Home » Trials » SLCTR/2018/027


Celecoxib as adjunctive therapy in depression: a double- blind, randomized controlled trial -

SLCTR Registration Number

SLCTR/2018/027


Date of Registration

15 Aug 2018

The date of last modification

Aug 15, 2018



Application Summary


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 of Health Condition(s) Studied

Depression


Scientific Acronym

None


Public Acronym

None


Brief title

Celecoxib as adjunctive therapy in depression


Universal Trail 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)


Trial Details


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


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

  1. Males and females above 18 years
  2. Diagnosis of a depressive episode made by a consultant psychiatrist according to ICD-10 criteria
  3. Hamilton Depression Rating Scale score (HDRS) > 14 for the current episode

Exclusion criteria

  1. Previous diagnosis of Bipolar Affective Disorder, Schizophrenia or Schizoaffective disorder
  2. Depression due to chronic medical illnesses
  3. Organic brain disease
  4. Dependent on alcohol and other psychoactive substances
  5. Associated psychotic symptoms, strong suicidal ideas
  6. Undergone ECT during last 2 months
  7. Use of psychological treatment for the current episode
  8. Use of more than one antidepressant, mood stabilisers or antipsychotic medication for current episode
  9. Use of a higher dose of antidepressants than that recommended by British National Formulary (BNF) for the current episode.
  10. Ischemic Heart Disease, Stroke and Gastro intestinal bleeding due to Peptic Ulcers
  11. Pregnancy and Lactation
  12. Unable to give informed consent


Primary outcome(s)

A difference in total score of Hamilton Depression Rating Scale between the two groups


Primary outcome(s) - Time of assessment(s)

On a monthly basis for 6 months from the start of the intervention


Secondary outcome

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.


Secondary outcome(s) - Time of assessment(s)

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.



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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Kelaniya on 10th January 2017 (Ref. No. P/178/11/2016) Extension Date :18th April 2017


Funding source

None (Investigator funded)



Contact & Sponsor Information


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/

Secondary study sponsor (If any)

None