Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Summary

The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.

Timeline

Start

2010-05-19

Primary completion

2010-11-29

Completion

2010-11-29

Publications

• Results Adler LA, Dirks B, Deas PF, Raychaudhuri A, Dauphin MR, Lasser RA, Weisler RH. Lisdexamfetamine dimesylate in adults with attention-deficit/ hyperactivity disorder who report clinically significant impairment in executive function: results from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2013 Jul;74(7):694-702. doi: 10.4088/JCP.12m08144.
• Brown TE, Chen J, Robertson B. Relationships Between Executive Function Improvement and ADHD Symptom Improvement With Lisdexamfetamine Dimesylate in Adults With ADHD and Executive Function Deficits: A Post Hoc Analysis. Prim Care Companion CNS Disord. 2020 May 28;22(3):19m02559. doi: 10.4088/PCC.19m02559.
• Adler LA, Dirks B, Deas P, Raychaudhuri A, Dauphin M, Saylor K, Weisler R. Self-Reported quality of life in adults with attention-deficit/hyperactivity disorder and executive function impairment treated with lisdexamfetamine dimesylate: a randomized, double-blind, multicenter, placebo-controlled, parallel-group study. BMC Psychiatry. 2013 Oct 9;13:253. doi: 10.1186/1471-244X-13-253.

Drugs

Indications