A Phase IIIb Study to Evaluate the Efficacy and Time Course of Treatment With SPD465 Compared to Placebo on Simulated Driving Safety and Performance in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Shire1 site in 1 countryApril 30, 2007

ConditionsAttention Deficit Hyperactivity Disorder

InterventionsPlacebo SPD465

DrugsSPD465

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Shire
Locations: 1
Primary Endpoint: Simulated Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit.
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether SPD465 is safe and effective in the treatment of ADHD in young adult drivers after a duration of 16 hours.

Registry

clinicaltrials.gov

Start Date

April 30, 2007

End Date

June 15, 2007

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must have a valid driver's license with a minimum of 3 years of driving experience.
•Subject reports daily driving activity.
•Subject is fluent in English.
•Subject must be male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.
•Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities
•Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria
•Exclusion criteria:
•Subject is significantly underweight or morbidly obese.
•Subject has a controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations that, in the opinion of the examining Physician, will contraindicate SPD465 treatment or confound efficacy or safety assessments.
•Subject with a lifetime history of psychosis or bipolar disorder.

Exclusion Criteria

Not provided

Arms & Interventions

Placebo then SPD465

Intervention: Placebo

SPD465 then Placebo

Intervention: SPD465

SPD465 then Placebo

Intervention: Placebo

Placebo then SPD465

Intervention: SPD465

Outcomes

Primary Outcomes

Simulated Driver Safety (DS) Score averaged over 3 driving assessments at one interim and one final visit.

Time Frame: Interim visit = Week 3; Final visit = Week 7.

Secondary Outcomes

Interim & final visits: Clinical Global Impressions of Improvement (CGI-I)(Interim visit = Week 3; Final visit = Week 7.)
Interim & final visits: Self-Rating of Simulated Driver Safety (DS) Performance Questionnaire(Post DS Testing - Interim visit = Week 3; Post DS Testing - Final visit = Week 7.)
Interim & final visits: Attention-Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV)(Interim visit = Week 3; Final visit = Week 7.)