Evaluation the effectiveness, safety and side effects of Venlafaxine and Bupropione in adult diabetic patients with depression
Design
This randomized clinical trial with control group will be conducted on 60 adult diabetic patients with depression. These patients will be allocated randomly in two groups; intervention group (with Venlafaxine) and control group (with Bupropione).
Settings and conduct
This randomized clinical trial will be implemented in the clinic of endocrinology affiliated to Babol University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 years and over; The presence of depressive symptoms in psychiatric clinical interview; Confirmation of type 2 diabetes mellitus based on diagnosis of research´s endocrinologist.
Exclusion criteria: Pregnancy and breast feeding; Previous history of elevated mood, serious suicidal ideation and dementia
Intervention groups
Intervention group: Venlafaxine manufactured by Abidi´s Pharmaceutical Company 75-150 milligram per day for 12 weeks.
Control group: Bupropione manufactured in Abidi´s Pharmaceutical Company, 150-300 milligram per day for 12 weeks
Main outcome variables
Depressive symptoms; The patients´ blood glucose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150630022991N12
Registration date:2018-08-15, 1397/05/24
Registration timing:registered_while_recruiting
Last update:2018-08-15, 1397/05/24
Update count:0
Registration date
2018-08-15, 1397/05/24
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
2018-08-06, 1397/05/15
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness and side effects of Venlafaxine and Bupropione in diabetic patients with depression
Public title
Venlafaxine and Bupropione in diabetic patients with depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and over
The presence of depressive symptoms in psychiatric clinical interview
Confirmation of type 2 diabetes mellitus based on the diagnosis of research´s endocrinologist
Exclusion criteria:
Pregnancy and breast feeding
Previous history of high mood, serious suicidal ideation and dementia
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation with random numbers table
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, Babol
City
Babol
Province
Mazandaran
Postal code
4136747176
Approval date
2018-07-08, 1397/04/17
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.094
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Depressive symptoms
Timepoint
At baseline and at the end of the 12th week after intervention
Method of measurement
Beck Depression Inventory
2
Description
Blood glucose
Timepoint
At baseline and at the end of the 12th week after intervention