NCT01106053撤回3 期
An Exploration of the Effects of the Dopamine Agonist Pramipexole on Binge Antecedants, Binge Frequency, and Weight in Binge Eating Disorder
Neuropsychiatric Research Institute, Fargo, North Dakota0 个研究点开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Frequency of binge eating
研究概览
简要总结
This study is being conducted to evaluate the effects that the drug pramipexole has on mood, food craving, and other behaviors that may be related to binge eating disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age 18-50 years
- •Women of child-bearing potential and males must agree to practice an accepted method of birth control. All women must have a negative pregnancy test at baseline.
- •Good general health as demonstrated by history and physical examination.
- •Body mass index of 30 kg/m2 or higher at the screening visit.
- •Meet criteria for binge eating disorder as assessed through the SCID-1 and EDE.
排除标准
- •Subjects with any unstable medical condition, or any current or past medical condition which in the opinion of the study physician and/or the principal investigator may increase the risks associated with pramipexole and study participation. Medical appropriateness will be determined through history and physical exam.
- •Subjects with any current Axis I psychiatric diagnosis as determined through the Structured Clinical Interview for DSM-IV for Axis I disorders (SCID-1) interview (aside from BED).
- •Subjects with a Hamilton Depression Rating Scale score greater than or equal to 12 at the screening visit.
- •Subjects who report any history of hallucinations or delusions.
- •Participants taking an antidepressant or other regularly used psychotropic medication which may confound the study results
- •Subjects with any current or history of an impulse control spectrum disorder, other than binge eating disorder,(such as pathological gambling, compulsive shopping, etc.) at screening as determined by the Structured Clinical Interview for DSM-IV Impulse Control Module.
- •Subjects with any history of suicide attempts or current suicidal ideations.
- •Subjects that have used tobacco products on a routine basis within the past six months.
- •Subjects enrolled in any formal treatment programs or research protocols for binge eating disorder at present, or within the past 30 days.
- •Subjects routinely taking any medication known to produce weight change (ex. olanzapine, amitriptyline, steroid medications, etc., other than oral contraceptives, stable thyroid replacement drugs, etc.), or medications with drug-drug interactions with pramipexole.
- •Subjects who are currently breast-feeding.
- •Subjects who have participated in an investigational drug trial in the past 30 days.
- •Subjects who meet DSM IV-TR criteria for alcohol or drug abuse in the past year.
- •Subjects with an allergy to pramipexole or tablet constituents.
- •Subjects with hepatic dysfunction as determined through a hepatic panel obtained at the screening visit.
- •Subjects with an elevated blood pressure or pulse at screening (140/90 mmHg or above or pulse of greater than 100 beats/minute after being seated and stationary for at least five minutes, or as determined at the discretion of the study physician and/or principal investigator) or history of serious cardiac events (myocardial infarction, arrhythmia, stroke, etc).
- •Subjects with a history of renal dysfunction or with a creatinine clearance of less than 60 ml/min based upon a serum creatinine obtained during screening and as calculated with the Cockroft and Gault equation.
- •Subjects with a positive urine drug screen.
- •Any participant with Parkinson's disease or symptoms suggestive of probable Parkinson's disease.
- •Subjects who have an Epworth Sleep Scale (ESS) score of >7 at screening. ESS scores > 7 have been associated with an increased risk of sleep attacks (Plowman et al., 2005).
- •Any participant who demonstrates clinically significant orthostatic blood pressure changes or is symptomatic during the screening visit, as defined under "orthostatic blood pressure monitoring."
- •History of bariatric surgery.
- •Participants who report a history of obstructive sleep apnea, excessive fatigue, or any sleep disorder which in the opinion of the principal investigator or study medical personnel would increase the participant's risk of experiencing excessive somnolence with pramipexole.
- •Participant has had a change in medication regimen in the last month (dose, starting a new medication, or stopping a medication).
- •Participant is employed by, or has an immediate family member employed by NRI.
- •Participant has participated in a formal weight loss program in the last month (e.g. Weight Watchers, Jenny Craig, etc.)
研究组 & 干预措施
Pramipexole
Experimental
Open-label trial of pramipexole.
干预措施: Pramipexole (Drug)
结局指标
主要结局
Frequency of binge eating
时间窗: Baseline followed by weekly during the seven week protocol
次要结局
- Body weight(Baseline followed by weekly during the seven week protocol)
- Frequency and extent of craving for food using validated instruments(Baseline followed by weekly during the seven week protocol)
- Assessment of mood ratings using a validated instrument(Baseline followed by weekly during the seven week protocol)
研究者
Kristine Steffen
Reseach Scientist
Neuropsychiatric Research Institute, Fargo, North Dakota
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