Protocol summary

Summary
This 6 week randomized controlled clinical trial investigates the safety and efficacy of Aspirin as an augmentation with citalopram for treating patients with major depressive disorder. This study includes 60 patients. One group receives citalopram plus aspirin and the other group receives citalopram plus placebo. Hamilton Depression rating scale is used to measure the outcome.the patients will be assessed at baseline, week 2, and week 6.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306203930N27
Registration date: 2013-07-16, 1392/04/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-07-16, 1392/04/25
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciecnes
Expected recruitment start date
2013-06-17, 1392/03/27
Expected recruitment end date
2014-06-17, 1393/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aspirin as an augmenting to citlaopram for treating major depressive disorder, a randomized double blind placebo controlled clinical trial
Public title
Aspirin for treating depression, a randomized double blind controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with major depressive disorder according to DSM-VI, both gender, and aged between 17 and 70 years old. Exclusion criteria: receive NSAIDs concurrently, reported positive history of cancer, serious medical condition, and hypothyroidism.
Age
From 17 years old to 70 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
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
Shiraz University of Medical Sceinces
Street address
Shiraz University of Medical Sceinces
City
Shiraz
Postal code
--
Approval date
2013-06-16, 1392/03/26
Ethics committee reference number
Ct-P-92-5713

Health conditions studied

1

Description of health condition studied
Major Depressive disorder
ICD-10 code
F30-ّ39
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Hamilton Derepssion Rating Scale
Timepoint
baseline, 2 week, and 6 week
Method of measurement
Interveiwe

Secondary outcomes

empty

Intervention groups

1

Description
Citalopram 20mg/day+Aspirin (160mg/day) for 6 weeks
Category
Treatment - Drugs

2

Description
Citalopram 20mg/day+Placebo for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Ghanizadeh
Street address
Hafez Hospital
City
Shiraz

2

Recruitment center
Name of recruitment center
Fasa University of Medical sciences
Full name of responsible person
Street address
City
Fasa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
Professor of Psychiatry
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71 1235 7282
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
Professor of Psychiatry
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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