Trial PaperChronic PainDepressive DisordersAnxiety DisordersHeadache Disorders (Cluster & Migraine)Safety & Risk ManagementKetamine

Efficacy and safety of oral ketamine versus diclofenac to alleviate mild to moderate depression in chronic pain patients: A double-blind, randomized, controlled trial

This double-blind study (n=40) compared the efficacy and safety of oral ketamine and diclofenac as treatments of mild to moderate depression over a 6-week treatment period and found that ketamine resulted in significant reductions of depression scores above those achieved by diclofenac.

Authors

  • Jafarinia, M.
  • Afarideh, M.
  • Tafakhori, A.

Published

Journal of Affective Disorders
individual Study

Abstract

Background

Ketamine is a glutamate N-methyl-d-aspartate receptor antagonist capable of exerting antidepressive effects in single or repeated intravenous infusions. The objective of this study was to investigate the safety and the efficacy of oral ketamine vs. diclofenac monotherapy in reducing symptoms of mild to moderate depression among patients with chronic pain.

Methods

This study is a 6-week, randomized, double-blind, controlled, parallel-group trial with two intervention arms (ketamine, fixed daily dosage of 150 mg vs. diclofenac, fixed daily dosage of 150 mg). Twenty participants in each arm completed the trial program all of whom had two post-baseline measurements at week 3 and week 6. Reduction in depression symptoms was assessed using the Hamilton Depression Rating Scale (HDRS) and the hospital anxiety and depression subscale for depression (HADSDepression) scores at baseline and week 3 and week 6 post-intervention.

Results

Significantly lower HDRS scores were observed in the ketamine treatment group as early as 6 weeks post-intervention (P=0.008). By comparison, mean (±standard deviation) HADS depression subscale scores were significantly lower for individuals receiving ketamine compared to diclofenac for both post-baseline measures at week 3 (6.95±1.47 vs. 8.40±1.6, P=0.005) and week 6 (6.20±1.15 vs. 7.35±1.18, p=0.003).

Limitations

The limitations of the present study were its small sample size and the short-term follow-up period.

Conclusions

Oral ketamine appears to be a safe and effective option in improving depressive symptoms of patients with chronic pain with mild-to-moderate depression.

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Research Summary of 'Efficacy and safety of oral ketamine versus diclofenac to alleviate mild to moderate depression in chronic pain patients: A double-blind, randomized, controlled trial'

Introduction

Comorbid pain and depression commonly coexist and worsen outcomes for both conditions, increasing disability and economic burden. Recent research has focused on glutamatergic dysfunction in depression and on ketamine, an NMDA receptor antagonist, which has produced rapid but often short-lived antidepressant effects when given intravenously. Practical barriers to repeated IV administration and concerns about durability have stimulated interest in alternative routes of administration such as intranasal, sublingual and oral ketamine. Jafarinia and colleagues set out to evaluate whether a fixed daily oral dose of ketamine could safely and effectively reduce symptoms of mild-to-moderate depression in patients with chronic headache-related pain. The trial compared oral ketamine with oral diclofenac over six weeks in a randomised, double-blind, parallel-group design, aiming to assess depressive symptom change, response and remission rates, pain intensity, and adverse events in this population.

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Study Details

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