Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder

• Status: Completed
• Trial end date: 2012-01-30
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Lisdexamfetamine Dimesylate

Criteria

Inclusion

• Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED).

• Binge eating disorder is of at least moderate severity in which subjects report at least 3 binge eating days per week.

• Subject has a body mass index (BMI) of >24 and <46.

Exclusion

• Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.

• Subject is considered a suicide risk or risk to harm others.