The sleep and circadian rhythm disruptions in schizophrenia are attributed to a decrease in nocturnal melatonin level which may worsen if treated with conventional sedative drugs. This study was planned to evaluate the effects of add-on ramelteon on sleep and circadian rhythm disturbances in schizophrenia. A randomized, rater-blinded clinical trial was conducted on 120 patients with schizophrenia. Patients were categorized into predominantly positive (PG) or negative (NG) symptoms depending on Positive and Negative Syndrome Scale (PANSS) scoring, and then they were randomized into control (haloperidol/risperidone) or test (add-on ramelteon) groups. After recruitment, baseline serum melatonin, serum AANAT, urinary melatonin and Pittsburgh Sleep Quality Index (PSQI) were evaluated. Patients were reassessed after 4 weeks of therapy with antipsychotics with or without ramelteon. A significantly greater increase in night-time melatonin level (PG: 10·19; 95%CI: 1·42 to 18·97; p = 0·024; NG: 18·74; 95%CI: 8·48 to 29·0; p = 0·001), decrease in PSQI scores (PG: -1·57; 95%CI: -2·59 to -0·55; p = 0·003; NG: -2·49; 95%CI: -4·59 to -0·39; p = 0·021), increase in urinary melatonin (PG: 0·20; 95% CI: 0·056 to 0·35; p = 0·008; NG :0·15; 95% CI: 0·01 to 0·29; p = 0·034), increase in serum AANAT (PG: 4·61; 95%CI: 1·34 to 7·87; p = 0·007; NG:3·46; 95%CI: 1·30 to 5·63; p = 0·002) and improvement in PANSS score were found in patients receiving add-on ramelteon. The increase in serum melatonin and decrease in PSQI score were greater with predominantly negative symptom group in comparison to positive symptom group. Ramelteon may be considered as an add-on therapy with antipsychotic drugs for sleep and circadian rhythm disturbances in schizophrenia.

中文翻译：

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附加雷美替安疗法对精神分裂症患者睡眠和昼夜节律紊乱的影响：一项随机对照试验

精神分裂症的睡眠和昼夜节律紊乱归因于夜间褪黑激素水平的降低，如果用常规镇静药物治疗，这种情况可能会恶化。本研究旨在评估添加 ramelteon 对精神分裂症睡眠和昼夜节律紊乱的影响。对 120 名精神分裂症患者进行了一项随机、评估者盲法的临床试验。根据阳性和阴性症状量表 (PANSS) 评分将患者分为显着阳性 (PG) 或阴性 (NG) 症状，然后将他们随机分为对照组（氟哌啶醇/利培酮）或测试组（添加 ramelteon）。招募后，评估基线血清褪黑激素、血清 AANAT、尿褪黑激素和匹兹堡睡眠质量指数 (PSQI)。患者在接受抗精神病药治疗 4 周后重新评估，加或不加雷美替安。夜间褪黑激素水平显着增加（PG：10·19；95%CI：1·42 至 18·97；p = 0·024；NG：18·74；95%CI：8·48 至 29 ·0；p = 0·001），PSQI 分数降低（PG：-1·57；95%CI：-2·59 至 -0·55；p = 0·003；NG：-2·49；95 %CI：-4·59 到 -0·39；p = 0·021），尿褪黑激素增加（PG：0·20；95% CI：0·056 到 0·35；p = 0·008；NG :0·15；95% CI：0·01 到 0·29；p = 0·034)，血清 AANAT 增加（PG：4·61；95% CI：1·34 到 7·87；p = 0 ·007；NG：3·46；95%CI：1·30 至 5·63；p = 0·002）和 PANSS 评分在接受附加雷美替恩的患者中有所改善。与阳性症状组相比，主要阴性症状组血清褪黑激素的增加和 PSQI 评分的降低更大。