2/2-Antipsychotic Effects of Oxytocin

2/2-催产素的抗精神病作用

• 批准号: 8299491
• 负责人: STEVEN G POTKIN
• 金额: $ 30.98万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-11 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8299491
• 关键词: Animal Model; Antipsychotic Agents; California; Chronic; Clinical; Clinical Trials; Cognitive; Cognitive deficits; Development; Disease; Dose; Double-Blind Method; Drug Formulations; Drug Kinetics; Effectiveness; Experimental Designs; Goals; Hormones; Intervention; Intervention Studies; Investigational Drugs; Lead; Marketing; Memory; Mental disorders; Nervous System Physiology; Neuraxis; Neurohormones; Oxytocin; Pathway interactions; Patients; Peptides; Performance; Pharmaceutical Preparations; Pharmacodynamics; Phase; Pilot Projects; Placebos; Play; Population; Psychotic Disorders; Randomized; Recruitment Activity; Registries; Regulation; Research; Role; Safety; Sample Size; Sampling; Schizophrenia; Short-Term Memory; Site; Study Subject; Symptoms; Testing; Therapeutic; Therapeutic Effect; Time; Verbal Learning; base; cognitive function; drug candidate; efficacy testing; follow-up; improved; innovation; interest; memory recall; neuropsychiatry; novel; placebo controlled study; research study; treatment duration

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.

描述(申请人提供)：缩宫素是一种多肽神经激素，在调节多种不同的中枢神经系统功能方面起着关键作用，这些功能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，催产素产生抗精神病药物样的作用。最近的一项小型概念验证研究发现，与服用安慰剂的受试者相比，精神分裂症受试者在现有抗精神病药物的基础上鼻内注射催产素(40IU，bid)3周后，精神病症状显著减少，记忆力得到改善。我们现在建议进行一项后续研究，增加更高的剂量和延长治疗时间，目的是复制和扩大有希望的初步发现。具体地说，拟议的研究将测试每天6周的鼻腔内催产素(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障碍的疗效和安全性。据推测，两种剂量的催产素都会改善症状和认知功能，但剂量越大(80IU，bid)效果越强。这项拟议的研究将提供有关开发催产素作为精神分裂症治疗的可行性的关键疗效、剂量和安全性信息。