SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Binge Eating Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01718483 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SPD489 (Lisdexamfetamine dimesylate) (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12) |
-2.51; -3.87 | <0.001 sig |
| SECONDARY Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores |
47.3; 82.1 | <0.001 sig |
| SECONDARY Percentage of Participants With a 4-Week Cessation From Binge Eating |
14.1; 40.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Body Weight at Week 12 |
0.11; -6.25 | <0.001 sig |
| SECONDARY Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 |
-8.28; -15.68 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks |
0.122; -0.077 | <0.001 sig |
| SECONDARY Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks |
-0.094; -0.305 | <0.001 sig |
| SECONDARY Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks |
0.01; -0.02 | 0.308 |
| SECONDARY Binge Eating Response |
26.6; 47.1; 15.2; 31.6; 17.9; 11.8 | <0.001 sig |
| SECONDARY Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12) |
-3.49; -5.27 | <0.001 sig |
| SECONDARY Change From Baseline in Eating Inventory Scores at Week 12 |
1.63; 3.27; -2.12; -6.31; -1.90; -6.60 | <0.001 sig |
| SECONDARY Change From Baseline in Binge Eating Scale (BES) Score at Week 12 |
-8.55; -18.87 | <0.001 sig |
| SECONDARY Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12 |
-3.09; -3.40 | 0.706 |
| SECONDARY EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility |
82.6; 87.2; 14.0; 10.7; 2.8; 2.1 | — |
| SECONDARY EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care |
89.3; 95.7; 6.7; 3.2; 3.9; 1.1 | — |
| SECONDARY EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities |
78.0; 87.1; 14.7; 9.7; 6.2; 3.2 | — |
| SECONDARY EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort |
64.6; 71.1; 27.5; 20.9; 7.3; 7.5 | — |
| SECONDARY EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression |
70.2; 72.2; 19.7; 16.6; 7.9; 9.1 | — |
| SECONDARY Columbia-Suicide Severity Rating Scale (C-SSRS) |
3; 2; 0; 0 | — |
| SECONDARY Amphetamine Cessation Symptom Assessment (ACSA) Total Score |
7.3; 5.7 | — |
Summary
Eligibility Criteria
Inclusion Criteria -
- Subject is between 18-55 years of age.
- Subject meets the following DSM-IV-TR 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.
- Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week for the 14 days prior to the Baseline Visit (Visit 0) as documented in the subject's binge diary. A binge day is a day during which at least 1 binge eating episode occurs.
- Female subjects must have a negative serum B HCG pregnancy test and a negative urine pregnancy test.
Exclusion Criteria-
- Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
- Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED within 3 months.
- Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED within 6 months.
- Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
- Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator.
- Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
- Subject has recently initiated treatment with a lipid-lowering medication (within the past 3 months).
- Subject has a history of moderate or severe hypertension.
- Subject is female and pregnant or nursing.
- Subjects who have had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.
Data sourced from ClinicalTrials.gov (NCT01718483). 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.