Comparison of the Effectiveness of Sertraline and Fluoxetine in Diabetic Patients with Depression
Design
Randomised controlled parallel group trial
Settings and conduct
Forty adult patients (18 years and above) with clinical diagnosis of diabetes type 2 referring to the endocrinology clinic affiliated to Babol University of Medical Sciences who have been diagnosed as depressive disorder in a clinical psychiatric interview will be allocated randomly in the two case and control groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 18 years and above; Depressive symptoms in a clinical psychiatric interview; Confirmation of diabetes type 2 diagnosed by an endocrinologist
Exclusion Criteria: Pregnancy or lactation; Probability to migrate from the city in duration time of the study; Comorbidity of uncontrolled cardiovascular or ophthalmic diseases
Intervention groups
Intervention Group: Sertraline 50-200 milligram per day for 12 weeks
Control Group: Fluoxetin 20-60 milligram per day for 12 weeks
Main outcome variables
The status of blood glucose in the patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150630022991N9
Registration date:2018-03-10, 1396/12/19
Registration timing:retrospective
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
2017-09-06, 1396/06/15
Actual recruitment end date
2017-10-22, 1396/07/30
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Sertraline and Fluoxetin in Diabetic Patients with Depression
Public title
Sertraline and Fluoxetin in Diabetic Patients with Depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and above
The presence of depressive symptoms in a clinical psychiatric interview
The confirmation of diabetes type 2 diagnosed by an endocrinologist
To provide the informed consent form
Exclusion criteria:
Pregnancy or lactation
Probability to migrate from the city in duration time of the study
Comorbidity of uncontrolled cardiovascular or ophthalmic diseases
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4136747176
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
MUBABOL.REC.1396.16
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Blood Glucose
Timepoint
Baseline and three months after intervention
Method of measurement
Assessment of fasting blood glucose, 2 hours post prandial blood glucose and HbA1C
Secondary outcomes
1
Description
Serum lipid profile
Timepoint
Baseline and three months after intervention
Method of measurement
To test serum triglyceride, cholesterol, HDL and LDL
2
Description
The severity of depression
Timepoint
Baseline and three months after intervention
Method of measurement
Beck Depression Scale
Intervention groups
1
Description
Intervention group: 50-200 milligram per day sertraline manufactured in Doctor Abidi Pharmacy Company
Category
Treatment - Drugs
2
Description
Control group: 20-60 milligram per day fluoxetin for 12 weeks