Comparison of the efficacy of single dose of ketamine injection with multiple doses on reducing the symptoms of patients with refractory depression
Design
Clinical trial with two parallel groups, double-blind, randomized, performed on 30 patients, with Permuted Block Randomization using 4-block blocks and using random number table
Settings and conduct
Patients with refractory depression treated in Kargarnejad Psychiatric Hospital, in two groups; Ketamine injection as a single dose and 6 doses are evaluated. After injecting at the intervals mentioned above, in terms of the severity of depression, the Hamilton questionnaire is checked.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age: 65-18 years old; patients with major depression based on clinical interview based on DSM5 and Hamilton scale; no symptoms of psychosis in the history; patients currently on treatment with other antidepressants should not have their dose or type of medication changed in the last two months. The similarity of antidepressants received by patients in the two groups is considered; no history of addiction or substance abuse in the last 3 months; absence of serious and unstable physical illnesses.
Exclusion criteria: history of one or more seizures; pregnancy or breastfeeding; bipolar disorder; a patient with suicidal thoughts who needs to be hospitalized.
Intervention groups
There are two groups of patients with refractory depression who, as adjunctive therapy, give one group of ketamine in a single dose of 0.5 mg per kilogram and the second group of ketamine in a dose of 6 doses per dose. 0.5 mg per kg is injected twice a week for up to three weeks
Main outcome variables
The main outcome variable is the Hamilton scale score. Eventually, the Hamilton Depression Scale is expected to decline during follow-up
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210125050137N1
Registration date:2021-02-06, 1399/11/18
Registration timing:prospective
Last update:2021-02-06, 1399/11/18
Update count:0
Registration date
2021-02-06, 1399/11/18
Registrant information
Name
suroor karimipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 9111
Email address
karimipour-s@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy comparison of single-dose vs. multi-dose of Ketamine on treatment-resistant depression's symptoms; a non-inferiority RCT study
Public title
The efficacy of Ketamine on treatment-resistant depression's symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Males and females, aged 18 -65 years old
DSM-V Major Depression Disorder diagnosis confirmed by The Hamilton Depression Rating Scale
The patient has refractory depression, a type of major depression that has not responded to traditional treatment options and the first line of treatment and has taken at least 2 trials of antidepressant drug without sufficient response
Exclusion criteria:
Having other psychiatric illnesses other than major depression
Having a history of one or more seizures for no apparent reason
Pregnancy and lactation
Bipolar disorder
Having uncontrolled non-psychiatric illnesses, including cardiovascular disease
Having a history of stimulant use during the last three months
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomized
in two parallel groups by Permuted Block Randomization using (block size = 4) random number table, they receive single or multi dose ketamine .
Blinding (investigator's opinion)
Single blinded
Blinding description
Health care personnel, including physicians, patient care and follow-up, data collection and data analysis officers, have been blinded in this study. The method of drug distribution among patients is block randomization.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotb Ravandi blvd.
City
Kashan
Province
Isfehan
Postal code
8715973446
Approval date
2020-12-30, 1399/10/10
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.194
Health conditions studied
1
Description of health condition studied
Resistant depression
ICD-10 code
F33.9
ICD-10 code description
Major depressive disorder, recurrent, unspecified
Primary outcomes
1
Description
Depression score based on Hamilton scale
Timepoint
Monthly
Method of measurement
Hamilton questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group: patients are treated with a single dose of ketamine. In this group, ketamine is received only once, 50 cc of normal saline, which contains 0.5 mg per kg of body weight of ketamine hydrochloride, by pump or micro set within 40 minutes intravenously. Vial ketamine 10cc / 500 mg used by the company Rotex Medica is German.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group 2: Patients with multiple doses twice a week for up to 3 weeks receive 50 cc of normal saline containing 0.5 mg per kg body weight of ketamine hydrochloride intravenously by pump or micro set for 40 minutes. Ketamine 10cc / 500mg is used by the German company Rotex Medica.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kargarnejad Psychiatric Hospital, Kashan
Full name of responsible person
Suroor Karimipour
Street address
Qutb Ravandi Boulevard, end of Parastar Boulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
karimipour-s@kaums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Qutb Ravandi Boulevard, end of Parastar Boulevard
City
Kashan
Province
Isfehan
Postal code
8731753153
Phone
+98 31 5554 2999
Fax
+98 31 5557 5057
Email
banafshe57@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
10
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
Kashan University of Medical Sciences
Full name of responsible person
Afshin Ahmadvand
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Qutb Ravandi Boulevard, end of Nurse Boulevardvandi blvd.
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
afshin.ahmadvand@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Sepehrmanesh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Qutb Ravandi Boulevard, end of Nurse Boulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
z.sepehrmanesh @gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Suroor Karimipour
Position
Psychiatric Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Qutb Ravandi Boulevard, end of Nurse Boulevard
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9111
Email
karimipour-s@kaums.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
The information of the study participants is confidential
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Participants in the Depression Resistant Patients Project are referred to Kargarnejad Hospital
When the data will become available and for how long
After one year
To whom data/document is available
University professors and assistants
Under which criteria data/document could be used
Evaluate the effects of treatment
From where data/document is obtainable
Research Center of Kashan University Vice Chancellor for Research
What processes are involved for a request to access data/document
Letter from the Vice Chancellor for Student Research and with the approval of the research supervisor