Clinical trial of adjunctive celecoxib treatment in patients with major depression: a double blind and placebo controlled trial

Depress Anxiety. 2009;26(7):607-11. doi: 10.1002/da.20589.


Background: The pathophysiology of depression is associated with the hyperactivity of immune inflammatory responses. Cyclooxygenase-2 inhibitors such as celecoxib reduce the production of pro-inflammatory cytokines. The purpose of the present investigation was to assess the efficacy of celecoxib as an adjuvant agent in the treatment of major depression in a six-week double blind and placebo controlled trial.

Methods: Forty adult outpatients who met the DSM-IV-TR criteria for major depression participated in the trial. Patients have a baseline Hamilton Rating Scale for Depression score of at least 18. Patients were allocated in a random fashion: 20 to fluoxetine 40 mg/day plus celecoxib 400 mg/day (200 mg bid) (morning and evening) and 20 to fluoxetine 40 mg/day plus placebo. Patients were assessed by a psychiatrist at baseline and after 1, 2, 4, and 6 weeks after the medication started.

Results: Although both protocols significantly decreased the score of Hamilton Rating Scale for Depression over the trial period, the combination of fluoxetine and celecoxib showed a significant superiority over fluoxetine alone in the treatment of symptoms of major depression. There were no significant differences in the two groups in terms of observed side effects.

Conclusion: The results of this study suggest that celecoxib may be an effective adjuvant agent in the management of patients with major depression and anti-inflammatory therapies should be further investigated.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Celecoxib
  • Cyclooxygenase 2 Inhibitors / administration & dosage
  • Cyclooxygenase 2 Inhibitors / pharmacology*
  • Cyclooxygenase 2 Inhibitors / therapeutic use*
  • Depressive Disorder, Major / diagnosis
  • Depressive Disorder, Major / drug therapy*
  • Depressive Disorder, Major / physiopathology
  • Diagnostic and Statistical Manual of Mental Disorders
  • Dinoprostone / antagonists & inhibitors
  • Dinoprostone / biosynthesis
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Fluoxetine / administration & dosage
  • Fluoxetine / therapeutic use*
  • Humans
  • Interleukin-6 / antagonists & inhibitors
  • Interleukin-6 / biosynthesis
  • Male
  • Middle Aged
  • Prospective Studies
  • Pyrazoles / administration & dosage
  • Pyrazoles / pharmacology*
  • Pyrazoles / therapeutic use*
  • Serotonin Uptake Inhibitors / administration & dosage
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Severity of Illness Index
  • Sulfonamides / administration & dosage
  • Sulfonamides / pharmacology*
  • Sulfonamides / therapeutic use*
  • Surveys and Questionnaires
  • Young Adult


  • Cyclooxygenase 2 Inhibitors
  • Interleukin-6
  • Pyrazoles
  • Serotonin Uptake Inhibitors
  • Sulfonamides
  • Fluoxetine
  • Celecoxib
  • Dinoprostone