Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical, Sciences, Tehran, Iran.
Department of Psychiatry, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
Psychiatry Res. 2022 Oct;316:114737. doi: 10.1016/j.psychres.2022.114737. Epub 2022 Jul 27.
Primary negative symptoms of schizophrenia are usually resistant to monotherapy with antipsychotics. The present study sought to assess the efficacy and tolerability of Palmitoylethanolamide (PEA) adjunctive therapy in treatment of negative symptoms in patients with stable schizophrenia.
This 8-week (trial timepoints: baseline, week 4, week 8), double-blind, placebo-controlled clinical trial randomized patients with schizophrenia in a 1:1 ratio to compare the efficacy and safety of 600 mg twice a day of PEA and matched placebo alongside a stable dose of risperidone. Outcome measures were the positive and the negative syndrome scale (PANSS), the extrapyramidal symptom rating scale (ESRS), and the Hamilton depression rating scale (HDRS). The primary outcome was change in the negative subscale score during the trial period between the groups. Safety of interventions were controlled and addressed during the trial.
A total of 50 participants completed the trial (25 in each group). Baseline characteristics of the groups were comparable (p>0.05). There was significant effect from time-treatment interaction on negative symptoms (p = 0.012) suggesting greater symptom improvement in the PEA group. In contrast, the longitudinal changes in positive symptoms and depressive symptoms were similar between groups (p values>0.05). Safety assessments showed no significant difference regarding extrapyramidal symptoms, measured by ESRS, and also frequency of other complications between PEA and placebo groups (p values>0.05).
Adjunctive therapy with PEA and risperidone alleviates schizophrenia-related primary negative symptoms in a safe manner.
精神分裂症的主要阴性症状通常对抗精神病药物的单一疗法具有抗性。本研究旨在评估棕榈酸乙醇酰胺（PEA）辅助治疗对稳定精神分裂症患者阴性症状的疗效和耐受性。
这是一项为期 8 周的（试验时间点：基线、第 4 周、第 8 周）、双盲、安慰剂对照临床试验，将精神分裂症患者以 1:1 的比例随机分组，比较每天两次 600mg PEA 和匹配安慰剂与稳定剂量利培酮联合治疗的疗效和安全性。结局指标为阳性和阴性症状量表（PANSS）、锥体外系症状评定量表（ESRS）和汉密尔顿抑郁量表（HDRS）。主要结局是试验期间两组之间阴性量表评分的变化。在试验过程中控制和解决了干预措施的安全性问题。
共有 50 名参与者完成了试验（每组 25 名）。两组的基线特征相当（p>0.05）。时间-治疗交互作用对阴性症状有显著影响（p=0.012），提示 PEA 组症状改善更明显。相比之下，阳性症状和抑郁症状的纵向变化在两组之间相似（p 值>0.05）。安全性评估显示，PEA 和安慰剂组在 ESRS 测量的锥体外系症状以及其他并发症的发生率方面没有显著差异（p 值>0.05）。
PEA 与利培酮联合辅助治疗以安全的方式缓解与精神分裂症相关的原发性阴性症状。
