TOPIRAMATE IN THE TREATMENT OF PATHOLOGICAL GAMBLING

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究将评估托吡酯治疗病理性赌博的疗效。病态赌博（PG）是一种使人衰弱的疾病，通常会导致严重的个人、家庭、经济、社会和职业障碍。在PG中，患者逐渐无法抵抗赌博的冲动，赌博严重破坏了患者在个人、家庭和/或职业领域的功能。使用情绪稳定剂治疗病态赌博的试验很少。这是一项为期15周的门诊、多中心、随机、双盲、安慰剂对照、灵活剂量的托吡酯研究，24名受试者符合DSM-IV的病理性赌博标准，并且没有同时的DSM-IV诊断或症状，因此无法参与本研究。在初步评估并同意参与后，患者将开始使用托吡酯治疗病理性赌博。起始剂量为25mg/天，我们建议在整个15周的研究中，根据参与者的耐受性，灵活地将剂量滴定至400mg。患者将在第1、2、4、6、8、10、12、14和15周返回与药物精神科医生预约。在这些预约期间，将评估患者对药物的依从性、副作用、不良事件以及是否同时使用其他药物。此外，对患者进行赌博症状严重程度量表、PG-YBCS、CGI-S和CGI-I评分。在第1周和第14周，患者还将接受青年躁狂症评定量表、蒙哥马利-阿斯伯格抑郁评定量表（MADRS）、汉密尔顿焦虑评定量表和巴拉特冲动评定量表的评定。通过这种方式，将评估托吡酯对病理性赌博的疗效。假设：假设与安慰剂相比，托吡酯治疗15周后，赌博行为和冲动会有所改善。这将通过病态赌博-耶鲁布朗强迫症量表和赌博症状评估量表来衡量。

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.