The purpose of the present investigation is to assess the efficacy of celecoxib in the treatment of mild to moderate among patients with colon cancer receiving chemotherapy in a six-week double-blind, placebo controlled trial. 40 adult outpatients who meet the DSM-5 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. 20 persons will receive celecoxib 200 mg BID and 20 participants will receive placebo. Patients were assessed by a psychiatrist at baseline and after 2,4 and 6 weeks after the medication started. Efficacy will be defined as the change from baseline to endpoint in score on Hamilton Rating Scale for Depression. Severity of pain will be assessed by Visual Analogue Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508201556N79
Registration date:2015-08-23, 1394/06/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-23, 1394/06/01
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
2015-08-23, 1394/06/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
celecoxib in the treatment of mild to moderate depression in patients with colon cancer: A randomized placebo controlled trial
Public title
Antidepressant effects of Celecoxib in the treatment of patients with colon cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Confirmation of colon cancer;2-receiving chemotherapy 3- score lower than 20 in Hamilton Rating Scale for depression 4-Mild to moderate major depressive disorder based on DSM-5
Exclusin criteria: 1-psychosis or other psychiatric disorder 2-Receiving psychotropic medications,3- receiving any antidepressants during past one month or ECT during past two months 4-history of cardiovascular disease , 5-pregnancy or breast feeding, 6-thyroid diseases
Age
From 18 years old to 65 years old
Gender
Both
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshvarz Blvd
City
Tehran
Postal code
Approval date
2015-08-06, 1394/05/15
Ethics committee reference number
IR.TUMS.REC.1394.568
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 2-4-6 after beginig of treatment
Method of measurement
by Hamiltion Depression Rating Scale 17-Item
Secondary outcomes
1
Description
severity of pain
Timepoint
Baseline and weeks 2-4-6 after beginig of treatment
Method of measurement
by Visual Analogue Scale
Intervention groups
1
Description
Capsule Celecoxib200 mg BID as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Cap. placebo as control group for 6 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
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
Tehran University of Medical Sciences, 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 Kargar 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)