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

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

Timeline

Start

2011-05-10

Primary completion

2012-01-30

Completion

2012-01-30

Outcome

Met primary endpoint

registry analysis (unspecified test); Placebo vs Lisdexamfetamine Dimesylate (SPD489) 50 mg; p = 0.0077; Mean Difference (Final Values) -0.258 (95% CI -0.446 to -0.069); Mixed Models Analysis NCT01291173 ↗

registry analysis (unspecified test); Placebo vs Lisdexamfetamine Dimesylate (SPD489) 70 mg; p = 0.0004; Mean Difference (Final Values) -0.345 (95% CI -0.534 to -0.155); Mixed Models Analysis NCT01291173 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lisdexamfetamine	Other / unclassified	30 mg	—
Subject	Lisdexamfetamine	Other / unclassified	50 mg	—
Subject	Lisdexamfetamine	Other / unclassified	70 mg	—

Indications