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

Study Overview
=================
Brief 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.

Official Title
-----------------
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
-----------------
Attention Deficit Disorder With Hyperactivity

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


Participation Criteria
=================
Eligibility 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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) | The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54. | Baseline (following ADHD medication washout of 7-28 days) | 
| The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) | The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54. | Week 1 | 
| The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) | The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54. | Week 2 | 
| The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) | The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54. | Week 3 | 
| The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) | The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54. | Week 4 | 
| The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) | The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54. | Week 5 | 
| The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) | The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54. | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET) |  | Weeks 1, 2, 3, 4, 5, & 6 | 
| Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits |  | Baseline visit and weeks 1, 2, 3, 4, 5, & 6 | 
| Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits. |  | Baseline visit and weeks 1, 2, 3, 4, 5, & 6 | 
| Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion. |  | Baseline visit and weeks 1, 2, 3, 4, 5, & 6 |