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.

Condition	Intervention	Phase
Attention Deficit Disorder with Hyperactivity.	Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.	Phase III

Further Study Details: 

Primary Outcomes: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) taken at the Baseline visit and all visits thereafter.
Secondary Outcomes: Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET); Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits; Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.; Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.
Expected Total Enrollment:  412

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

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

Study ID Numbers:  SPD465-303
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00152022
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13