Phase 2
N=260
Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
Binge Eating Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01291173 ↗Enrolled (actual)
260
Serious AEs
1.2%
Results posted
Dec 2012
Primary outcome: Primary: Change From Baseline in Log Transformed Binge Days Per Week at Week 11 — -1.23; -1.24; -1.49; -1.57 Log days — p=0.8825
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- lisdexamfetamine dimesylate (SPD489) (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Log Transformed Binge Days Per Week at Week 11 |
-1.23; -1.24; -1.49; -1.57 | 0.8825 |
| SECONDARY Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks |
-4.07; -4.57; -5.10; -5.09 | 0.4676 |
| SECONDARY 1-Week Binge Response, Last Observation Carried Forward (LOCF) |
23; 28; 33; 35; 15; 20 | 0.3341 |
| SECONDARY 4-Week Binge Response |
13; 22; 27; 31 | 0.0937 |
| SECONDARY Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks |
37.1; 55.4; 60.9; 65.1; 19.4; 26.2 | — |
| SECONDARY Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks |
64.5; 84.6; 90.6; 93.7 | 0.0091 sig |
| SECONDARY Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11 |
-12.0; -15.0; -15.3; -17.0 | 0.0142 sig |
| SECONDARY Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11 |
-1.7; -1.9; -1.3; -1.6 | 0.7538 |
| SECONDARY Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11 |
-1.5; -0.9; -1.1; -0.6 | 0.2046 |
| SECONDARY Change From Baseline in Eating Inventory Score at Week 11 |
2.5; 4.4; 3.8; 4.3; -3.8; -5.6 | 0.0371 sig |
| SECONDARY Change From Baseline in Binge Eating Scale (BES) Score at Week 11 |
-12.2; -16.1; -17.6; -20.6 | 0.030 sig |
| SECONDARY Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11 |
-3.1; -5.8; -5.2; -6.9 | 0.0824 |
| SECONDARY Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11 |
1.3; 2.6; 2.4; 3.9; 4.9; 5.0 | 0.2504 |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01291173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.