TOPIRAMATE IN THE TREATMENT OF PATHOLOGICAL GAMBLING

托吡酯治疗病态赌博

• 批准号: 7605301
• 负责人: ERIC HOLLANDER
• 金额: $ 0.06万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605301
• 关键词: Adverse effects; Adverse event; Anxiety; Appointment; Behavior; Computer Retrieval of Information on Scientific Projects Database; Consent; DSM-IV; Diagnosis; Disease; Dose; Double-Blind Method; Funding; Gambling; Grant; Impairment; Institution; Manic; Measures; Montgomery and Asberg depression rating scale; Mood stabilizers; Occupational; Outpatients; Participant; Pathological Gambling; Patient Appointment; Patients; Pharmaceutical Preparations; Placebo Control; Placebos; Psychiatrist; Randomized; Rate; Research; Research Personnel; Resources; Severities; Source; Symptoms; United States National Institutes of Health; Week; day; experience; social; topiramate

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study will assess the efficacy of topiramate in the treatment of pathological gambling. Pathological gambling (PG) is a debilitating disorder, generally leading to severe personal, familial, financial, social, and occupational impairments. In PG, the patient experiences a progressive inability to resist impulses to gamble, and gambling significantly disrupt the patient's functioning in the personal, familial, and/or vocational spheres. There are few trials using mood stabilizers for the treatment of pathological gambling. This is a 15-week, outpatient, multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of topiramate in 24 subjects who meet DSM-IV criteria for pathological gambling and also do not have a concurrent DSM-IV diagnosis or symptomatology that would preclude their participation in this study. After the initial assessment and consent to participate, the patient will begin treatment for pathological gambling using topiramate. The starting dose will be 25mg/day, and we propose to flexibly titrate that dose up to 400mg, depending on the participant's tolerability, throughout the 15-week study. Patients will return for appointments with the medication psychiatrist in weeks 1, 2, 4, 6, 8, 10, 12, 14, and 15. During these appointments, patients will be assessed for complicance with medication, side effects, adverse events, and no use of other concurrent medications. In addition, patients be rated on the Gambling Symptom Severity Scale, the PG-YBCS, the CGI-S and the CGI-I. At weeks 1 and 14, patients will also be rated on the Young Mania Rating Scale, Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale, and the Barratt Impulsiveness Scale. In this way, the efficacy of topiramate in pathological gambling will be evaluated. Hypothesis: It is hypothesized that there will be an improvement in gambling behavior and urge after 15 weeks of treatment with topiramate as compared to placebo. This will be measured through the Pathological Gambling - Yale Brown Obsessive Compulsive Scale and the Gambling Symptom Assessment Scale.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究将评估托吡酯在病理赌博治疗中的疗效。 病理赌博（PG）是一种使人衰弱的疾病，通常导致严重的个人，家庭，财务，社会和职业障碍。在PG中，患者经历了逐渐无法抵抗赌博的冲动，并且赌博严重破坏了患者在个人，家族和/或职业领域中的功能。 很少有使用情绪稳定器来治疗病理赌博的试验。 这是一项为期15周的门诊，多中心，随机，双盲，安慰剂对照，柔性剂量研究，对符合DSM-IV符合病理学赌博的DSM-IV标准的24名受试者的柔性剂量研究，并且没有同意的DSM-IV诊断或症状学，这将使他们在这项研究中的参与。 在初步评估并同意参加后，患者将开始使用托吡酯的病理赌博治疗。 开始剂量为25mg/天，我们建议在整个15周的研究中，根据参与者的耐受性，将其滴定至400mg的滴定量。 患者将在第1、2、4、6、8、10、12、14和15周与药物精神科医生的任命返回。在这些任命期间，将对患者进行对药物，副作用，不良事件的共识以及不使用其他并发药物的同意。 此外，将患者评为赌博症状严重程度，PG-YBC，CGI-S和CGI-I。 在第1和第14周，患者还将按年轻的躁狂评级量表，蒙哥马利 - 阿斯伯格抑郁量表（MADRS），汉密尔顿焦虑量评估量表和Barratt冲动量表进行评级。 通过这种方式，将评估托吡酯在病理赌博中的功效。 假设：假设与安慰剂相比，赌博行为将有所改善，并在接受托吡酯治疗15周后会有所改善。 这将通过病理赌博进行衡量 - 耶鲁棕色的强迫范围和赌博症状评估量表。