Effects of Erythromycin on Binge Eating and GI Function in Bulimia Nervosa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Binge Frequency
研究概览
简要总结
This study will determine the effectiveness of the antibiotic erythromycin in enhancing gastrointestinal function and decreasing the frequency of binge eating in people with bulimia nervosa.
详细描述
Bulimia nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges. These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise. If left untreated, BN can lead to many serious health issues: tooth decay; irregular menstruation; bowel damage; constipation; heart and kidney disease; intestinal damage; puffiness, especially in the face and fingers; increased hair growth on the face and body; and mineral imbalances in the body. Although there is significant existing knowledge about the characteristics and treatment of BN, more information is needed about gastrointestinal (GI) function and its effect on binge eating behavior. This study will determine the effectiveness of the antibiotic erythromycin in enhancing GI function and decreasing the frequency of binge eating in people with BN.
Participants in this 8-week, double-blind study will first undergo gastric emptying and GI hormone release testing for 1 day. Within 1 week of completing these pre-treatment tests, participants will be randomly assigned to receive either erythromycin or placebo for 6 weeks. Upon medication assignment, participants will meet with a psychiatrist to receive their assigned medication. Participants will receive medication at weekly study visits. Medication dosage will be increased if symptoms do not improve, or decreased if adverse medication side effects are reported. A final day of gastric emptying and GI hormone release testing, as well as routine blood tests, will take place in Week 7, after 6 weeks of medication treatment. Participants' weight will be measured at Weeks 1, 4, and 7. Participants will also receive an EKG 1 week after each upward dosage adjustment. Patients will be informed of their medication assignment at the Week 7 study visit, and will be referred to a non-study clinician for further treatment.
For information on related studies, please see NCT00308776 and NCT00307190.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Meets criteria for bulimia nervosa
- •Duration of illness is greater than 1 year
- •Self-induces vomiting
- •Weighs 80%-120 % of ideal weight
排除标准
- •Significant medical illness
- •Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as defined by American Psychiatric Association criteria
- •Moderate to severe depression, as defined by a score greater than 18 on the Hamilton Depression Scales
- •Current diagnosis of organic mental disorder, factitious disorder, or malingering
- •History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with assessment or compliance with the study procedures
- •At risk for suicide
- •Current psychotropic medications and current medications that affect GI function or that inhibit or induce cytochrome three A gene expression
- •Currently pregnant, lactating, or planning to become pregnant
- •Drug or alcohol abuse within the 3 months prior to study entry
- •Abnormal EKG at baseline or 1 week following each upward dosage adjustment
- •Known intolerance to erythromycin, or related antibiotics
- •Abnormal results on liver function tests
- •Electrolyte abnormalities
研究组 & 干预措施
Erythromycin
Subjects with Bulimia Nervosa will take erythromycin.
干预措施: Erythromycin (Drug)
Placebo
Participants will take matched placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Binge Frequency
时间窗: Measured at Week 7
Binge frequency was assessed by patient diary. All patients were asked to keep a diary of the number of daily binge eating and vomiting episodes which was collected at each weekly visit.
Percent of Meal Remaining/Minute
时间窗: Measured at Week 7
percent of meal remaining/minute
次要结局
未报告次要终点
研究者
B. Timothy Walsh
Research Scientist
New York State Psychiatric Institute