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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
271
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Change From Baseline in Log Transformed Binge Days Per Week at Week 11
Binge day is defined as a day during which at least 1 binge episode occurs.
Time frame: Baseline and week 11
Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks
The number of binge episodes per week as assessed by clinical interview based on subject diary.
Time frame: Baseline and up to 11 weeks
1-Week Binge Response, Last Observation Carried Forward (LOCF)
The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline \[ie, a cessation of binge eating behavior\]), or a marked response (75 to \<100% reduction in binge episodes from baseline), or a moderate response (50 to \<75% reduction in binge episodes from baseline), or a negative/minimal response (\<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.
Time frame: Last 7 days on study
4-Week Binge Response
Subjects are free from binge episodes for 4 weeks.
Time frame: Last 28 days on study
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time frame: Baseline
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
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Placebo capsule taken once daily for up to 11 weeks
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Southwestern Research, Inc.
Beverly Hills, California, United States
Scripps Clinical Research Services
La Jolla, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
PCSD - Feighner Research
San Diego, California, United States
Florida Clinical Research
Bradenton, Florida, United States
Gulfcoast Clinical Research
Fort Myers, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, United States
...and 21 more locations
Time frame: up to 11 weeks
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: Up to 11 weeks
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11
The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.
Time frame: Baseline and week 11
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time frame: Baseline and week 11
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11
The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.
Time frame: Baseline and week 11
Change From Baseline in Eating Inventory Score at Week 11
The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.
Time frame: Baseline and week 11
Change From Baseline in Binge Eating Scale (BES) Score at Week 11
The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.
Time frame: Baseline and week 11
Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11
The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 - 120. Higher scores indicate increased impulsiveness.
Time frame: Baseline and week 11
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11
The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).
Time frame: Baseline and week 11