2/2-Antipsychotic Effects of Oxytocin

描述（申请人提供）：肽神经激素，催产素在调节多种中枢神经系统功能中起关键作用，与精神分裂症高度相关。几项使用精神病动物模型的研究表明，催产素具有抗精神病样作用。最近的一项小型概念验证研究发现，与服用安慰剂的患者相比，服用鼻内催产素（40iu BID）作为现有抗精神病药物的辅助治疗3周，精神分裂症患者的精神病症状明显减轻，记忆力得到改善。我们现在建议进行一项后续研究，增加更高的剂量，延长治疗时间，目的是复制和扩大有希望的初步发现。具体而言，拟议的研究将测试6周每日鼻内催产素（40iu BID或80iu BID）与安慰剂相比对精神分裂症核心症状和与该疾病相关的认知缺陷的疗效和安全性。据推测，两种剂量的催产素都能改善症状和认知功能，且剂量越高（80 IU BID）效果越强。拟议的研究将提供关于开发催产素治疗精神分裂症的可行性的关键功效、剂量和安全性信息。

DESCRIPTION (provided by applicant): The peptide neurohormone, oxytocin plays a critical role in the regulation of a number of diverse central nervous system functions, which are highly relevant to schizophrenia. Several studies using animal models of psychosis indicate that oxytocin produces antipsychotic-like effects. A recent, small, proof-of-concept study, found that schizophrenia subjects taking intranasal oxytocin (40 IU BID) as an adjunct to existing antipsychotic drugs for 3 weeks had significantly reduced symptoms of psychosis and improved memory compared to subjects taking placebo. We now propose to perform a follow-up study adding a higher dose and increasing the duration of treatment with the goal of replicating and extending the promising preliminary findings. Specifically, the proposed study will test the efficacy and safety of 6-weeks of daily intranasal oxytocin (40 IU BID or 80 IU BID compared to placebo on core symptoms of schizophrenia and on cognitive deficits associated with the disorder. It is hypothesized that both oxytocin doses will improve symptoms and cognitive function with the higher dose (80 IU BID) producing stronger effects. The proposed study will provide critical efficacy, dosing and safety information regarding the feasibility of developing oxytocin as a treatment for schizophrenia.