Abedini Talieh, Hosseyni Reyhaneh, Ghannadi Farnaz, Moghaddam Hossein Sanjari, Ardakani Mohammad-Reza Khodaei, Talaei Ali, Akhondzadeh Shahin
Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Department of Psychiatry, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
Psychiatry Clin Neurosci. 2022 Oct;76(10):505-511. doi: 10.1111/pcn.13441. Epub 2022 Jul 19.
Palmitoylethanolamide is an endogenous fatty acid amide with neuroprotective and anti-inflammatory actions. We performed a randomized, double-blind, placebo-controlled clinical trial to investigate the efficacy and safety of palmitoylethanolamide combination therapy in acute mania.
Patients in the acute phase of mania were assigned into two parallel groups given either lithium (blood level of 0.8-1.1 mEq/L) and risperidone 3 mg plus palmitoylethanolamide 600 mg or placebo twice per day for 6 weeks. All participants were assessed with the Young Mania Rating Scale (YMRS), Hamilton Depression Rating Scale (HDRS), and Extrapyramidal Symptom Rating Scale (ESRS) at baseline and at weeks 1, 2, 4, and 6.
A total of 63 patients (32 in palmitoylethanolamide and 31 in placebo groups) completed the trial. We found a significant effect for time×treatment interaction on the YMRS score (F = 5.22, d.f. = 2.34, P= 0.004) from baseline to study end point. Results from independent t test showed a significantly greater decrease in YMRS scores in the palmitoylethanolamide group, compared with the placebo group, from baseline to weeks 4 and 6 (P= 0.018 and P= 0.002, respectively). There was no significant difference between palmitoylethanolamide and placebo groups based on ESRS scores or ESRS changes in scores (P>0.05).
Our findings provide preliminary evidence that palmitoylethanolamide is an effective adjunctive medication that improves manic symptoms and overall clinical status in acute episodes of mania. However, larger sample sizes and more extended follow-up therapy are needed in future studies to confirm our findings.
棕榈酰乙醇胺是一种具有神经保护和抗炎作用的内源性脂肪酸酰胺。我们进行了一项随机、双盲、安慰剂对照临床试验，以研究棕榈酰乙醇胺联合疗法在急性躁狂症中的疗效和安全性。
将躁狂症急性期患者分为两个平行组，一组给予锂盐（血药浓度为0.8 - 1.1 mEq/L）、3 mg利培酮加600 mg棕榈酰乙醇胺，另一组给予安慰剂，均每日两次，持续6周。在基线以及第1、2、4和6周时，使用杨氏躁狂评定量表（YMRS）、汉密尔顿抑郁评定量表（HDRS）和锥体外系症状评定量表（ESRS）对所有参与者进行评估。
共有63名患者（棕榈酰乙醇胺组32名，安慰剂组31名）完成了试验。我们发现从基线到研究终点，时间×治疗交互作用对YMRS评分有显著影响（F = 5.22，自由度 = 2.34，P = 0.004）。独立t检验结果显示，从基线到第4周和第6周，棕榈酰乙醇胺组的YMRS评分较安慰剂组显著下降更多（分别为P = 0.018和P = 0.002）。基于ESRS评分或ESRS评分变化，棕榈酰乙醇胺组与安慰剂组之间无显著差异（P>0.05）。
我们的研究结果提供了初步证据，表明棕榈酰乙醇胺是一种有效的辅助药物，可改善躁狂症急性发作时的躁狂症状和整体临床状况。然而，未来研究需要更大样本量和更长时间的随访治疗来证实我们的发现。
