Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

Phase 2 Completed 246 enrolled Shire

RandomizedParallel-groupTriple-blindTreatment

Summary

To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.

Timeline

Start: 2009-07-30
Primary completion: 2010-08-04
Completion: 2010-08-04

Outcome

Met primary endpoint

registry p = 0.0902; Mean Difference (Final Values) -2.3 (90% CI -4.5 to -0.1); ANCOVA NCT00905424 ↗

paper met the prespecified criterion for lisdexamfetamine dimesylate superiority PMID 24021497 ↗

Publications

Results Trivedi MH, Cutler AJ, Richards C, Lasser R, Geibel BB, Gao J, Sambunaris A, Patkar AA. A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram. J Clin Psychiatry. 2013 Aug;74(8):802-9. doi: 10.4088/JCP.13m08360.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lisdexamfetamine	Other / unclassified	20 mg	Oral
Subject	Lisdexamfetamine	Other / unclassified	30 mg	Oral
Subject	Lisdexamfetamine	Other / unclassified	50 mg	Oral
Comparator	Escitalopram	Small molecule	20 mg	Oral