The main objective of this clinical trial is assessing therapeutic effects of Ketamin on patients with major depression disorder (MDD) who undergo Electroconvulsive therapy (ECT) under general anesthesia. This is a double blind study performing in Shahid Beheshti Psychiatric Hospital. Inclusion criteria are: all patients with MDD subjected to ECT, age 18 – 50. Exclusion criteria: high intracranial pressure (ICP), intracranial tumors, high blood pressure, history of ischemic heart diseases, aneurism in main vessels. Sixty patients with MDD who need ECT will be divided into two groups of 30 ones by means of random numbers table. In first group, Ketamin is administered for inducing anesthesia and in second group Sodium Thiopental is used. In both groups, a psychiatrist who is blind to administered medicine evaluates the patients by The Hamilton Rating Scale for Depression (HRSD) before and after ECT. Other items which will be evaluated are: severity and duration of seizure, recovery time, and blood pressure and heart rate changes. After every two sessions of ECT, HRSD will be evaluated by a psychiatrist who is blind to administered medication, and achieved values of both groups will be compared by statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208159585N2
Registration date:2013-02-07, 1391/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-07, 1391/11/19
Registrant information
Name
Ali Barkhori
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5803
Email address
a_barkhori@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Kerman University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
• Anti depressant effect of Ketamin versus Thiopental Na for ECT in major depression disorder patients
Public title
Assessment of therapeutic effects of Ketamin in treatment of major depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with MDD subjected to ECT who is validated by a psychiatric physician, age 18 – 50. Exclusion criteria: Ketamin contraindication, open eye injuries with high IOP, high ICP, intracranial tumors, tachycardia, high blood pressure, history of ischemic heart diseases, aneurism in main vessels, alcohol and drug consumption within last 3 months, history of Intracranial Hemorrhage(ICH),cardiovascular diseases, unstable medical illnesses, pregnancy, patients older or younger than mentioned age, weight more than 90Kg,allergy to Ketamin, hypo and hyperthyroidism, other mental disorders coexisted with MDD such as dementia and bipolar disorder, patients with pacemakers, patients without informed consent or their family are unreliable.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a double blind clinical trial on 60 patients who undergo Electroconvulsive therapy (ECT). All the patients will sign informed consent but they are blind to the administered medicine. The patients will be divided into two groups of 30 ones by means of random numbers table. A resident of anesthesiology injects the medicine; however the anesthesia technician who controls and records the vital signs and severity of convulsion, and the psychologist who evaluates the patient are unaware of the medication.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Jomhoori Boulevard
City
Kerman
Postal code
Approval date
2012-05-19, 1391/02/30
Ethics committee reference number
k/91/61
Health conditions studied
1
Description of health condition studied
major depression
ICD-10 code
f33.2
ICD-10 code description
Recurrent depressive disorder, current episode severe without psychotic symptoms
2
Description of health condition studied
Major depression
ICD-10 code
f32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
severity of depression
Timepoint
before starting, after second, 4th, 6th session of ECT
Method of measurement
Hamilton questionnaire
Secondary outcomes
1
Description
blood pressure and heart rate
Timepoint
before induction, after ECT, 5, 10, 15 minutes later
Method of measurement
electronic monitoring device
2
Description
duration of seizure
Timepoint
every session
Method of measurement
second
3
Description
recovery time
Timepoint
after administration of anesthetic drugs until the patient's consciousness
Method of measurement
minute
Intervention groups
1
Description
Intervention: Ketamin (50 mg per ml, made by ROTEXMEDICA/Germany) 0.5_1mg/kg, administering stat and IV.
Category
Treatment - Drugs
2
Description
Control: Thiopental Na (50 mg per ml, made by Nani Pharmaceuticals Pvt.Ltd) 3 mg/kg, administering stat and IV.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Psychiatric Hospital
Full name of responsible person
Street address
Jomhori Boulevard
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Kerman University of Medical Sciences
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
Kerman University of Medical Sciences
Full name of responsible person
Behnaz Birjandi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Kerman Bahonar Hospital
City
Kerman
Postal code
7613747181
Phone
+98 34 1223 5011
Fax
+98 34 1223 9188
Email
dr.birjandi_b@yahoo.com
Web page address
www.kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Behnaz Birjandi
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Kerman Bahinar Hospital
City
Kerman
Postal code
7613747181
Phone
+98 34 1211 5780
Fax
+98 34 1223 9188
Email
dr.birjandi_b@yahoo.com
Web page address
www.kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohamad Ali Haghbin
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Kerman Bahonar Hospital
City
Kerman
Postal code
7613747181
Phone
+98 34 1223 5011
Fax
+98 34 1223 9188
Email
m.a.haghbin@gmail.com
Web page address
www.kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)