The present study was designed to evaluate the therapeutic effect of COX-2 inhibitor Celecoxib (200 mg/day) as an augmentation therapy in the treatment of drug naïve depressed women. All patients (n=40) were women experiencing first episode of depression according to DSM-IV-TR. None of them had previously received antidepressant treatment and the Hamilton rating scale (17 items) score was ranged from 18 to 36. Patients with history of taking antidepressant medications, other psychiatric disorders, significant suicidal ideation, Liver and kidney dysfunction and cardiovascular disorders were excluded. Patients randomly received 25-100 mg/day Sertraline plus 100mg Celecoxib or placebo twice daily. Participants were assessed by Hamilton depression and anxiety rating scale and general health questionnaire at baseline, 4 and 8 weeks of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009043106N3
Registration date:2010-11-14, 1389/08/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-14, 1389/08/23
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Sciences Branch of Islamic Azad University & Personal resources
Expected recruitment start date
2008-07-22, 1387/05/01
Expected recruitment end date
2010-06-20, 1389/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized, Double-blind, Placebo-controlled trial of Celecoxib augmentation of Sertraline in treatment of Drug-Naïve depressed women
Public title
Celecoxib add on therapy in drug naive depressed women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. women experiencing first episode of depression according to DSM-IV-TR and the Hamilton rating scale (17 items) score was ranged from 18 to 36. 2. None of them had previously received antidepressant treatment. Exclusion criteria: 1. History of taking antidepressant medications. 2. Other psychiatric disorders. 3. Significant suicidal ideation. 4. lactation and pregnancy. 5. Liver and kidney dysfunction and cardiovascular disorders. 6. Drug abuse.
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Pharmaceutical sciences branch of Islamic Azad university
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Approval date
2010-11-04, 1389/08/13
Ethics committee reference number
4114
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 severity
Timepoint
baseline, week 4 and week 8
Method of measurement
Hamilton Depression rating scale -17 items
2
Description
anxiety severity
Timepoint
baseline, week 4 and week 8
Method of measurement
Hamilton Anxiety rating scale
Secondary outcomes
1
Description
general health level
Timepoint
baseline, week 4 and week 8
Method of measurement
General health questionnair-28
Intervention groups
1
Description
Celecoxib group: 25-100mg/day Sertraline plus 100mg Celecoxib twice daily for eight weeks.
Category
Treatment - Drugs
2
Description
Control group: 25-100mg/day Sertraline plus 100mg placebo twice daily for eight weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zafar clinic
Full name of responsible person
Dr. Ali Sharifi
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Dr.Seyed Mohammad Hossini
Street address
City
Hamedan
3
Recruitment center
Name of recruitment center
Shahid Lavasani hospital
Full name of responsible person
Dr. Maryam Vahdat Shariat-panahi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical Sciences Branch of Islamic Azad university
Full name of responsible person
Dr. Orkideh G. Dadras
Street address
Shariatee Ave. Yakhchal Str.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Sciences Branch of Islamic Azad university
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical sciences branch of Islamic Azad university
Full name of responsible person
Dr. Farshad Hashemian
Position
assistant professor/clinical pharmacist
Other areas of specialty/work
Street address
No.99, Yakhchal strteet, Dr. Shariati Avenue
City
Tehran
Postal code
Phone
+98 21 2260 0037
Fax
+98 21 8857 7961
Email
hashemian.f@iaups.ac.ir , fhashemian@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)