Effect of Celecoxib in addition to standard therapy in adults with Major Depressive Disorder: A double-blind, randomized clinical trial -

Introduction: Major depressive disorder (MDD) is an important cause of disability and only about 50% of patients achieve remission with standard antidepressant treatment. There is evidence that inflammatory mechanisms mediate the development and progression of this disease. However, controversy remains about the use of anti-inflammatory drugs as a therapeutic option for MDD. Research Hypothesis: Patients with MDD who receive celecoxib plus standard therapy achieve a lower score in the Hamilton rating scale for depression (HRSD) when compared to placebo plus standard therapy. Methods: A total of 80 out-patients from the Mental Health Service of the Fundacion Santa Fe de Bogota, aged 20-40 years old, with a diagnosis of moderate or severe MDD without previous treatment in the last 6 months will be included. Patients will be randomized to Celecoxib or placebo with an allocation ratio of 1:1 using a web-based random number generator. The primary endpoint will be the difference between the pretest and posttest score of the HRSD, after 6 months of treatment. Feasibility: This trial is feasible and relevant to the theme, in spite of the difficulty to maintain adherence in a study with MDD. Anticipated Results: Decrease in HRSD is expected in both groups during follow-up, but it is expected to be larger in the celecoxib group. A more rapid decrease of HRSD scores is expected in the 1st weeks.