A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Score on the Geriatric Depression Scale
研究概览
简要总结
The purpose of this research study is to see if tetrabenazine, which is commonly used to treat Huntington's Disease (HD), reduces the problems of impulsivity that are common in patients with HD. Investigators will also see how the medicine affects aspects of thinking and mood.
详细描述
This study is an open-label assessment of behavioral symptoms including depression, impulsivity, and suicidal ideations in patients prior to, and after, taking a stable dose of TBZ for Huntington's disease. All subjects will be evaluated with tests of depression (Beck Depression Scale), impulsivity (QUIP, BIS-11, and computerized impulsivity scales), and suicidal ideation (Columbia Suicide Scale) as a safety measure before they actually start taking TBZ. Since there is a significant lack of awareness of emotional and cognitive symptoms (anosagnosia) in patients with HD, collateral sources will be asked to fill out similar questionnaires based on their knowledge and observation of the patient. Patients and collaterals will be asked to return to the clinic for an identical evaluation plus adverse events, after they have been on a stable dose of TBZ for 4 weeks, which would be 8 ± 1 week after initiating TBZ. Patients will be titrated over 3-5 weeks to best dose as determined by the investigator, up to a maximum of 75 mg/day. As patients are titrating, there will be several telephone contacts conducted. The initial dose will be 12.5 mg BID. Best dose will be largely determined by adverse events and subjective efficacy. Determination of best dose will include two scheduled phone calls and others as needed. Other medications will remain stable between visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For HUntington's Disease (HD) patients only--Definite HD as indicated by positive gene testing or typical symptoms in the context of family history of HD.
- •A moderate degree of impulsivity as measured by the Barrat Impulsivity Scale (BIS). (>65)
- •Must be symptomatic in the opinion of the investigator. Standard clinical criteria for symptomatic HD will be employed, any motor signs c/w HD, usually chorea.
- •Patient is cognitively alert and able to answer/understand.
排除标准
- •Patient requires the assistance of another person to walk, or is non-ambulatory.
- •Patient is severely impaired cognitively.
- •Patients taking neuroleptic (dopamine blocking) medications within the past 14 days.
- •patient is actively suicidal, has untreated or inadequately treated depression, has impaired hepatic function, is taking MAO inhibitors or is taking reserpine or has been off of reserpine for less than 20 days
研究组 & 干预措施
Tetrabenazine
Xenazine (tetrabenazine), pill, dosage titrated to effect, three times a day, 12 weeks
干预措施: Tetrabenazine (Drug)
结局指标
主要结局
Change in Score on the Geriatric Depression Scale
时间窗: Baseline and 8 weeks
This assessment detects depressive symptoms in subjects and is a commonly used neuropsychological scale. It is less influenced by motor / somatic symptoms compared to other depression scales.
Change in Score on the Minnesota Impulsivity Disorders Interview
时间窗: Baseline and 8 weeks
This is a clinician-administered screening instrument that had shown good reliability and validity in studies of adult and adolescent psychiatric patients.
Change in Score on the Barrat Impulsivity Scale
时间窗: Baseline and 8 weeks
Scale is the most widely used self-report measure of impulsive personality traits. The BIS-11 is a 30-item self-report questionnaire that is scored to yield a total score, three second-order factors, and six first-order factors.
Change in Score on the Iowa Gambling Task
时间窗: Baseline and 8 weeks
a widely used, but complex, neuropsychological task of executive function in which mixed outcomes (gains and losses) are experienced together, to performance on a relatively simpler descriptive task, the Cups task, which isolates adaptive decision making for achieving gains and avoiding losses. It is very predictive of impulsive personality traits
Change in Score on the Questionnaire for Impulsive Disorders in Parkinson's Disease
时间窗: Baseline and 8 weeks
A newly developed and tested tool for measuring impulsivity in PD patients.
Change in Score on the Montreal Cognitive Impairment Assessment
时间窗: Baseline and 8 weeks
cognitive screening test designed to assist Health Professionals for detection of mild cognitive impairment, including Alzheimer's disease.
次要结局
- Change in Score on the United Huntington's Disease Rating Scale - Motor section(Baseline and 8 weeks)
研究者
William Ondo, MD
Professor
The Methodist Hospital Research Institute