Palmitoylethanolamide as adjunctive therapy in major depressive disorder: A double-blind, randomized and placebo-controlled trial.

摘要: Abstract Background Experimental studies provide evidence for antidepressant effects of Palmitoylethanolamide (PEA) in animal models depression. We aimed to evaluate the efficacy and tolerability PEA add-on therapy treatment patients with major depressive disorder (MDD). Methods In a randomized double-blind, placebo-controlled study, 58 MDD (DSM-5) Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were receive either 600 mg twice daily or placebo addition citalopram six weeks. Patients assessed using HAM-D scale at baseline weeks 2, 4, 6. Results Fifty-four individuals completed trial. At week group demonstrated significantly greater reduction scores compared (8.30 ± 2.41 vs. 5.81 3.57, P = .004). The also improvement symptoms [F (3, 156) 3.35, .021] throughout trial period. experienced more response rate (≥ 50% score) than (100% 74% respectively, .01) end Baseline parameters frequency side not different between two groups. Limitations population size this study was small follow-up period relatively short. Conclusions adjunctive can effectively improve (predominantly male gender) disorder. showed rapid-onset which need further investigation.