Efficacy and Safety of SPD503 in Combination With Psychostimulants

Summary

The purpose of this study is to assess the efficacy and safety of SPD503 in subjects with ADHD when co-administered with psychostimulants in children and adolescents aged 6-17 years with a diagnosis of ADHD with a sub-optimal, partial response to stimulants.

Timeline

Start

2008-09-02

Primary completion

2009-12-10

Completion

2009-12-10

Publications

• Results Wilens TE, Bukstein O, Brams M, Cutler AJ, Childress A, Rugino T, Lyne A, Grannis K, Youcha S. A controlled trial of extended-release guanfacine and psychostimulants for attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):74-85.e2. doi: 10.1016/j.jaac.2011.10.012. Epub 2011 Nov 25.
• Cutler AJ, Brams M, Bukstein O, Mattingly G, McBurnett K, White C, Rubin J. Response/remission with guanfacine extended-release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2014 Oct;53(10):1092-101. doi: 10.1016/j.jaac.2014.08.001. Epub 2014 Aug 15.

Drugs

Indications