1/2-Anti-Psychotic Effects of Oxytocin

1/2-催产素的抗精神病作用

基本信息

批准号：
8299458
负责人：
DAVID FEIFEL
金额：
$ 25.52万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
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/8299458
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

项目摘要

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，催产素在调节许多与精神分裂症高度相关的中枢神经系统功能的调节中起关键作用。使用精神病动物模型的几项研究表明，催产素会产生抗精神病药样作用。最近的一项小型概念验证研究发现，接受鼻内催产素（40 IU BID）作为现有抗精神病药的辅助3周的精神分裂症受试者与接受安慰剂相比，精神病患者的辅助受试者已大大降低了精神病症状，并改善了记忆力。现在，我们建议进行一项后续研究，以增加较高的剂量并增加治疗持续时间，以复制和扩展有希望的初步发现。具体而言，拟议的研究将测试6周每日鼻内催产素的疗效和安全性（40 IU BID或80 IU BID与安慰剂相比，与安慰剂相比在精神分裂症的核心症状和与该疾病相关的认知缺陷方面的效率和安全性。这两种毒素剂量都会提高症状和认知能力的作用（80 iu bid），这两种剂量都会提高症状的作用（80 IU）。有关催产素作为精神分裂症治疗的可行性的关键功效，剂量和安全信息。