Effects of electroconvulsive therapy using ketamine and propofol as anesthetic agent on the improvement of depression in patients with major depressive disorder
The purpose of this study is to examine the impact of anesthesia with combined Ketamine and Propofol on efficacy of electric shock in patients with major depressive disorder. 50 participants will be recruited from consecutive inpatients, diagnosed to have major depressive disorder by DSM-IV criteria, who were prescribed ECT by their clinicians. Patients undergo administration of either Ketamine (0.3 mg/kg) plus Atropine 0.5 mg (study) or saline plus Atropine 0.5 mg (control) always adjusted to a 2-ml volume according to the patient’s group; Severity of depression will be assessed by the Hamilton Depression Rating Scale (HAM-D) (17-item) and immediate cognitive side effects will be assessed by measuring post –treatment reorientation time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811022935N2
Registration date:2010-09-11, 1389/06/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-09-11, 1389/06/20
Registrant information
Name
Farzin Rezaei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1356 1822
Email address
farrezaei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2010-10-02, 1389/07/10
Expected recruitment end date
2011-10-02, 1390/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of electroconvulsive therapy using ketamine and propofol as anesthetic agent on the improvement of depression in patients with major depressive disorder
Public title
Combined Ketamine and Propofol in electroconvulsive therapy of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) (American Psychiatric Association, 2000), of major depressive disorder, age between 18 to 40 years old, Baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 13, IQ>70
Exclusion criteria: drug or alcohol dependence, any contraindication of ECT, depressive disorder with psychotic features, history of epilepsy, ASA class >2, history of cognitive disorder
Age
From 18 years old to 40 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd
City
Sanandaj
Postal code
Approval date
2010-07-19, 1389/04/28
Ethics committee reference number
46963
Health conditions studied
1
Description of health condition studied
major depressive disorder
ICD-10 code
F33
ICD-10 code description
recurrent depressive disorder
Primary outcomes
1
Description
Severity of depression
Timepoint
baseline and one day after the third and the last ECT session and 2 weeks after the last session
Method of measurement
Hamiltion Depression Rating Scale 17-Item
Secondary outcomes
empty
Intervention groups
1
Description
ketamine (0.3mg/kg) plus Atropine 0.5 mg (study) for induction of anesthesia before injection of Propofol
Category
Treatment - Drugs
2
Description
Saline plus Atropine 0.5 mg for induction of anesthesia before injection of Propofol
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qhods Hospital
Full name of responsible person
Farzin Rezaei
Street address
Pasdaran Blvd- Qhods hospital - Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ataollah Heydari
Street address
Kurdistan university of Medical Sciences, Deputy of research, Pasdaran Blvd., Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?