lactation
Absence of obvious cognitive impairment or mental retardation
Exclusion criteria:
Receiving psychiatric medications within a month before starting ketamine treatment
History of sensitivity to ketamine
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using permutation blocks of size 4 (AABB). Patients will be randomly assigned to two groups of 45 using 25 blocks of size 4 and 1:1 ratio. Creating a random sequence in the blocks will be done by a statistician through the block randomization site
Blinding (investigator's opinion)
Double blinded
Blinding description
The solutions required for infusion (ketamine 0.5mg/kg and ketamine 0.75mg/kg and placebo containing 0.9% saline) are prepared by the pharmacology expert consultant of the project in similar shape, size and color and are available to the specialist assistant of psychiatry who is the project manager. will be placed The solutions are coded separately and only the pharmacology specialist will know about the codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Health research institu-Babol University of Medical Siences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2023-03-12, 1401/12/21
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.292
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F06.32
ICD-10 code description
Mood disorder due to known physiological condition with major depressive-like episode
Primary outcomes
1
Description
Suicidal Ideation
Timepoint
48 hours after receiving the infusion
Method of measurement
Beck scale suicide ideation questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ketamine with a dose of 0.75-0.50 mg/kg as a 40-minute infusion
Category
Treatment - Drugs
2
Description
Control group: 0.9% saline as a 40-minute infusion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahya Nezhad Hospital
Full name of responsible person
Farzan Kheirkhah
Street address
Shahid Mostafa Khomeini St, Modarres St
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3222 5035
Email
f.kheirkhah@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3219 7667
Email
m.rajabnia@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Farzan Kheirkhah
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3233 8301
Email
f.kheirkhah@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farzan Kheirkhah
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3233 8301
Email
f.kheirkhah@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farzan Kheirkhah
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University Of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3233 8301
Email
f.kheirkhah@mubabol.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
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available