The purpose of this study determine the effect of the anti depressant effects of ketamine in the treatment of patients with major depressive disorder. Methods and Sampling: clinical trial, simple randomized and single blind. 100 Patients with major depressive disorder according to DSM-V criteria with different severity and with out psychotic feature were selected. This patient also lacks a somatoform disorder and personality disorder co-morbidity, hypertension and heart disease and over the last month are not under medical treatment Randomly selected. In this study Patients into two groups of 50 at a dose of 0.5mg /kg and 0.75mg /kg divided and Each group was divided into two groups of 25 subjects following a single dose of intravenous bolus and infusion for 20 minutes and clinical psychologist at the pre-injection and the second day after injection and were interviewed Beck and Hamilton. More than 50% of patients who have the privilege of testing as respondents considered and again seven days, one month and two months after the administration of the tests turn back. Patients who have a score of less than 50% are considered as non-responders and they began to conventional therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030921072N2
Registration date:2015-04-04, 1394/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-04, 1394/01/15
Registrant information
Name
Farzan Kheirkhah
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
f.khairkhah@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compression the efficacy of ketamine as bolus versus infusion with 0.5 mg /kg and 0.75 mg /kg in treatment of the major depressive disorder.
Public title
Investigation of interavenous Ketamine anti depressant effects on major depressive disorder patients
Purpose
Treatment
Inclusion/Exclusion criteria
Patients with major depressive disorder according to DSM-V criteria with different severity and with out psychotic feature were selected.this patient also lacks a somatoform disorder and personality disorder co-morbidity, hypertension and heart disease and over the last month are not under medical treatment.
Age
From 20 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol College of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2015-03-10, 1393/12/19
Ethics committee reference number
5262
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
Depression
Timepoint
Pre intervension, 2, 7, 30, 60 dayes post intervension
Method of measurement
Hamilton and Beck test
Secondary outcomes
1
Description
Drug dose
Timepoint
Pre intervension, 2, 7, 30, 60 dayes post intervension
Method of measurement
Hamilton and Beck test
2
Description
Method Of Injection
Timepoint
Pre intervension, 2, 7, 30, 60 dayes post intervension
Method of measurement
Hamilton and Beck test
Intervention groups
1
Description
Group 1= Single dose 0.5 mg/kg IV bolus
Category
Treatment - Drugs
2
Description
Group 2= Single dose o.75 mg/kg IV bolus
Category
Treatment - Drugs
3
Description
Group 3= Single dose 0.5 mg/kg IV infusion
Category
Treatment - Drugs
4
Description
Group 4= Single dose 0.75 mg/kg IV infusion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Yahyanejad Hospital
Full name of responsible person
Doctor Gooya Tayyebi
Street address
Shahid Yahyanejad Hospital, Modares Avenue
City
Babol
2
Recruitment center
Name of recruitment center
Psychiatrists' office
Full name of responsible person
Doctor Farzan Kheirkhah
Street address
Building Pasargadae, Shahid Ghasemi Street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences, Research Deputy
Full name of responsible person
ِDoctor Ali Akbar Moghadamnia
Street address
Babol University of Medical Sciences, Ganjafrooz Avenue
City
Babol
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, Research Deputy
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
Shahid Yahyanejad Hospital
Full name of responsible person
Gooya Tayyebi
Position
Resident in Psychiatry
Other areas of specialty/work
Street address
Shahid Yahyanejad Hospital, Modares Avenue
City
Babol
Postal code
4713566547
Phone
+98 11 3229 1951
Fax
+98 981132291951
Email
G.Tayyebi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Farzan Kheirkhah
Position
Associate Professor Of Psychiatry
Other areas of specialty/work
Street address
Babol University Of Medical Sciences, Ganj afrooz Avenue
City
Babol
Postal code
4713566547
Phone
+98 11 3229 1951
Fax
+98 11 3229 1951
Email
Drfarzankh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Yahyanejad Hospital
Full name of responsible person
Gooya Tayyebi
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Shahid Yahyanejad Hospital, Modares Avenue
City
Babol
Postal code
4713566547
Phone
+98 11 3229 1951
Fax
Email
G.Tayyebi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)