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

Ghazizadeh-Hashemi, M. and Ghajar, A. and Shalbafan, M.-R. and Ghazizadeh-Hashemi, F. and Afarideh, M. and Malekpour, F. and Ghaleiha, A. and Ardebili, M.E. and Akhondzadeh, S. (2018) Palmitoylethanolamide as adjunctive therapy in major depressive disorder: A double-blind, randomized and placebo-controlled trial. Journal of Affective Disorders, 232. pp. 127-133.

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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.

Item Type: Article
Additional Information: cited By 1
Uncontrolled Keywords: citalopram; palmidrol; placebo; antidepressant agent; citalopram; ethanolamine derivative; nonsteroid antiinflammatory agent; palmidrol; palmitic acid derivative, add on therapy; adult; adverse outcome; Article; blurred vision; controlled study; diarrhea; dizziness; double blind procedure; drowsiness; drug efficacy; drug tolerability; DSM-5; female; follow up; Hamilton Depression Rating Scale; human; increased appetite; loss of appetite; major clinical study; major depression; male; movement (physiology); nervousness; patient assessment; priority journal; randomized controlled trial; rash; restlessness; side effect; sore throat; study design; tachycardia; tremor; xerostomia; adjuvant chemotherapy; clinical trial; combination drug therapy; major depression; multicenter study; pathophysiology; treatment outcome, Adult; Anti-Inflammatory Agents, Non-Steroidal; Antidepressive Agents; Chemotherapy, Adjuvant; Citalopram; Depressive Disorder, Major; Double-Blind Method; Drug Therapy, Combination; Ethanolamines; Female; Humans; Male; Palmitic Acids; Treatment Outcome
Subjects: WM Psychiatry
Depositing User: eprints admin
Date Deposited: 29 Dec 2018 11:16
Last Modified: 21 Aug 2019 08:38

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