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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
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Authors Affiliations
  1. 1. Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran
  2. 2. Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences, Hamadan, Iran

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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