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

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ClinicalTrials.gov Identifier: NCT01291173
Recruitment Status : Completed
First Posted : February 8, 2011
Results First Posted : December 31, 2012
Last Update Posted : January 12, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Tracking Information
First Submitted Date  ICMJE February 4, 2011
First Posted Date  ICMJE February 8, 2011
Results First Submitted Date  ICMJE October 26, 2012
Results First Posted Date  ICMJE December 31, 2012
Last Update Posted Date January 12, 2015
Study Start Date  ICMJE May 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
Change From Baseline in Log Transformed Binge Days Per Week at Week 11 [ Time Frame: Baseline and week 11 ]
Binge day is defined as a day during which at least 1 binge episode occurs.
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
Number of binge days per week [ Time Frame: up to 11 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
  • Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks [ Time Frame: Baseline and up to 11 weeks ]
    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 ]
    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 [ Time Frame: Last 28 days on study ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
  • Clinical Global Impressions (CGI) Rating Scale Score [ Time Frame: up to 11 weeks ]
  • Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Score [ Time Frame: up to 11 weeks ]
  • Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score [ Time Frame: up to 11 weeks ]
  • Hamilton Anxiety Rating Scale (HAM-A) Score [ Time Frame: up to 11 weeks ]
  • Three-Factor Eating Questionnaire (TFEQ) Score [ Time Frame: up to 11 weeks ]
  • Binge Eating Scale (BES) Score [ Time Frame: up to 11 weeks ]
  • Barratt Impulsiveness Scale (BIS-11) Score [ Time Frame: up to 11 weeks ]
  • Short Form-12 Health Survey (SF-12) Score [ Time Frame: Up to 11 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Binge Eating Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * McElroy SL, Hudson JI, Mitchell JE, Wilfley D, Ferreira-Cornwell MC, Gao J, Wang J, Whitaker T, Jonas J, Gasior M. Efficacy and safety of lisdexamfetamine for treatment of adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA Psychiatry. 2015 Mar;72(3):235-46. doi: 10.1001/jamapsychiatry.2014.2162.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2012)
271
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2011)
260
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01291173
Other Study ID Numbers  ICMJE SPD489-208
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan McElroy, MD University of Cincinnati College of Medicine Lindner Ctr of HOPE
PRS Account Shire
Verification Date December 2014

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