(1) Objectives:This study aimed to evaluate the effectiveness ofl investigates the efficacy of Aspirin as for treating patients with major depressive disorder.(2) Design: General plan of this study is consisted of experimental pre-test and post-test(3) Setting and conduct: 100 patient with major depressive disorder who are able to complete the program will be selected by convenient sampling and will be randomly assigned in two groups: One group receives Sertraline plus aspirin and the other group receives Sertraline plus placebo.(4)Participants including major eligibility criteria: all of patients with major depressive disorder and age between 40 and 80 having cronery artery disease criteria.(5) Interventions: both groups treat with sertraline and treatment group recieve aspirin in addition to sertraline.the patients will be assessed at baseline,week 4, and week 8.(6)Main outcome measures:Beck Depression Inventory is used to measure the outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082829556N1
Registration date:2016-10-10, 1395/07/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-10, 1395/07/19
Registrant information
Name
Hossein Fahimi
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 5531 4908
Email address
fahimi-h@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Siensces
Expected recruitment start date
2016-09-01, 1395/06/11
Expected recruitment end date
2016-11-01, 1395/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aspirin as an augmenting to Sertraline for treating major depressive disorder, a randomized double blind placebo controlled clinical trial
Public title
Aspirin as an augmenting to Sertraline for treating major depressive disorder, a randomized double blind placebo controlled clinical tria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with major depressive disorder according to DSM-VI, both gender, and aged between 40 and 80 years old, Consent to participate in the study by completing the informed consent form, Having risk factors for coronary heart disease or stroke. Exclusion criteria: Depression due to physical illness or drug use, A history of gastric ulcers and contraindications for taking aspirin, pregnant women, History of alcohol and substance abuse within 6 months prior to the beginning of the study, positive history of mania, mental retardation, psychosis, using another antidepressant within 4 weeks prior to starting ASA, Candidates for other treatments such as ECT for depression.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
using Table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences and Health Services
Street address
Pezeshk Blvd, 5th of Qotbe Ravandi Blvd,Vice chancellor for research of Kashan University of Medical Sciences and Health Services
City
Kashan
Postal code
Approval date
2015-06-01, 1394/03/11
Ethics committee reference number
IR.KAUMS.REC.1394.37
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression
Timepoint
baseline,4 week, and8 week
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Sertraline as a serotonin reuptake inhibitor with 150mg daily dosing for 8 week and is production of Dr Abidi pharmacy. and Aspirin (acetyl salysilic acid) 80mg two times per day for 8 week that is production of Dr Abidi pharmacy.
Category
Treatment - Drugs
2
Description
Sertraline as a serotonin reuptake inhibitor with 150mg daily dosing for 8 week and is production of Dr Abidi pharmacy + placebo for 8 week