A study to examine the efficacy and safety of study drug, SPD489, in adults subjects who are suffering from Binge Eating Disorder

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 356

Inclusion Criteria

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 356
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 greater or equal (>=) to 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 (Visit 0).
• Subject has any clinically significant laboratory abnormality prior to the Baseline Visit (Visit 0). Subjects with hypokalemia at the Screening Visit or prior to the Baseline Visit (Visit 0) will be excluded.
• Subject has

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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