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.
- Conditions
- Depression
- Registration Number
- SLCTR/2018/027
- Lead Sponsor
- Faculty of Medicine, University of Kelaniya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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]<br>
- Secondary Outcome Measures
Name Time Method A change in the Global Assessment of Functioning scale<br><br>Side effects to celecoxib. <br>A check list will be used for assessing the side effects<br><br>Treatment compliance. <br> [On a monthly basis for 6 months from the start of the intervention]<br>