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Principles and Practice of Clinical Research - Study Design



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

Agnes Carvalho-Andrade, Christian Robles, Claudia Suemoto, Renato Arruda, Pedro Barbieri, Thais Cano, Fabio Carmona, Diana Castro-Villabón, Lucas Chaves Netto, Mariela Chinchihualpa, Jose Crespo, Denise Durand, Rishat A Gabidullin, Jorge Henrique Santos Leal, Alicia Londono, Gelia Ribeiro Nuñez, Irada D Nurasheva, Omidi Reza, Juliane de Melo Silva, Marie Jose Castañeda Vera, José Fernando Vera-Chamorro, Siraj O Wali.

Abstract
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 Bogotá, 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.

Key words: Celecoxib, depression, treatment



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