Efficacy and Safety of SPD465 in Adults With ADHD

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III, Randomized, Double-blind, Multi-center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. | The Endpoint is the average of the values obtained at Weeks 5, 6, and 7. | Baseline, and the Endpoint (average of weeks 5, 6, 7). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment. | The Endpoint is the average of the values obtained at Weeks 5, 6, and 7. | Baseline, and the Endpoint (average of weeks 5, 6, 7). | 
| Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment. | The Endpoint is the average of the values obtained at Weeks 5, 6, and 7. | Baseline, and the Endpoint (average of weeks 5, 6, 7). | 
| Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment | The Endpoint is the average of the values obtained at Weeks 5, 6, and 7. | Baseline, and the Endpoint (average of weeks 5, 6, 7). | 
| Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment | The Endpoint is the average of the values obtained at Weeks 5, 6, and 7. | Baseline, and the Endpoint (average of weeks 5, 6, 7). | 
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1 |  | Baseline and Week 1. | 
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4 |  | Baseline and Week 4. | 
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7 |  | Baseline and Week 7. |