SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder



Status:Completed
Conditions:Psychiatric, Eating Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:November 2012
End Date:September 2013

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The SPD489-344, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

The primary objective of the study is to demonstrate the efficacy of SPD489 compared with
placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating
Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as
days during which at least 1 binge episode occurs) per week as assessed by clinical
interview based on subject diary

Not Required

Inclusion Criteria:

The subject cannot be enrolled in the study before all of the following inclusion criteria
(including test results) are met:

1. Subject is between 18-55 years of age.

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

3. Subject has a BED diagnosis.

4. Subject's BED is of at least moderate severity with subjects reporting at least 3
binge eating days per week.

5. Female subjects must have a negative serum B-HCG pregnancy test and a negative urine
pregnancy test and agree to comply with any applicable contraceptive requirements.

Exclusion Criteria:

Subjects are excluded from the study if any of the following exclusion criteria are met:

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

2. Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior
therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED.

3. Subject has used psychostimulants to facilitate fasting or dieting as a part of their
BED.

4. Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.

5. Subject is considered a suicide risk, has previously made a suicide attempt, or is
currently demonstrating active suicidal ideation.

6. 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.

7. Subject has a history of moderate or severe hypertension.

8. Subject is female and pregnant or nursing.

9. Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures
for weight loss.
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Watertown, Massachusetts
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6141 Sunset Dr # 301
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Berlin,
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Boston, Massachusetts 02135
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8043 Cooper Creek Boulevard Suite 107
Bradenton, Florida 34201
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Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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