The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Phase 2
Completed
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Interventions
- Registration Number
- NCT00928148
- Lead Sponsor
- Shire
- Brief Summary
This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg) compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults with ADHD. The controlled environment used in this study is an analog classroom setting adapted for a 16-hour adult day.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
Inclusion Criteria
- Adult men and non-pregnant women between the ages of 18 and 55
- Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Baseline ADHD score of at least 24
Exclusion Criteria
- Weight less than 100 pounds or greater than 250 pounds
- Psychiatric diagnosis such as a severe comorbid Axis II or Axis I disorder
- Pregnancy or breastfeeding
- History of seizures
- Positive urine drug screen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Immediate Release Amphetamine salt (25 mg) Immediate Release Amphetamine Salt - Placebo Placebo - SPD465 (50 or 75 mg) SPD465 -
- Primary Outcome Measures
Name Time Method To assess the duration of efficacy of SPD465 compared to placebo and immediate release amphetamine formulation in adults with ADHD using the Permanent Product Measure of Performance (PERMP) math test -0.5, 2, 4, 8, 12, 14 and 18 hours post-dose
- Secondary Outcome Measures
Name Time Method To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the ADHD-rating scale (ADHD-RS) 5, 10 and 15 hours post-dose To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the Swanson, Kotkin, Agler, M. Flynn, and Pelham (SKAMP) scale 5, 10, and 15 hours post-dose To assess the impact of SPD465 compared with placebo and immediate release amphetamine on sleep as measured by the modified Pittsburgh Sleep Quality Index (PSQI) 21 days To evaluate the safety of SPD465 based on occurrence of treatment-emergent adverse events (TEAEs), blood pressure (BP), heart rate, electrocardiogram (ECG), and clinical laboratory findings 21 days