SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Phase 3

Completed

Conditions: Binge Eating Disorder

Interventions: Drug: Placebo
Drug: SPD489 (Lisdexamfetamine dimesylate)

Registration Number: NCT01718509

Lead Sponsor: Shire

Brief Summary: The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary

Detailed Description: Not Required

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 390

Inclusion Criteria

The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:

Subject is between 18-55 years of age.
Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:
Subject has a BED diagnosis.
Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.
Female subjects must have a negative serum B-HCG pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements.

Exclusion Criteria

Subjects are excluded from the study if any of the following exclusion criteria are met:

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.
Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED.
Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
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 a history of moderate or severe hypertension.
Subject is female and pregnant or nursing.
Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
SPD489 (Lisdexamfetamine dimesylate)	SPD489 (Lisdexamfetamine dimesylate)	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12	Baseline and Visit 8 Which Spans Weeks 11/12	Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks	Baseline and up to 12 weeks
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12	Baseline and Visit 8 Which Spans Weeks 11/12
Percent Change From Baseline in Body Weight (kg) at Week 12	Baseline and week 12
Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks	Baseline and up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression	Up to 12 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to 12 weeks	C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Up to 12 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 (Y-BOCS-BE) Total Score at Week 12	Baseline and week 12	The Y-BOCS-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. Reduction in total score indicates improvement.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort	Up to 12 weeks
Percent of Participants With a 4-Week Cessation From Binge Eating	Up to 12 weeks	4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.
Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks	Baseline and up to 12 weeks
Binge Eating Response	Up to 12 weeks	Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows: -1-week Cessation = 100% reduction in binge episodes during the preceding 7 days -Marked Reduction = 99% to 75% reduction during the time since the previous visit -Moderate Reduction = 74% to 50% reduction during the time since the previous visit -Negative to Minimal Reduction = \<50% reduction during the time since the previous visit
Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks	Baseline and up to 12 weeks	The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from "1" (almost never) to "5" (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.
Change From Baseline in Eating Inventory Scores at Week 12	Baseline and week 12	There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.
Change From Baseline in Binge Eating Scale (BES) Score at Week 12	Baseline and week 12	The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility	Up to 12 weeks	Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care	Up to 12 weeks
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities	Up to 12 weeks
Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.	Baseline and Week 12	ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity. Calculated as Baseline (Day 0) - Week 12 ACSA scores.

Trial Locations

Locations (43): Potomac Grove Clinical Research Center
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Gaithersburg, Maryland, United States
Radiant Research, Inc.
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San Antonio, Texas, United States
Scripps Clinical Research Services
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La Jolla, California, United States
UMN Medical School, Dept of Psychiatry
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Minneapolis, Minnesota, United States
NeuroTrials Research, Inc.
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Atlanta, Georgia, United States
Advanced Research Institute
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Ogden, Utah, United States
Southern California Research, LLC
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Beverly Hills, California, United States
CNS Clinica at the Brain Resource Center
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New York, New York, United States
Capstone Clinical Research
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Libertyville, Illinois, United States
Klinische Forschung Berlin-Mitte GmbH
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Berlin, Germany
PCSD - Feighner Research
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San Diego, California, United States
Bioscience Research, LLC
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Mount Kisco, New York, United States
Boston Clinical Trials
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Boston, Massachusetts, United States
American Medical Research
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Oak Brook, Illinois, United States
The Craig and Frances Lindner Center of Hope
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Mason, Ohio, United States
CRI Lifetree
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Philadelphia, Pennsylvania, United States
Clinical Research Associates, Inc.
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Nashville, Tennessee, United States
Klinische Forschung Schwerin GmbH
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Schwerin, Germany
Lehigh Center for Clinical Research
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Allentown, Pennsylvania, United States
NeuroScience, Inc.
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Herndon, Virginia, United States
Omega Medical Reserach
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Warwick, Rhode Island, United States
Global Medical Inst LLC; Princeton Medical Institute
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Princeton, New Jersey, United States
Texas Center for Drug Development, Inc.
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Houston, Texas, United States
Summit Research Network (Seattle), LLC
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Seattle, Washington, United States
Clinical Trials Technology, Inc.
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Prairie Village, Kansas, United States
Florida Clinical Research Center, LLC
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Maitland, Florida, United States
Excel Research, Inc.
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Oceanside, California, United States
Miami Research Associates
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South Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
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Orlando, Florida, United States
Rochester Center for Behavioral Medicine
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Rochester Hills, Michigan, United States
Patient Priority Clinical Sites, LLC
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Cincinnati, Ohio, United States
Clinical Trials of America, Inc.
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Eugene, Oregon, United States
Psychiatric Medical Associates
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Plano, Texas, United States
Klinische Forschung Berlin Buch GmbH
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Berlin, Germany
Louisiana Research Associates, Inc.
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New Orleans, Louisiana, United States
Scientella, LLA
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Saint Louis, Missouri, United States
Pharmacology Research Institute
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Newport Beach, California, United States
Activmed Practices and Research
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Haverhill, Massachusetts, United States
Adams Clinical Trials, LLC
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Watertown, Massachusetts, United States
Sunstone Medical Research, LLC
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Medford, Oregon, United States
Oregon Center for Clinical Investigators (OCCI, Inc)
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Portland, Oregon, United States
Robert Lynn Horne, MD, LTD
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Las Vegas, Nevada, United States
Deaconess Clinic Gateway Health Center
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Newburgh, Indiana, United States