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Palmitoylethanolamide As Adjunctive Therapy in Major Depressive Disorder: A Double-Blind, Randomized and Placebo-Controlled Trial Publisher Pubmed



Ghazizadehhashemi M1 ; Ghajar A2 ; Shalbafan MR1 ; Ghazizadehhashemi F1 ; Afarideh M2 ; Malekpour F1 ; Ghaleiha A3 ; Ardebili ME1 ; Akhondzadeh S2
Authors

Source: Journal of Affective Disorders Published:2018


Abstract

Background: Experimental studies provide evidence for antidepressant effects of Palmitoylethanolamide (PEA) in animal models of depression. We aimed to evaluate the efficacy and tolerability of PEA add-on therapy in treatment of patients with major depressive disorder (MDD). Methods: In a randomized double-blind, and placebo-controlled study, 58 patients with MDD (DSM-5) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were randomized to receive either 600 mg twice daily Palmitoylethanolamide or placebo in addition to citalopram for six weeks. Patients were assessed using the HAM-D scale at baseline and weeks 2, 4, and 6. Results: Fifty-four individuals completed the trial. At week 2, patients in the PEA group demonstrated significantly greater reduction in HAM-D scores compared to the placebo group (8.30 ± 2.41 vs. 5.81 ± 3.57, P =.004). The PEA group also demonstrated significantly greater improvement in depressive symptoms [F (3, 156) = 3.35, P =.021] compared to the placebo group throughout the trial period. The patients in the PEA group experienced more response rate (≥ 50% reduction in the HAM-D score) than the placebo group (100% vs. 74% respectively, P =.01) at the end of the trial. Baseline parameters and frequency of side effects were not significantly different between the two groups. Limitations: The population size in this study was small and the follow-up period was relatively short. Conclusions: Palmitoylethanolamide adjunctive therapy to citalopram can effectively improve symptoms of patients (predominantly male gender) with major depressive disorder. PEA showed rapid-onset antidepressant effects which need further investigation. © 2018 Elsevier B.V.
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