TREATMENT OF NEGATIVE SYMPTOMS & COGNITIVE IMPAIRMENTS

阴性症状的治疗

• 批准号: 6041519
• 负责人: STEPHEN R MARDER
• 金额: $ 25.37万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-01-15 至 2003-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6041519
• 关键词: antibiotics; antipsychotic agents; behavioral /social science research tag; clinical research; clinical trials; cognition; cognition disorders; combination chemotherapy; functional ability; glycine; human subject; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; mental disorder diagnosis; neuropsychological tests; neurotransmitters; quality of life; schizophrenia

The present proposal is a four site multi-center study designed to assess the efficacy of the cognitive impairments in patients with schizophrenia. These manifestations of schizophrenia account for much of the long-term morbidity, impaired social and occupational functioning, and poor quality of life observed in patients with schizophrenia. Persistent negative symptoms may either be primary (deficit symptoms) or secondary. At present, conventional and novel anti-psychotics have limited efficacy for secondary negative symptoms, and there are no known effective treatments for deficit symptoms. There are also no known agents with robust efficacy for cognitive impairments. The long-term objective of this application is to develop an effective treatment for persistent negative symptoms both primary and secondary, and cognitive impairments. The Specific Aims are to examine whether: 1) d-cycloserine and/or glycine is superior to placebo for the treatment of persistent primary and secondary negative symptoms; and 2) d-cycloserine and/or glycine is superior to placebo in the treatment of cognitive impairments in deficit and non- deficit patients. Secondary goals include:" a) to establish a standard clinical trial methodology to assess the therapeutic efficacy of potential treatments of persistent negative symptoms and cognitive impairments; and b) to describe the relationship between cognitive impairments, as assessed by neuropsychological test performance, and negative symptoms in the clinical trial context. The study will be a 16-week double-blind, parallel groups comparison of adjunctive medication (i.e., d-cycloserine and glycine) and placebo. Neuropsychological tests will be used to assess cognitive functioning, and will be administered at baseline and at the end of the study. The study will provide new information on the efficacy of d- cycloserine and glycine for both persistent primary and secondary negative symptoms and its effect on cognitive functioning.

本提案是一项四中心多中心研究，旨在评估精神分裂症患者认知障碍的疗效。精神分裂症的这些表现是精神分裂症患者长期发病、社会和职业功能受损以及生活质量差的主要原因。持续的阴性症状可能是原发性的（缺陷症状）或继发性的。目前，传统和新型抗精神病药物对继发性阴性症状的疗效有限，并且尚无已知的针对缺陷症状的有效治疗方法。也没有已知的药物对认知障碍具有强大的功效。该应用的长期目标是开发一种针对原发性和继发性持续阴性症状以及认知障碍的有效治疗方法。具体目标是检查： 1) d-环丝氨酸和/或甘氨酸在治疗持续性原发性和继发性阴性症状方面是否优于安慰剂； 2) d-环丝氨酸和/或甘氨酸在治疗缺陷和非缺陷患者的认知障碍方面优于安慰剂。次要目标包括：a) 建立标准的临床试验方法，以评估持续阴性症状和认知障碍的潜在治疗方法的治疗效果；b) 描述通过神经心理学测试表现评估的认知障碍与阴性症状之间的关系该研究将对辅助药物（即 D-环丝氨酸和甘氨酸）和安慰剂进行为期 16 周的双盲、平行分组比较。评估认知功能，并将在基线和研究结束时进行该研究将提供有关 d-环丝氨酸和甘氨酸对持续的原发性和继发性阴性症状及其对认知功能的影响的新信息。