EUCTR2012-004457-88-DE进行中（未招募）1 期
A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder - SPD489-346
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 412
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:
- •Subject is between 18-55 years of age (or age of majority if greater
- •than 18 years of age, as defined by local regulations), inclusive, at the
- •time of consent.
- •Subject meets DSM-IV-TR criteria for a diagnosis of BED.
- •Subject's BED is of at least moderate severity with subjects reporting
- •at least 3 binge eating days per week for the 14 days prior to the
- •Baseline Visit (Visit 0) as documented in the subject's binge diary. A
- •binge day is a day during which at least 1 binge eating episode occurs.
- •Subject must have a CGI-S score superior or equal to 4 at the
- •Screening Visit (Visit -1) and Baseline Visit (Visit 0).
- •Subject has a BMI of superior or equal to 18 and inferior or equal to 45
- •at the Screening Visit (Visit -1) and the Baseline Visit (Visit 0).
- •Subject is able to provide written, personally signed, and dated
- •informed consent to participate in the study before completing any
- •study-related procedures.
- •Subject is willing and has an understanding and ability to fully comply
- •with study procedures and restrictions defined in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 412
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are excluded from the study if any of the following exclusion
- •criteria are met:
- •Subject has current diagnosis of bulimia nervosa or anorexia nervosa
- •as defined by the SCID-I eating disorders module.
- •Subject is receiving psychotherapy (eg, supportive psychotherapy,
- •cognitive behavior therapy, interpersonal therapy) or weight loss
- •support (eg, Weight Watchers) for BED that began within the 3 months
- •prior to the Screening Visit (Visit -1). Subjects who are receiving
- •psychotherapy or weight loss support that was initiated >=3 months
- •prior to the Screening Visit (Visit -1) will be allowed to continue to
- •receive psychotherapy or weight loss support during the study only if
- •they agree to not make any changes in the frequency or nature of their
- •psychotherapy or weight loss support during the course of this study.
- •Subject has a current comorbid Axis I or Axis II psychiatric disorder
- •that is either controlled with medications prohibited in this study or is
- •uncontrolled and associated with significant symptoms (note: subjects
- •with mild mood or anxiety symptoms that do not meet criteria for Axis I
- •disorder, do not require treatment based on the investigator's
- •assessment, and do not confound efficacy or safety assessments in the
- •opinion of the examining investigator may be included).
- •Subject has a lifetime history of psychosis, mania, hypomania,
- •dementia, or ADHD.
- •Subject is considered a suicide risk in the opinion of the investigator,
- •has previously made a suicide attempt, or is currently demonstrating
- •active suicidal ideation. Subjects with intermittent passive suicidal
- •ideation are not necessarily excluded based on the assessment of the
- •investigator.
- •Subject has a recent history (within the past 6 months) of suspected
- •substance abuse or dependence disorder in accordance with DSM-IV-TR
- •criteria. Subjects with a lifetime history of amphetamine, cocaine, or
- •other stimulant abuse and/or dependence will be excluded. Nicotine
- •dependence is not exclusionary.
- •Subject has a concurrent chronic or acute illness (such as severe
- •allergic rhinitis, an infectious process requiring antibiotics, or diabetes),
- •disability, or other condition that might confound the results of safety
- •assessments administered in the study or that might increase risk to the
- •subject. Subject will be excluded if he or she has any additional
- •condition(s) that in the investigator's opinion would prohibit the subject from completing the study or would not be in the best interest of the
- •subject to participate in the study. This would include any significant
- •illness or unstable medical condition that could lead to difficulty in
- •complying with the protocol. Mild, stable asthma is not exclusionary.
- •Subject has known history of symptomatic cardiovascular disease,
- •advanced arteriosclerosis, structural cardiac abnormality,
- •cardiomyopathy, serious heart rhythm abnormalities, coronary artery
- •disease, or other serious cardiac problems that may place them at
- •increased vulnerability to the sympathomimetic effects of a stimulant
- •medication.
- •Subject has a known family history of sudden cardiac death or
- •ventricular arrhythmia.
- •Subject has any clinically significant ECG prior to the Baseline Visit
- 另有 4 项未显示
研究者
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