The Permanent Effects of double doses of intravenous Es-Ketamine on suicidal thoughts and behaviors in the Major depressive disorder: a randomized double-blind placebo-controlled clinical trial study
To compare suicidal ideation and behaviors between the case and control groups after 24 hours, 7 days,10 and 14 days post infusion.
To compare characteristics including sex, age of onset, duration and episodes and family history of a disease.
To compare symptoms of Major depressive disorder before and 2 weeks after Es-Ketamine or Midazolam infusion.
Design
A randomized double blind placebo controlled clinical trial designed for 90 patients enrolled between May 2019 and March 2020
Settings and conduct
All patients will receive a dose of 0.5mg/Kg of intravenous Es- Ketamin in day 1. Then half of them will receive a dose of 0.045mg/Kg intravenous Midazolaand other will receive a dose of 0.5mg/Kg of Es-Ketamine in day 14.
Drugs will dilute in 100cc normal saline and infuse over 45 minutes by anesthetics and under anesthesiologist supervision.
Suicidal ideation and behavior will be measured using the Beck Scale for Suicide Ideation (BSSI) during the follow-up periods.
The evaluating researcher and the patients will be unaware of the treatment protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are admitted in Hafez and Ebne sina hospitals, Shiraz, with complaints of suicidal ideas and with major depressive disorder, age between 18 and 65 years old.
Exclusion criteria: positive history of alcohol or substance abuse during the past 6 months; mood disorders due to another medical condition; pregnancy or lactation; positive history of Ketamine abuse; psychosis; unstable medical conditions; hypersensitivity to Ketamine or Midazolam and positive history of use of psychotropic agents or drugs like Corticosteroids.
Intervention groups
Infusion of Es-Ketamine Hydrochloride in day 1 and 14 in intervention group and infusion of Es-Ketamine Hydrochloride in day 1 and Midazolam in day 14 in control group.
Main outcome variables
Suicidal idea and behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160105025859N1
Registration date:2019-06-08, 1398/03/18
Registration timing:registered_while_recruiting
Last update:2019-06-08, 1398/03/18
Update count:0
Registration date
2019-06-08, 1398/03/18
Registrant information
Name
Laaya Ahmadzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 9319
Email address
ahmadzadel@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Permanent Effects of double doses of intravenous Es-Ketamine on suicidal thoughts and behaviors in the Major depressive disorder: a randomized double-blind placebo-controlled clinical trial study
Public title
evaluation of s-ketamine effects on reducing suicidal thoughts and behaviors in major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
This clinical trial study will be conducted in Ebne Sina and Hafez Hospital, Shiraz, Iran and all patients who are admitted to our medical care center during a one year period with complaints of suicidal ideas and with a diagnosis of DSM-5 major depressive disorder (MDD),
Exclusion criteria:
Those who have a positive history of alcohol or substance abuse during the past 6 months
mood disorders due to any medical conditions
pregnancy or lactation
those with a positive history of ketamine abuse
those with symptoms of psychosis
unstable medical conditions
with hypersensitivity to ketamine
positive history of use of psychotropic agents or drugs like corticosteroids
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet our inclusion criteria will be randomly allocated into 2 groups using a permuted block randomization method (using blocks of two).
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluating researcher and the patients will be unaware of the treatment protocol. All treatment modalities will be carried out by an independent medical professional. All patients will be followed by a single observer who will solely be responsible for the evaluation of outcomes. This investigator will be unaware of patient treatment and grouping. Patients will be referred to the investigator for evaluation after receiving planned intervention and any information on the intervention program prior to the visit will be controlled by a clinical trial nurse who will be responsible for control of data related to the intervention program.
Placebo
Used
Assignment
Parallel
Other design features
Patients included in the study were all under treatment with SSRIs(selective serotonin reuptake inhibitors) class and if another medication modalities that have confirmed antidepressant effect (such as lithium or ECT) were considered by physician to treat suicidal ideation, they excluded from the study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz university of medical sciences
Street address
Zand Avn.
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-02-19, 1397/11/30
Ethics committee reference number
IR.SUMS.MED.REC.1397.536
Health conditions studied
1
Description of health condition studied
Suicidal thoughts and behaviors
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Suicidal thoughts and behaviors
Timepoint
Patients will be evaluated at baseline (8 hours before infusion), 24 hours, 7 and 10 days and two weeks after each infusions of Es-Ketamine or Midazolam in both groups.
Method of measurement
The Beck Scale for Suicide Ideation (BSSI)
Secondary outcomes
1
Description
Es-Ketamine administration will reduce symptoms of patients with Major Depressive disorder 2weeks post infusion.
Timepoint
before and 2 weeks after Es-Ketamine or Midazolam infusion.
Method of measurement
Hamilton Rating Scale for Depression (HRSD)
Intervention groups
1
Description
Intervention group: Those diagnosed with major depressive disorders who aside to their routine and standard treatment will receive a dose of 0.5mg/Kg of Es-Ketamine Hydrochloride from KETAMIN ROTEXMEDICA injection 50mg/ml, 10 ml, diluted in 100 cc normal saline, during 45 minutes in day 1 and 14.
Category
Treatment - Drugs
2
Description
Control group: Those diagnosed with major depressive disorder who will receive a dose of 0.5mg/Kg of intravenous Es-ketamin in day 1 and a dose of 0.045mg/Kg intravenous MIDAZOLAM ABURIHAN ampul 5mg/ml,1ml, in day 14. all medications will dilute in 100cc normal saline and infuse during 45 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne sina hospital
Full name of responsible person
Laya Ahmadzade
Street address
Hafez Ave.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3228 9601
Email
sinahosp@sums.ac.ir
2
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Laya Ahmadzade
Street address
Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
Hafez@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yunes Ghasemi
Street address
Zand Ave.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Laya Ahmadzade
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Chamran Blvd.,Hafez hospital
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
ahmadzadel@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Laya Ahmadzade
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Chamran Blvd.,Hafez hospital
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
ahmadzadel@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samaneh Rahimi
Position
Resident assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Chamran Blvd.,Hafez hospital
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9531
Email
samane7rahimi86@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
results of the main consequences will share.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
share with Scientific institutions
Under which criteria data/document could be used
for any other researches
From where data/document is obtainable
Contact with samane7rahimi86@yahoo.com
What processes are involved for a request to access data/document
Data will share within 3 months after contact via E-mail