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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.

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2018/027
Enrollment
Unknown
Registered
2018-08-15
Start date
2018-08-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

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. Blo

Sponsors

Faculty of Medicine, University of Kelaniya
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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]

Countries

Sri Lanka

Contacts

Public ContactDr. Asiri Rodrigo

lecturer and consultant psychiatrist

asirir2000@yahoo.comTel: 0112961115

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026