According to DSM IV, participant with the diagnosis of Major Depression whose score of deppression according to Hamilton Depression Scale (HamD) would not be more than 22 will be included. Psychotic disorders and other diagnosis would be excluded. They should not be on antipsychotic or antidepressant (during the last month) drugs. In addition, they should not receive ECT. Patients have to be free of thyroid disease and they should be between 18-50 years old. They have to be free from cardiovascular disorders and ECG will be taken from those who suspicious to heart disease. Pregnant ladies and breast feeding mothers would be excluded from the study. Informed consent will be taken from all of the participants. Participants will divided into two groups. First group will receive Serteralin (200 mg/d) + Celexibe (200 mg BID) for 6 weeks. Second group will receive Serteralin (200 mg/d) + Placebo for 6 weeks. Then Patients will be followed at 0, 2, 4, and 6 months intervals according to the Hamilton Depression Scale (Ham D). Final results will be added to the same research which is running at Tehran University of Medical Sciences and analysis will be done then.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903124090N1
Registration date:2010-09-01, 1389/06/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-01, 1389/06/10
Registrant information
Name
Seyed Hesameddin Abbasi
Name of organization / entity
Tehran Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9720
Email address
abbasi@tehranheartcenter.org
Recruitment status
Recruitment complete
Funding source
National Iranian Oil Company Health Organization
Expected recruitment start date
2010-06-15, 1389/03/25
Expected recruitment end date
2010-09-15, 1389/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double-blind placebo controlled trial of celecoxibe added to sertralin in patients with moderate to severe depression
Public title
Effect of celecoxibe added to sertralin in patients with moderate to severe depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1. Major Depression according to DSM IV and Hamilton Depression Scale(HamD)
2. 18 y < age > 50 y
Exclusion Criteria:
1. Having psychotic disorders
2. Receiving anti-depressant drugs during last month
3. Receiving ECT during last two months
4. Having thyroid disorder
5. Having Cardiovascular disorders
6. Pregnancy
7. Breast Feeding
8. Age <18 y
9. Age > 50 y
Age
From 18 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Tehran University of Medical Sciences
Street address
Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2017-02-21, 1395/12/03
Ethics committee reference number
5402
Health conditions studied
1
Description of health condition studied
Major Depression
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
Depression
Timepoint
0, 2, 4, 6 weeks intervals
Method of measurement
Hamilton depression scale
Secondary outcomes
1
Description
Antidepressants and Celxocibe side effects
Timepoint
0, 2, 4 and 6 weeks intervals
Method of measurement
drug side effects check list
Intervention groups
1
Description
Case group will receive Serteralin (200 mg/d) + Celexibe (200 mg BID) for 6 weeks.
Category
Placebo
2
Description
Control group will receive Serteralin (200 mg/d) + Placebo for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
NIOC Central Hospital and Roozbeh Hospital
Full name of responsible person
Professor Shahin Akhondzadeh
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Iranian Oil Company Health Organization
Full name of responsible person
Dr. Farzaneh Torkan
Street address
Hafez Street, Sakhaee Street, NIOC Central Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Iranian Oil Company Health Organization
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
Tehran University of Medical Sciences
Full name of responsible person
Professor Shahin Akhondzadeh
Position
Profressor of Neurosciences, Vice Dean of School of Medicine
Other areas of specialty/work
Street address
School of Medicine, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 912 171 1045
Fax
Email
s.akhond@neda.net
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Professor Shahin Akhondzadeh
Position
Profressor of Neurosciences, Vice Dean of School of Medicine
Other areas of specialty/work
Street address
School of Medicine, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 912 171 1045
Fax
Email
s.akhond@neda.net
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr. Seyed Hesameddin Abbasi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)