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

Shire

Status and phase: Completed; Phase 2

Conditions: Binge Eating Disorder

Treatments: Drug: lisdexamfetamine dimesylate (SPD489); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01291173

SPD489-208

Details and patient eligibility

About

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

Enrollment: 271 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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271 participants in 4 patient groups, including a placebo group

SPD489 30 mg

Experimental group

Treatment:

Drug: lisdexamfetamine dimesylate (SPD489)

Drug: lisdexamfetamine dimesylate (SPD489)

Drug: lisdexamfetamine dimesylate (SPD489)

SPD489 50 mg

Experimental group

Treatment:

Drug: lisdexamfetamine dimesylate (SPD489)

Drug: lisdexamfetamine dimesylate (SPD489)

Drug: lisdexamfetamine dimesylate (SPD489)

SPD489 70 mg

Experimental group

Treatment:

Drug: lisdexamfetamine dimesylate (SPD489)

Drug: lisdexamfetamine dimesylate (SPD489)

Drug: lisdexamfetamine dimesylate (SPD489)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo