Clinical trial NCT01291173: Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Binge Eating Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-02-08
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change From Baseline in Log Transformed Binge Days Per Week at Week 11
timeFrame: Baseline and week 11
Secondary outcomes:
measure: Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks
timeFrame: Baseline and up to 11 weeks
measure: 1-Week Binge Response, Last Observation Carried Forward (LOCF)
timeFrame: Last 7 days on study
measure: 4-Week Binge Response
timeFrame: Last 28 days on study
measure: Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
timeFrame: Baseline
measure: Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
timeFrame: up to 11 weeks
measure: Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks
timeFrame: Up to 11 weeks
measure: Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11
timeFrame: Baseline and week 11
measure: Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11
timeFrame: Baseline and week 11
measure: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11
timeFrame: Baseline and week 11
measure: Change From Baseline in Eating Inventory Score at Week 11
timeFrame: Baseline and week 11
measure: Change From Baseline in Binge Eating Scale (BES) Score at Week 11
timeFrame: Baseline and week 11
measure: Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11
timeFrame: Baseline and week 11
measure: Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11
timeFrame: Baseline and week 11
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: Beverly Hills
country: United States
facility: Southwestern Research, Inc.
state: California
city: La Jolla
country: United States
facility: Scripps Clinical Research Services
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: San Diego
country: United States
facility: PCSD - Feighner Research
state: California
city: Bradenton
country: United States
facility: Florida Clinical Research
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine and Research
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Overland Park
country: United States
facility: Vince and Assoc. Research
state: Kansas
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc.
state: Kansas
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc.
state: Louisiana
city: Rockville
country: United States
facility: Marc Hertzman, MD, PC
state: Maryland
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Minneapolis
country: United States
facility: Unniversity of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Weight Disorders Washington University School of Medicine, Dept of Psychiatry
state: Missouri
city: Las Vegas
country: United States
facility: Robert Lynn Horne, MD
state: Nevada
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Fargo
country: United States
facility: Neuropsychiatric Research Institute
state: North Dakota
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Mason
country: United States
facility: Lindner City of Hope
state: Ohio
city: Charleston
country: United States
facility: Weight Management Center, Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials
state: Texas
city: Houston
country: United States
facility: Drug Development, Inc.
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.