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Table 1 Objectives and hypotheses of the study. Table stating study objectives and hypothesis in a generic way and in a drug-specific way

From: Anti-inflammatory treatment of depression: study protocol for a randomised controlled trial of vortioxetine augmented with celecoxib or placebo

  Generic way Drug-specific way
Primary objective To investigate the antidepressant efficacy of the 6-week combined treatment of MDD with antidepressant plus anti-inflammatory To investigate the antidepressant efficacy of the 6-week combined treatment of MDD with vortioxetine plus celecoxib 400 mg
Primary hypothesis A higher efficacy and larger reduction in symptoms of depression will be observed after 6 weeks when treatment is combined (antidepressant and anti-inflammatory) in individuals with baseline inflammation A higher efficacy and larger reduction in symptoms of depression will be observed after 6 weeks when treatment is combined (vortioxetine and celecoxib 400 mg) in individuals with baseline inflammation
Secondary objective 1 To investigate the anti-inflammatory effects of a combined treatment of MDD with antidepressant and anti-inflammatory in individuals with baseline inflammation (CRP levels > 3 mg/L) over a 6-week period To investigate the anti-inflammatory effects of a combined treatment of MDD with vortioxetine and celecoxib 400 mg in individuals with baseline inflammation (CRP levels > 3 mg/L) over a 6-week period
Secondary hypothesis A larger reduction of circulating levels of the inflammatory marker CRP will be observed in the group of depressed patients who are treated with antidepressant plus anti-inflammatory medication A larger reduction of circulating levels of the inflammatory marker CRP will be observed in the group of depressed patients who are treated with vortioxetine plus celecoxib 400 mg
Secondary objective 2 To test whether there is evidence of a different effect of the combined treatment in the two inflammation strata To test whether there is evidence of a different effect of the combined treatment with vortioxetine and celecoxib 400 mg in the two inflammation strata
Secondary objective 3 To investigate the safety of the anti-inflammatory treatment when combined with antidepressant To investigate the safety celecoxib 400 mg treatment when combined with vortioxetine
Secondary objective 4 To investigate the effects of the antidepressant on cognition, psychosocial and workplace performance measures in MDD To investigate the effects of vortioxetine on cognition, psychosocial and workplace performance measures in MDD