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（由申请人提供）：肽神经激素催产素在调节多种中枢神经系统功能中发挥着关键作用，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，催产素会产生类似抗精神病药的作用。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，服用鼻内催产素（40 IU BID）作为现有抗精神病药物的辅助药物连续 3 周的精神分裂症受试者可显着减轻精神病症状并改善记忆力。我们现在建议进行一项后续研究，增加更高的剂量并延长治疗持续时间，以复制和扩展有希望的初步结果。具体来说，拟议的研究将测试为期 6 周的每日鼻内催产素（40 IU BID 或 80 IU 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有效性和安全性。据推测，两种催产素剂量都会改善症状和认知功能，其中较高剂量（80 IU BID）会产生更强的效果。拟议的研究将提供 有关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。