Determining the effect of intravenous Ketemine on the severity of symptoms of drug-resistant major depressive disorder. Introducing a low-complication and fast treatment method for the treatment of patients with refractory depression.
Design
The clinical trial has a control and control group that uses the rand function of Excel software for randomization
Settings and conduct
Sampling is done among the clients of Shahid Beheshti Hospital clinic and the drug is injected in the operating room of Ayatollah Mousavi Hospital.
Participants/Inclusion and exclusion criteria
Patients are selected from outpatients and hospitalized in Shahid beheshti hospital. Patients aged 25 to 60 years who were diagnosed with mojor depressive disorder based on the DSM-V criteria and did not respond to at least two antidepressants were including in the study.
Intervention groups
One group of patients received a single dose of intravenous Ketamine under the supervision of an anesthesiologist and cardiopulmonary monitor and the control group received a placebo (normal saline) under the same condition.
Main outcome variables
Severity of major depression based on the Montgomery-Asberg scale:
Assessing suicidal ideation based on Beck Suicide Questionnaire
General information
Reason for update
Acronym
MDD
IRCT registration information
IRCT registration number:IRCT20210806052096N1
Registration date:2022-04-09, 1401/01/20
Registration timing:registered_while_recruiting
Last update:2022-04-09, 1401/01/20
Update count:0
Registration date
2022-04-09, 1401/01/20
Registrant information
Name
Farnaz Taherkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4001
Email address
taherkhanifarnaz71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of intravenous Ketemine on the severity of symptoms of treatment resistant depression
Public title
Determining the effect of Ketemine on the treatment resistant depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of major depressive disorder based on DSMV criteria
Failure to respond to at least 2 antidepressants with sufficient therapeutic dose
The criterion of Montgomery-Asberg at least 25
Exclusion criteria:
Having skull masses
Having history of HTN
Having history of IHD
Having a recent or past psychotic disorder
Consumption of recent substances
Pregnancy
Existence of unstable medical disease
Age
From 25 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Clinical interviews were conducted with patients who met the inclusion criteria and a Montgomery-Asberg questionnaire was filled out by them. Next, the patients are divided into two groups; one group receiving a single dose of intravenous ketamine at a rate of 0/5 mg per kg, the other group receiving the same amount of intravenous normal saline. The drug is prepared by an anesthesiologist and is injected by a psychiatrist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Before injecting the drug-Immediately after drug injection-1 hour after drug injection-4 hour after drug injection-1 day after drug injection-3 day after drug injection-7 day after drug injection-1 month after drug injection-2 month after drug injection
Method of measurement
Based on Montgomery-Asberg questionnaire
Secondary outcomes
1
Description
Suicide idea
Timepoint
Before the drug injection-after the drug injection
Method of measurement
Based on the Beck questionnaire
Intervention groups
1
Description
Intervention group: Patients aged 25 to 60 years who were diagnosed with major depressive disorder based on the DSM-V criteria and did not respond to at least 2 antidepressants, receive a dose of intravenous ketamine (half a milligram per kilogram).
Category
Treatment - Drugs
2
Description
Control group: Patients aged 25 to 60 years who were diagnosed with major depressive disorder based on the DSM-V criteria and did not respond to at least 2 antidepressants, receive a dose of intravenous normal saline (half a milligram per kilogram).