Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder



Status:Completed
Conditions:Psychiatric, Psychiatric, Eating Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:January 2014
End Date:April 2015

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A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and
placebo, 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 and
Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by
the end of the Open-label Treatment Phase.


Inclusion Criteria:

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

2. Subject meets the following criteria for a diagnosis of BED:

- Recurrent episodes of binge eating. An episode of binge eating is characterized
by both of the following: eating, in a discrete period of time (eg, within a
2-hour period) an amount of food that is definitely larger than most people
would eat in a similar period of time under similar conditions, and a sense of
lack of control over the eating (eg, a feeling that one cannot stop eating or
control what or how much one is eating).

- The binge eating episodes are associated with at least 3 of the following:
eating much more rapidly than normal; eating until uncomfortably full; eating
large amounts of food when not feeling physically hungry; eating alone because
of being embarrassed by how much one is eating; feeling disgusted with oneself,
depressed, or feeling very guilty after overeating.

- Marked distress regarding binge eating.

- The binge eating occurs, on average, at least 2 days a week for 6 months.

- The episodes of binge eating do not occur exclusively during the course of
bulimia nervosa or anorexia nervosa.

3. Subject is consistently able to swallow a capsule.

Exclusion Criteria:

1. Subject has current diagnosis of bulimia nervosa or anorexia nervosa.

2. Subject is receiving psychotherapy or weight loss support within the past 3 months.

3. Subject has used psychostimulants to facilitate fasting or dieting within the past 6
months.

4. Subject has known history of symptomatic cardiovascular disease, advanced
arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart
rhythm abnormalities, coronary artery disease.

5. Subject has abnormal thyroid function.

6. Subject initiated treatment with a lipid lowering medication within the past 3
months.

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

8. Subject has a recent history (within the past 6 months) of suspected substance abuse
or dependence disorder.

9. Subject has glaucoma.

10. Subject is female and pregnant or nursing.

11. Subjects who have had bariatric surgery, lap bands, duodenal stents, or other
procedures for weight loss.
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