A study to examine the maintenance of study drug, SPD489, in adults subjects who are suffering from Binge Eating Disorder
- Conditions
- Binge eating disorder is characterized by recurrent, distressing episodes of uncontrolled consumption of large amounts of food (binge eating) without the inappropriate compensatory weight loss behaviors of bulimia nervosa. In May 2013, BED was formally added as a free standing diagnosis under DSM-5.Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-004457-88-SE
- Lead Sponsor
- Shire Development LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 412
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
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
(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.
• Subje
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