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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01291173
First received: February 4, 2011
Last updated: November 28, 2012
Last verified: November 2012

February 4, 2011
November 28, 2012
May 2011
January 2012   (final data collection date for primary outcome measure)
Change From Baseline in Log Transformed Binge Days Per Week at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
Binge day is defined as a day during which at least 1 binge episode occurs.
Number of binge days per week [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01291173 on ClinicalTrials.gov Archive Site
  • Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks [ Time Frame: Baseline and up to 11 weeks ] [ Designated as safety issue: No ]
    The number of binge episodes per week as assessed by clinical interview based on subject diary.
  • 1-Week Binge Response, Last Observation Carried Forward (LOCF) [ Time Frame: Last 7 days on study ] [ Designated as safety issue: No ]
    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.
  • 4-Week Binge Response, Last Observation Carried Forward [ Time Frame: Last 28 days on study ] [ Designated as safety issue: No ]
    Subjects are free from binge episodes for 4 weeks.
  • Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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)
  • Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
    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)
  • Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks [ Time Frame: Up to 11 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Eating Inventory Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Binge Eating Scale (BES) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: No ]
    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).
  • Clinical Global Impressions (CGI) Rating Scale Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Rating Scale (HAM-A) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Three-Factor Eating Questionnaire (TFEQ) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Binge Eating Scale (BES) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Barratt Impulsiveness Scale (BIS-11) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Short Form-12 Health Survey (SF-12) Score [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Binge Eating Disorder

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Binge Eating Disorder
  • Drug: lisdexamfetamine dimesylate (SPD489)
    SPD489-30mg capsules taken once daily for up to 11 weeks
    Other Name: LDX, Vyvanse
  • Drug: lisdexamfetamine dimesylate (SPD489)
    SPD489 50mg capsules taken once-daily for up to 11 weeks
    Other Name: LDX, Vyvanse
  • Drug: lisdexamfetamine dimesylate (SPD489)
    SPD489 70mg capsule taken once-daily for up to 11 weeks
    Other Name: LDX, Vyvanse
  • Drug: Placebo
    Placebo capsule taken once daily for up to 11 weeks
  • Experimental: SPD489 30 mg
    Intervention: Drug: lisdexamfetamine dimesylate (SPD489)
  • Experimental: SPD489 50 mg
    Intervention: Drug: lisdexamfetamine dimesylate (SPD489)
  • Experimental: SPD489 70 mg
    Intervention: Drug: lisdexamfetamine dimesylate (SPD489)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
271
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01291173
SPD489-208
No
Shire
Shire
Not Provided
Principal Investigator: Susan McElroy, MD University of Cincinnati College of Medicine Lindner Ctr of HOPE
Shire
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP