The purpose of the present investigation is to assess the efficacy of celecoxib in the treatment of mild to moderate among patients with brucellosis in a eight-week double-blind, placebo controlled trial. 50 adult outpatients who meet the DSM-V criteria for major depression(mild to moderate) will participate in the trial. Patients who have a baseline Hamilton Rating Scale for Depression score below 20 will be randomly allocated into two groups. 25 persons will receive Cap. rifampin (600 to 900 mg/day)+ Doxycycline100 mg bid+ cap. celecoxib 200 mg bid for 8 weeks. 25 patients will receive Cap. rifampin (600 to 900 mg/day)+ Doxycycline100 mg bid+ placebo for 8 weeks. Patients will be assessed by a psychiatrist at baseline and after 2, 4 and 8 weeks after the medication started. Efficacy will be defined as the change from baseline to endpoint in score on Hamilton Rating Scale for Depression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405271556N59
Registration date:2014-05-29, 1393/03/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-29, 1393/03/08
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Celecoxib in the treatment of depression in patients with Brucellosis: a double blind randomized trial
Public title
celecoxib in the treatment of depressed patients with brucellosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Confirmation of brucellusis, 2age between 18 to 50 years old, 3- score lower than 20 in Hamilton Rating Scale for depression 4-Mild to moderate major depressive disorder based on DSM-V
Exclusion criteria: 1-duration of brucellosis more than 3 months, 2-presence of localized brucellosis(including endocarditis, osteomyelitis), 3-psychotic disorder, 4-receiving psychotropic medications, 5-receiving antidepressants during the last month 6-receiving antibiotics during the last month, 7-patients who are under treatment with immunosuppressives, 8-history of cardiovascular disease, 9-pregnancy, 10-nursing women, 11-any significant medical condition(including malignancy, HIV infection, autoimmune disease,renal failure,hepatic failure), 12- other infectious diseases
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2014-05-01, 1393/02/11
Ethics committee reference number
24320
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Major Depressive episode
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline and weeks 2-4-8 after beginig of treatment
Method of measurement
by Hamiltion Depression Rating Scale 17-Item
Secondary outcomes
empty
Intervention groups
1
Description
Capsule Rifampine(900 mg/day in individuals with 75 kg weight or more and 600 mg/day in individuals with weight less than 75 kg)+ Cap. Doxycycline(100 mg bid)+ cap. celecoxib(200 mg bid) for 8 weeks
Category
Treatment - Drugs
2
Description
Capsule Rifampine(900 mg/day in individuals with 75 kg weight or more and 600 mg/day in individuals with weight less than 75 kg)+ Cap. Doxycycline(100 mg bid)+ cap. placebo for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
South Kregar street, Roozbeh Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr masoud yunesian
Street address
Keshvarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar Street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Karegar street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)