Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Binge-Eating Relapse
研究概览
简要总结
This study will test the effectiveness of lisdexamfetamine (LDX) medication as a maintenance therapy for the treatment of binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, LDX medication results in superior maintenance and longer-term outcomes compared with placebo.
详细描述
Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide findings from a controlled test, amongst responders to acute treatments, whether LDX medication results in superior maintenance and longer-term outcomes than placebo. This is one of the few RCTs for BED of medication with follow-up after medication discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 64 years old
- •Meets DSM-5 criteria for binge-eating disorder
- •BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50
- •Medically cleared as determined by EKG and medical record review
- •Available for the duration of the treatment and follow-up (18 months)
- •Read, comprehend, and write English at a sufficient level to complete study-related materials
- •Able to travel to study location (New Haven, CT) for weekly visits
排除标准
- •Previous history of problems with LDX or other stimulants
- •Current psychostimulant use or use of any medication for ADHD
- •Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave
- •History of congenital heart disease, known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, cerebrovascular pathology including stroke, exertional chest pain, uncontrolled high blood pressure, and other serious heart problems.
- •History of severe renal, hepatic, neurological, or chronic pulmonary disease or other serious, unstable medical disorder.
- •Current uncontrolled hypertension
- •Current uncontrolled type I or II diabetes mellitus
- •Current uncontrolled thyroid illness
- •Gallbladder disease
- •Co-occurring severe mental illness requiring hospitalization or intensive treatment
- •Endorses current active suicidal or homicidal ideation with intent or plan
- •History or current alcohol or substance use disorder (smoking is not exclusionary)
- •Predisposition to seizures
- •History of anorexia nervosa or bulimia nervosa, or currently regularly self-inducing vomiting
- •Currently taking MAOI, SSRI or strong inhibitors of CYP2D6
- •History of allergy or sensitivity to the study medication or stimulant medications
- •Current use of medications contraindicated with the study medications
- •Currently breast feeding or pregnant, or not willing to use reliable form of contraception
- •Currently taking opioid pain medications or drugs
- •Currently using effective treatment (evidence-based therapeutic or psychopharmacologic) for eating and/or weight loss
- •Currently participating in another clinical study in which the participant is or will be exposed to an investigational or a non-investigational drug or device
- •Medical status judged by study physician as contraindication
研究组 & 干预措施
LDX
干预措施: Lisdexamfetamine Dimesylate (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Binge-Eating Relapse
时间窗: 12 month follow-up
Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of binge-eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 binge-eating episodes per month.
次要结局
- Change in Binge-Eating Frequency(From post-treatment to the 12-month follow-up)
- Change in Eating-Disorder Psychopathology (Continuous)(From post-treatment to the 12-month follow-up)
- Change in Depressive Symptoms(From post-treatment to the 12-month follow-up)
- Percent Change in Weight(From post-treatment to the 12-month follow-up)