Home » Trials » SLCTR/2018/027
Celecoxib as adjunctive therapy in depression: a double- blind, randomized controlled trial
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SLCTR Registration Number
SLCTR/2018/027
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Celecoxib as adjunctive therapy in depression: a double- blind, randomized controlled trial
Public Title of Trial
A randomized controlled trial to evaluate the effectiveness of Celecoxib vs placebo as an additional treatment for depression in outpatients of Colombo North Teaching hospital Ragama.
Disease or Health Condition(s) Studied
Depression
Scientific Acronym
None
Public Acronym
None
Brief title
Celecoxib as adjunctive therapy in depression
Universal Trial Number
U1111-1213-0256
Any other number(s) assigned to the trial and issuing authority
P/178/11/2016 (Ethics Review Committee of Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Is celecoxib effective as an additional treatment for depression in outpatients of Colombo North Teaching hospital Ragama?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study setting:Outpatient psychiatric clinics at Colombo North Teaching Hospital Ragama
To randomize the patients in a 1:1 ratio (blocks of four), a computer random number generator will be used. Block randomization will be used.
The participant, treating psychiatrist, treating doctors, clinic staff, who assessed the patient and prescribed the drug, data collectors, outcome assessors and statistician will be blind to allocation.
Group 1 will receive 2 placebo capsules which is identical to Celecoxib to be taken once daily for 6 months (This is a matching capsule which contains ingredients identical to celecoxib except for the active ingredient).
Group 2 will be treated with Celecoxib 400mg per a day for 6 months (2 capsules of 200 mg each) . . Existing antidepressants and other treatment such as benzodiazepine will be continued according to clinical needs.
Patients in both groups will be reviewed at the clinic by treating doctors at least monthly. If required they would be seen more frequently depending on their clinical needs.
Their treatment would be changed, including commencing them on antipsychotic medications and mood stabilizers, considering inpatient management and ECT as per their clinical state
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
A difference in total score of Hamilton Depression Rating Scale between the two groups |
[ On a monthly basis for 6 months from the start of the intervention ] |
Secondary outcome(s)
|
1.
A change in the Global Assessment of Functioning scale Side effects to celecoxib. A check list will be used for assessing the side effects Treatment compliance. |
[ On a monthly basis for 6 months from the start of the intervention ] |
Target number/sample size
120(60 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2018-08-15
Anticipated end date
2018-11-08
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-01-19
Approval number
P/178/11/2016 (Extended from 10.01.2018)
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Asiri Rodrigo
lecturer and consultant psychiatrist
Department of Psychiatry
Faculty of Medicine
University of Kelaniya
Sri Lanka
Tel: 0112961115
Mob: 0777865791
Fax: 0112958837
asirir2000@yahoo.com
Contact Person for Public Queries
Thamali Dissanayake
Speech and Language therapist
Faculty of Medicine
University of Kelaniya
Ragama
Sri Lanka
Mob: 0717954890
thamalidissanayake@gmail.com
Primary study sponsor/organization
Faculty of Medicine, University of Kelaniya
P.O Box 6
Thalagolla Road
Ragama
Sri Lanka
Tel: 0112961115
Fax: 0112958837
info.med@kln.ac.lk
http://medicine.kln.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Applicable
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
