Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Department of Psychiatry, Razi Hospital, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
Psychopharmacology (Berl). 2023 Dec;240(12):2631-2640. doi: 10.1007/s00213-023-06458-9. Epub 2023 Sep 12.
Inadequate responses to current schizophrenia treatments have accelerated research into novel therapeutic approaches.
This study investigated the efficacy and tolerability of adjunctive L-theanine, an ingredient with neuroimmunomodulatory and neuroprotective properties, for chronic schizophrenia.
Eighty chronic schizophrenia inpatients were equally assigned to receive risperidone (6 mg/day) plus either L-theanine (400 mg/day) or matched placebo in this 8-week, randomized, parallel-group, double-blind, placebo-controlled trial. The participants were assessed using the Positive and Negative Syndrome Scale (PANSS) by recording the results of subscales at baseline and weeks 4 and 8 to measure treatment efficacy. Additionally, the participants were assessed for the Hamilton Depression Rating Scale (HDRS) and adverse events, including the Extrapyramidal Symptom Rating Scale (ESRS).
Sixty patients, 30 in each group, were included in the analyses. All baseline demographic and clinical characteristics were comparable between the groups (p-values > 0.05). The reduction rates from baseline to endpoint in negative, general psychopathology, and total scores of PANSS were greater in the L-theanine group (p-values = 0.03, 0.01, and 0.04, respectively). Regarding general psychopathology scores, the reduction in the L-theanine group was also greater until week 4 (p-value < 0.01). The time × treatment interaction effect was significant on negative (p-value = 0.03), general psychopathology (p-value < 0.01), and total (p-value = 0.04) scores of PANSS, indicating additional improvements in the L-theanine group. The HDRS and side effects were comparable between the groups (p-values > 0.05).
L-Theanine adjunct to risperidone safely and tolerably outperformed adjunctive placebo for schizophrenia, and promising evidence indicated its effects on primary negative symptoms, which need to be scrutinized in further studies.
The study protocol was registered and published prospectively in the Iranian Registry of Clinical Trials ( http://www.irct.ir ; registration number: IRCT20090117001556N133) on 2020-12-12.
当前精神分裂症治疗效果不佳，这加速了新型治疗方法的研究。
本研究旨在探讨辅助性 L-茶氨酸（一种具有神经免疫调节和神经保护作用的成分）对慢性精神分裂症的疗效和耐受性。
80 例慢性精神分裂症住院患者被随机分为两组，每组 40 人，分别接受利培酮（6 mg/天）加 L-茶氨酸（400 mg/天）或匹配的安慰剂治疗，疗程 8 周。采用阳性和阴性综合征量表（PANSS）评估疗效，记录基线和第 4、8 周的各分量表评分。同时评估汉密尔顿抑郁量表（HDRS）和不良反应，包括锥体外系症状评定量表（ESRS）。
60 例患者（每组 30 例）纳入分析。两组患者的基线人口统计学和临床特征均无统计学差异（p 值均>0.05）。L-茶氨酸组的阴性症状、一般精神病性症状和 PANSS 总分的减分率从基线到终点均显著大于安慰剂组（p 值分别为 0.03、0.01 和 0.04）。在一般精神病性症状评分方面，L-茶氨酸组的减分也在第 4 周更为显著（p 值<0.01）。阴性（p 值=0.03）、一般精神病性（p 值<0.01）和总分（p 值=0.04）PANSS 评分的时间与治疗的交互作用有统计学意义，表明 L-茶氨酸组有额外的改善。两组患者的 HDRS 和不良反应评分无统计学差异（p 值均>0.05）。
与安慰剂相比，L-茶氨酸辅助利培酮治疗精神分裂症更安全、耐受性更好，其对主要阴性症状的疗效有一定的提示作用，需要进一步研究证实。
本研究方案于 2020 年 12 月 12 日在伊朗临床试验注册中心（http://www.irct.ir；注册号：IRCT20090117001556N133）进行了注册和前瞻性发表。
