A randomized, double-blind, placebo-controlled trial of pentoxifylline augmentation of sertraline in treatment of drug-naive depressed women: a pilot study.

Negar Mirzai,1 Farshad hashemian,2,* Maryam vahdat shariatpanahi,3 Mohammad reza seddigh,4

1. Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran
2. Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran
3. Department of Psychiatry, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran
4. Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran

Abstract

Introduction

Depression is among the most common, non-fatal diseases nowadays. growing evidences suggests that immune system and its function’s alteration could play a key role in pathophysiology of affective disorders especially depression. many investigations have shown that probably serum level of tnf-α and il-6 have risen in major depressive disorder. on the other hand, pentoxifylline in animal models has shown anti-depressant like effects through decreasing cytokines level in serum.

Methods

This pilot study is a randomized, double-blind, placebo-controlled trial. 11 mdd patients with hamilton depression rating scale (ham-d) ≥ 18 were randomly designated as treatment and control group (the former treated with ptx 400 mg twice daily and the latter one treated with placebo bd in addition to sertraline 50 mg/day during 8 weeks). patients were evaluated by ham-d scores at baseline and week 8, also serum level of il-6 and tnf-α were measured at baseline and 8 weeks after treatment.

Results

No significant correlation was observed in alteration of tnf-α, il-6 serum level and ham-d scores between both groups, during 8 weeks of treatment. tnf-α level increased in both groups, however not significantly (baseline to week 8) (p=.24, .68). serum level of il-6 rose after 8 weeks in ptx-treated patients, and this reversed in placebo-treated group, the overall change was not significant (p= .34, .13).

Conclusion

Our study does not show any significant anti-depressant effects of pentoxifylline, however to elucidate probable anti-depressant effect of ptx we need more studies with larger sample size.

Keywords

Interleukin-6, tnf-α, pentoxifylline, major depressive disorder