NCT02659488Unknown2 期
Effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder
Lindner Center of HOPE1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measurement of ventral prefrontal, striatal, and amygdala brain activation, assessed using food cues.
研究概览
简要总结
The purpose of this study is to explore the effect of Lisdexamfetamine on Prefrontal Brain Dysfunction in Binge Eating Disorder
详细描述
12-week, open-label LDX trial for BED including fMRI assessments to test the following specific predictions:
- At baseline, patients with BED will show greater ventral prefrontal, striatal, and amygdala brain activation to high-calorie food pictures (reward) than matched healthy comparison subjects.
- After 12 weeks of LDX treatment, BED will exhibit reduced ventral prefrontal, striatal and amygdala brain activation to food cues compared to baseline.
- BED patients who display cessation of binge eating and those who demonstrate clinical improvement after 12 weeks of LDX treatment will show greater reductions in ventral prefrontal, striatal, and amygdala brain activation to food pictures than patients who do not stop binge eating and those who do not improve, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Criteria for entering this study will include all of the following:
- •Subjects will meet the DSM-IV-TR criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months.
- •Subjects will report at least 3 binge eating (BE) days per week for the two weeks prior to LDX initiation prospectively documented in take-home binge diaries.
- •Women, through the ages of 18 and 55 years, inclusive.
- •Willingness to receive open-label LDX treatment for 12 weeks.
- •Willingness to receive an fMRI before and after 12 weeks of LDX treatment.
排除标准
- •Criteria for exclusion from this study will include all of the following:
- •Have concurrent symptoms of bulimia nervosa or anorexia nervosa.
- •Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. The following are considered to be adequate methods of birth control:
- •intrauterine device (IUD);
- •barrier protection;
- •a contraceptive implantation system (Norplant);
- •oral contraceptive pills;
- •a surgically sterile patient; and
- •abstinence. All female subjects will have a negative pregnancy test prior to randomization.
- •Subjects who are displaying suicidal ideation on the Columbia-Suicide Severity Scale (C-SSRS) (21), or a suicide attempt within the last year as defined by the C-SSRS, or homicidality.
- •Subjects who are receiving a psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers) intervention for BED that was begun within the 3 months before study entry. Subjects who are receiving psychotherapy that was initiated prior to 3 months of the beginning of the study will be allowed to continue to receive their psychotherapy during the trial only if they agree to not make any changes to the frequency or nature of their psychotherapy during the course of the drug trial.
- •A DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
- •Subjects who have used psychostimulants to facilitate fasting or dieting as a part of their eating disorder within the past 6 months; patients who have misused psychostimulants within the past 6 months; and patients who have a drug screen at the screening visit positive for psychostimulants.
- •A lifetime DSM-IV-TR history of ADHD, psychosis, mania or hypomania, or dementia.
- •History of any psychiatric disorder which might interfere with a diagnostic assessment, treatment, or compliance, or a current Montgomery Asberg Depression Scale (MADRS) (22) score ≥
- •Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease; clinically significant abnormalities on physical exam; or clinically significant laboratory abnormalities. Subjects should be biochemically euthyroid to enter the study.
- •Have a history of a structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, stroke, or other serious cardiovascular problem.
- •History of seizures, including clinically significant febrile seizures in childhood.
- •Have uncontrolled hypertension (>160/100) or tachycardia (heart rate >110). m. Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation.
- •Have clinically relevant abnormal laboratory results, specifically including hypokalemia.
- •Have a specific medical condition where LDX use is contraindicated, such as narrow angle glaucoma or Tourette's syndrome.
- •Subjects requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes warfarin, anticonvulsants, clonidine, theophylline, and pseudoephedrine.
- •Subjects who have received any psychotropic medications (other than hypnotics) within two weeks prior to LDX initiation, including monoamine oxidase inhibitors, tricyclics, selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, or psychostimulants.
- •Subjects who have received investigational medications or depot neuroleptics within three months prior to LDX initiation.
- •Subjects who have a known allergy to LDX or its constituents
- •An MRI scan is contraindicated in the subject for safety reasons, claustrophobia, or if the patient exceeds the weight limit of MRI scanner, ~350 pounds.
研究组 & 干预措施
Lisdexamfetamine
Other
During the Treatment Phase, subjects will be evaluated after 1, 2, 3, 4, 6, 8, 10, and 12 weeks (see Figure 2). The morning after completing the first fMRI scan, LDX will be started at 30 mg q AM (Baseline). After 1 week, LDX will then be increased to 50 mg q AM (Visit 1); after another week, LDX will be increased to 70 mg q AM (Visit 2). A single downward dose titration to 50 mg is allowed during week 3 if 70 mg/d is not tolerated. LDX dose at week 4 (50 or 70 mg/d) will be maintained for the next 8 weeks. Patients who do not tolerate 50 or 70 mg/day will be terminated. For patients who complete the 12-week treatment phase, LDX will be stopped at week 12 visit.
干预措施: Lisdexamfetamine (Drug)
结局指标
主要结局
Measurement of ventral prefrontal, striatal, and amygdala brain activation, assessed using food cues.
时间窗: Change from baseline to 12 weeks of brain activation
Investigators will statistically compare the brain response to food pictures of BED patients before and after receiving 12 weeks of LDX treatment.
次要结局
- Clinical Global Impression Improvement Scale (CGI-I)(weeks 1, 2, 3, 4, 6, 8, 10, 12)
- Binge Eating Scale (BES)(weeks 0,1, 2, 3, 4, 6, 8, 10, 12)
- Yale Brown Obsessive-Compulsive Scale modified for binge eating (YBOC-BE)(weeks 0,1, 2, 3, 4, 6, 8, 10, 12)
- Weight(weeks 0,1, 2, 3, 4, 6, 8, 10, 12)
研究者
研究点 (1)
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