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 sleep and how the participants perceive their quality of life.

Condition	Intervention	Phase
Attention Deficit Disorder with Hyperactivity	Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, 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 (CGI-I) - assessed at visits A1 through A7/Early Termination (ET); Time-Sensitive ADHD Symptom Scale (TASS) - completed at the Baseline visit and twice daily throughout the remainder of the subjects participation in this study; Brown ADD Scale (BADDS) - completed at the Baseline and A7/ET visits; Adult ADHD Impact Module (AIM-A) - completed at the Baseline and A7/ET visits; Pittsburgh Sleep Quality Index (PSQI) - completed at every visit from Baseline to study completion/ET
Expected Total Enrollment:  240

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 >= 24
• 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

Study ID Numbers:  SPD465-301
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150579
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13