Eltoprazine for the Treatment of Cognitive Dysfunction Assoc. With Schizophrenia

艾托拉嗪治疗认知功能障碍。

• 批准号: 8303212
• 负责人: Emer Leahy
• 金额: $ 35万
• 依托单位: PSYCHOGENICS, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-18 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8303212
• 关键词: Adult; Adverse effects; Adverse event; Affective Symptoms; Aggressive behavior; Agonist; Antipsychotic Agents; Attention; Attention deficit hyperactivity disorder; Back; Brief Psychiatric Rating Scale; Clinical; Clinical Trials; Cognition; Cognitive; Consensus; Disease; Dopamine; Dopamine D2 Receptor; Dose; Double-Blind Method; Drug Interactions; Electrocardiogram; Electroencephalography; Excision; Functional disorder; Gender; Heterogeneity; Impaired cognition; Impairment; Impulsivity; Laboratories; Lead; Marketing; Measures; Medical; Mental Depression; Mental disorders; Monitor; Mus; Neurocognitive; Outcome Measure; Patients; Performance; Pharmaceutical Preparations; Phase; Placebo Control; Placebos; Population; Prevalence; Property; Race; Rattus; Research Personnel; Safety; Schizophrenia; Serious Adverse Event; Serotonin Receptor 5-HT1A; Short-Term Memory; Symptoms; Testing; Therapeutic Agents; Time; Work; blind; clinically significant; design; executive function; falls; improved; inattention; memory recognition; object recognition; performance tests; receptor; treatment effect

DESCRIPTION (provided by applicant): Schizophrenia is a common and highly disabling psychiatric disorder with a population prevalence around 1%. The manifestations of schizophrenia fall into three major domains: 1) "positive" symptoms; 2) "negative" symptoms: and 3) cognitive dysfunction. All marketed therapies for the treatment of Schizophrenia are antagonists or partial agonists of the D2 dopamine receptor which exert their effects primarily on the positive symptoms with little or no effect on negative symptoms or cognitive dysfunction. PsychoGenics proposes to study the effects of a selective 5-HT1A/1B receptor partial agonist, eltoprazine, as an adjunctive treatment for cognitive impairment associated with prefrontal dysfunction in a double-blind, placebo-controlled, parallel study comparing the effects of eltoprazine at 5mg BID to placebo as an adjunct to standard antipsychotic treatment over an eight week period. The aims of this study are: 1. Assess whether eltoprazine can improve cognitive impairment associated with schizophrenia on a summary score across all 7 cognitive domains from the MATRICS test battery administered at baseline, 4 weeks and 8 weeks, CPT-AX and 2-Back measures of attention and working memory. 2. Determine whether eltoprazine has an effect on positive, negative or affective symptoms by administering the Brief Psychiatric Rating Scale (BPRS) for positive symptoms, Calgary Depression Scale (CDS) for depression, Scale for Assessment of Negative Symptoms (SANS) for negative symptoms. 3. Assess the safety of eltoprazine in a schizophrenic population and determine if there are any drug interaction effects by administering the Simpson-Angus Extrapyramidal Rating Scale (SAS), vital signs including 12 lead EEG and other laboratory measures.

描述（由申请人提供）：精神分裂症是一种常见且高度致残的精神疾病，人群患病率约为 1%。精神分裂症的表现主要分为三大领域：1）“阳性”症状； 2)“阴性”症状：以及3)认知功能障碍。所有用于治疗精神分裂症的市售疗法都是 D2 多巴胺受体的拮抗剂或部分激动剂，其主要对阳性症状发挥作用，而对阴性症状或认知功能障碍影响很小或没有影响。 PsychoGenics 提议在一项双盲、安慰剂对照、平行研究中研究选择性 5-HT1A/1B 受体部分激动剂艾托拉嗪作为辅助治疗与前额叶功能障碍相关的认知障碍的效果，该研究比较了 5 毫克艾托拉嗪的效果BID 安慰剂作为标准抗精神病药物治疗的辅助药物，为期八周。本研究的目的是： 1. 根据基线、第 4 周和第 8 周、CPT-AX 和 2-Back 进行的 MATRICS 测试组的所有 7 个认知领域的汇总分数，评估艾托拉嗪是否可以改善与精神分裂症相关的认知障碍注意力和工作记忆的测量。 2. 通过针对阳性症状使用简明精神病评定量表 (BPRS)、针对抑郁症使用卡尔加里抑郁量表 (CDS)、针对阴性症状使用阴性症状评估量表 (SANS) 来确定艾托拉嗪是否对阳性、阴性或情感症状有影响。 3. 评估艾托拉嗪在精神分裂症人群中的安全性，并通过实施辛普森-安格斯锥体外系评定量表（SAS）、生命体征（包括 12 导联脑电图）和其他实验室测量来确定是否存在任何药物相互作用。