Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)
研究概览
简要总结
This research study is being held at UCSD to determine whether the medication Quetiapine helps people suffering from anorexia nervosa by reducing core eating disorders symptoms. This study will see if the medication Quetiapine helps symptoms of anxiety, depression, and obsessionality, in addition to increasing BMI. Men and women between the ages of 18-65 and are currently suffering from anorexia nervosa are needed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for DSM-IV anorexia nervosa (restricting or binge-eating/purging types)
- •At least 15% below ideal body weight
- •Judged to be reliable to keep clinic visits and able to take all tests and examinations required by the protocol and be able to understand and decide whether or not to sign the Informed Consent.
排除标准
- •Subjects will not be included in the study who present with any of the following:
- •Schizophrenia or schizoaffective disorder (DSM-IV)
- •Any ECG abnormality considered clinically significant by the investigator
- •Subjects with liver enzymes elevated two times or more above normal
- •Other laboratory abnormalities considered clinically significant by the investigator including laboratory deviations requiring acute medical intervention
- •Pregnant women, women of childbearing potential not using medically accepted means of contraception (abstinence, IUD, birth control pills, barrier devices or implanted progesterone rods stabilized for at least three months), and lactating women
- •Serious suicide risk
- •Any medical condition that would preclude the outpatient treatment of anorexia nervosa or the use of quetiapine
- •Organic brain disease
- •History of severe allergies
- •Multiple adverse drug reactions or known allergy to quetiapine
- •Use of neuroleptic medications (except benzodiazepines) within 7 days preceding randomization
- •History of alcohol or substance abuse disorder as defined in the DSM-IV within the past 3 months.
研究组 & 干预措施
Placebo
The primary outcome was to determine the effect of quetiapine compared with placebo in terms of reducing core eating disorder symptoms on the Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS) and the Eating Disorder Inventory-2 (EDI-2).
干预措施: Placebo (Drug)
Quetiapine
Secondary outcomes were to determine if quetiapine is superior to placebo in reducing anxiety, depression and obsessionality assessed with the State Trait Anxiety Inventory (STAI), Hamilton Depression Rating Scale (HAM D) and Yale-Brown Obsessive Compulsive Scale, respectively. In addition, another secondary goal was to determine if quetiapine is superior to placebo in terms of weight gain. Adverse events were also determined.
干预措施: Quetiapine (Drug)
结局指标
主要结局
Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)
时间窗: Day 1 to LOCF (up to 8 weeks)
The YBC-EDS is an eight-item scale assessing severity of preoccupations and rituals.
Difference in Scores on the EDI-2 (Eating Disorders Inventory)
时间窗: Day 1 to LOCF (up to 8 weeks)
The EDI consists of 8 subscales measuring drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, and maturity fears
次要结局
- Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)(Day 1 to LOCF (up to 8 weeks))
- Difference in Scores on the STAI (State-Trait Anxiety Inventory)(Day 1 to LOCF (up to 8 weeks))
- Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)(Day 1 to LOCF (up to 8 weeks))
研究者
Walter Kaye
Program Director and Professor of Psychiatry
University of California, San Diego