A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Binge-eating Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Binge Frequency
研究概览
简要总结
This study evaluates the impact of intranasal oxytocin vs placebo in patients with binge eating disorder or episodes of binging. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes [reduction in bingeing frequency], and have a satisfactory safety and tolerability profile. We will also explore the predictive value of changes in homeostatic appetite, reward sensitivity, and impulse control, the identified underlying mediators, as assessed 4 weeks into the intervention, for treatment success after 8 weeks of the intervention.
详细描述
Study staff will screen patients for eligibility as per eligibility criteria. At least 60 eligible patients will be randomized 1:1 (active oxytocin: placebo) by an unblinded pharmacist. All other study staff and test subjects will be blinded. Study subject medical histories, physical exams, anthropometric measurements, labs, EKG's, and eating habits will be monitored over 8 weeks. Subjects will be evaluated at the following intervals: Baseline, week 2, week 4, week 8, and week 16 (8 weeks post-treatment).
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)
盲法说明
Study staff and patients are blinded. The pharmacist is unblinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18-70 years old
- •BMI greater than or equal to 18.5
- •BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV) OR Other Specified Feeding or Eating Disorder (OSFED) - Binge-eating disorder (of low frequency and/or limited duration) (SCID-5-RV) OR Bulimia Nervosa (BN) through excessive exercise and/or fasting to avoid gaining weight after episodes of binge eating. For individuals with OSFED-BED, the frequency of subjective and objective binge eating episodes will meet the frequency (Criterion D) for BED.
排除标准
- •Substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at the time of screening based on history and/or laboratory results
- •Medication changes that have not reached steady state concentration, measured by the equivalent of 5 half-lives of that medication
- •Use of medications for binge eating disorder or weight loss unless at a stable dose for at least 12 weeks
- •History of any of the following medical conditions: inflammatory bowel disease or untreated thyroid disease
- •Uncontrolled epilepsy (as defined by a seizure within the last 12 months)
- •Clinically relevant ventricular arrhythmias, coronary heart disease, known long QTc, and hypertrophic cardiomyopathy
- •Hematocrit >2% below normal
- •Hemoglobin A1c >8%
- •Use of insulin
- •ALT or AST >2.5 times upper limit of normal
- •Glomerular filtration rate < 60 mL/min
- •Hyponatremia. Note that, in order to be randomized, subjects must have Na ≥ 135 mEq/L.
- •Pregnancy or breastfeeding
- •Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
- •History of psychosis or active suicidal ideation
- •Major depressive disorder likely to require initiation or change in active treatment
- •Borderline personality disorder as assessed by the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD)
- •Current nicotine use, unless stable use for at least 12 weeks.
- •Participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization
- •Any significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or subject safety
研究组 & 干预措施
TNX-1900
Solution with oxytocin
干预措施: TNX-1900 (Tonix Pharmaceuticals) (Drug)
Placebo Arm
Solution without oxytocin
干预措施: Placebo (Drug)
结局指标
主要结局
Binge Frequency
时间窗: 8 weeks
Change in binge frequency as assessed by the Eating Disorder Examination clinical interview
Binge Frequency
时间窗: 8 weeks
Change in binge frequency as assessed by the Eating Disorder Examination clinical interview
次要结局
- Reward sensitivity(8 weeks)
- Impulse control(8 weeks)
- Reward sensitivity(8 weeks)
- Impulse control(8 weeks)
研究者
Elizabeth Austen Lawson
Director, Interdisciplinary Oxytocin Research Program
Massachusetts General Hospital