Comparison the effect of electroconvulsive therapy and intravenous infusion of ketamine on control and relapse of depressive symptoms in depressive cases who are candidate of electro convulsive therapy
In a single blind randomized clinical trial, 40 major depressive cases who referred to ECT selecting with a simple randomization method and will be assigned to 2 case and control grope (20 person in each group). Control group receives 3 time/week bi-temporal ECT until complete symptom remission by a psychiatrist and anesthesiologist (as a routine of treatment with ECT program) who are not in research team. Intervention group receives 3time/ week slow infusion of 0.5mg/kg ketamine until complete symptom remission with direct supervision of an anesthesiologist. Severity of major depressive symptoms will be evaluated in both group using Hamilton Depressive Rating Scale (HDRS) prior to intervention, prior to each intervention session, one week, 1, 2 and 3 month after final intervention session by a psychiatrist who is blind to interventions. Cognitive function evaluate using Adult Wechsler Memory Scale, both group will be evaluated periodically for other potential side effects by a psychiatric resident who is blind to interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104092266N2
Registration date:2011-06-08, 1390/03/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-08, 1390/03/18
Registrant information
Name
Gholamreza Kheirabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2135
Email address
kheirabadi@bsrc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of electroconvulsive therapy and intravenous infusion of ketamine on control and relapse of depressive symptoms in depressive cases who are candidate of electro convulsive therapy
Public title
ketamine role in depression treatment
Purpose
Treatment
Inclusion/Exclusion criteria
IInclusion Criteria:
Known case of major depressive disorder without psychotic feature based on DSM IV-TR who Referred to ECT by a psychiatrist; age between 20-50 years; signing the consent form.
Exclusion Criteria:
History of psychosis or being psychotic; substance abuse during recent 3 months; breast feeding mothers; having medical incapacitating disease such as: renal, hepatic, gastro intestinal, cardiovascular, endocrine, neurologic and hematologic disease based on history and clinical and Para clinical evaluations; history of seizure with unknown origin; uncontrolled hypo or hyper thyroidism ; simultaneous another psychiatric interventions
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ketamin and depression
Secondary trial Id
389328
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avey, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
389328
Health conditions studied
1
Description of health condition studied
Major Depression
ICD-10 code
F32.2
ICD-10 code description
Primary outcomes
1
Description
Severity of major depressive symptoms
Timepoint
prior to each intervention session, one week, 1,2 and 3 month afer intervention
Method of measurement
structured interviewe based on Hamilton Depressive Rating Scale
Secondary outcomes
1
Description
Cognitive Side effects
Timepoint
Prior to intervention, one week and one month after intervention
Method of measurement
Adult Wechsler Memory Scal
Intervention groups
1
Description
Intervention group:receives 3time/ week slow infusion of 0.5mg/kg ketamine until complete symptom remission with direct supervision of an anesthesiologist
Category
Treatment - Drugs
2
Description
Control group: receives 3 time/week bi-temporal ECT until complete symptom remission by a psychiatrist and anesthesiologist
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatric Department, Khorshid hospital, Isfahan University of Medical Sciences