NCT01921582已完成2 期
A Randomized Comparison of Osmotic Release Oral System Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Obese Patients With Binge Eating Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Frequency of binge episodes/days, as assessed by prospective daily binge diary
研究概览
简要总结
The purpose of this study is to determine whether methylphenidate is effective in the treatment of binge eating disorder, in a randomized controlled trial extended release methylphenidate versus cognitive behavioral therapy for binge eating disorder in overweight or obese adult females.
详细描述
Fifty-six adult female outpatients with binge eating disorder will receive 12 weeks of methylphenidate (dosage 18-72 mg) or 12 sessions of manualized cognitive behavioral therapy. Participants will complete interviewer-rated and self-report measures of eating, mood, attention, and personality features before treatment, after 6 weeks of treatment, immediately after treatment is completed, and 3 months after treatment is completed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Binge-Eating Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
- •Body Mass Index ≥ 25
- •Must be fluent in English
- •Must be capable to give informed consent
排除标准
- •Current pregnancy or lactation
- •Psychotherapy or behavioural treatment for eating or weight initiated during the past month
- •Psychotropic or investigational medications initiated / changed during the past three months
- •Concomitant use of another psychostimulant
- •Current mental disorders that are acute/unstable, that require alternate treatment, and/or that preclude ability to complete research protocol including mania, psychosis, substance use (alcohol or drugs), dementia, organic brain disorders, mental retardation
- •Current severe suicidality or homicidality
- •Current uncontrolled medical conditions that affect weight or BED symptoms or that are contraindicated for methylphenidate including metabolic, neurological, hepatic, renal, cardiovascular, hematological, ophthalmic, or endocrine diseases
- •Other serious medical illness or event such as acute myocardial infarction or stroke during the past six months
- •History of seizures or tics in the past year
- •Diagnosis or family history of Tourette's
- •Clinically relevant laboratory results, including: Tachycardia as indicated by heart rate > 110; Hypertension as indicated by blood pressure parameters > 140 (systolic) and 90 (diastolic); Arrhythmias or conduction abnormalities as indicated by ECG parameters QTC> 460msec, QRS>120 msec, and PR>200 msec; Abnormal laboratory results (e.g., hypokalemia) as indicated by values > 20% above the upper range of the laboratory standard of a basic metabolic screen
- •Current medications that affect weight
- •Current medications that are contraindicated for methylphenidate
研究组 & 干预措施
Methylphenidate
Experimental
Methylphenidate (TEVA-METHYLPHENIDATE ER-C)
- Dosage: 18 mg/day at Week 1; 36 mg/day at Week 2; 54 mg/day at Week 3; 72 mg/day at Week 4. Dosage levels may be maintained or decreased to manage medication side effects.
- Dosage form: tablet
- Dosage frequency: daily
- Duration: 12 weeks total
干预措施: Methylphenidate (Drug)
Cognitive Behavioral Therapy
Active Comparator
Cognitive Behavioral Therapy
- 12 individual 50-minute appointments over the course of up to 14 weeks
- According to Fairburn, Marcus, and Wilson (1993)
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Frequency of binge episodes/days, as assessed by prospective daily binge diary
时间窗: After 12 weeks of treatment
次要结局
- Frequency of objective binge episodes and overall illness severity, as assessed by both the Eating Disorder Examination Interview and Questionnaire(After 12 weeks of treatment)
- Quality of life, as assessed by the Quality of Life Inventory(After 12 weeks of treatment)
- Associated features of binge eating as captured by the Dutch Eating Behavior Questionnaire and Binge Eating Scale(After 12 weeks of treatment)
- Clinician impression of illness severity and improvement, as assessed by the Clinical Global Impression scale(After 12 weeks of treatment)
- Body Mass Index(After 12 weeks of treatment)
研究者
Lena Quilty
Independent Scientist
Centre for Addiction and Mental Health
研究点 (1)
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