Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.

• Status: Completed
• Trial end date: 2005-11-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects the participants sleep and how they perceive their quality of life.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Adderall; Amphetamine; Dextroamphetamine

Criteria

Inclusion Criteria:

• Primary diagnosis of ADHD

• Baseline ADHD-RS-IV score >= 32

• Non-pregnant females of childbearing potential must comply with contraceptive restrictions.

Exclusion Criteria:

• Significantly underweight or morbidly obese

• Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders

• History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder

• Females who are pregnant or lactating