Comparison of bupropion and S citalopram efficacy on depressive symptoms after coronary artery bypass graft surgery at rouhani hospital, Babol in 1398
Design
A randomized clinical trial without control group, with parallel groups, 100 patients randomly divided into two groups of 50 subjects with block sizes of 4 and 6.
Settings and conduct
The population of this study who referred to Ayatollah Rouhani Hospital in Babol. Intervention group 1: Treatment with bupropion (Abidi Co) started at 75 mg and gradually increased to 150 mg daily
Intervention group 2: Treatment with S citalopram (Abidi Co) at a dose of 5 mg and gradually increased to a dose of 20 mg daily.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Coronary artery bypass graft surgery, Willingness to participate in the study
Exclusion Criteria:Patient with cognitive impairment, Mental retardation, History of substance use, Bipolar disorder
Intervention groups
Intervention group 1: Treatment with bupropion (Abidi Co) started at 75 mg and gradually increased to 150 mg daily
Intervention group 2: Treatment with Sitalopram (Abidi Co) at a dose of 5 mg and gradually increased to a dose of 20 mg daily.
Main outcome variables
patient´s depressive condition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190525043700N2
Registration date:2020-07-25, 1399/05/04
Registration timing:registered_while_recruiting
Last update:2020-07-25, 1399/05/04
Update count:0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Romina Hamzehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
r.hamzehpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-15, 1398/12/25
Expected recruitment end date
2020-09-15, 1399/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bupropion and S citalopram efficacy on depressive symptoms after coronary artery bypass graft surgery
Public title
Treatment of depressive symptoms in patients after coronary artery bypass graft surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Coronary artery bypass graft surgery
Willingness to participate in the study
Exclusion criteria:
Patient with cognitive impairment
Mental retardation
History of substance use
Bipolar disorder
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The patients divided randomly with Throw coins into two groups of 50 subjects with four and six blocks and an allocation ratio of 1: 1.The participants allocation sequence in two groups performed with a Randomizer software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.347
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
Primary outcomes
1
Description
patient´s depressive condition
Timepoint
Before intervention (first visit) ,the end of the fourth week (second visit),the end of the eighth week (third visit)
Method of measurement
Beck Depression Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Treatment with bupropion (Abidi Co) started at 75 mg and gradually increased to 150 mg daily
Category
Treatment - Drugs
2
Description
Intervention group2: Treatment with S citalopram (Abidi Co) at a dose of 5 mg and gradually increased to a dose of 20 mg daily.