A Phase II, Randomized, Double-Blind, Multi-center, Placebo-controlled, Crossover Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Shire4 sites in 1 country72 target enrollmentSeptember 29, 2005

ConditionsAttention Deficit Disorder With Hyperactivity

DrugsNeutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: Shire
Enrollment: 72
Locations: 4
Primary Endpoint: PERMP (Permanent Product Measure of Performance)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate how safe and how well SPD465 works compared to placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration of clinical benefit.

Registry

clinicaltrials.gov

Start Date

September 29, 2005

End Date

January 6, 2006

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Primary diagnosis of ADHD using DSM-IV-TR criteria (at least 6 of the 9 subtype criteria met)
•Baseline ADHD-RS-IV score =\>24
•IQ score of =\> 80 (using Kaufman Brief Intelligence Test)

Exclusion Criteria

•BMI \< 18.5 or \> 30 kg/m2
•Diagnosis of Post Traumatic Stress Disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
•History of seizure disorder or a lifetime history of any seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
•History of uncontrolled hypertension or currently hypertensive
•Subjects who have taken atomoxetine (STRATTERA) within 30 days prior to screening
•Current (or history within the last 12 months) of drug dependence or substance abuse disorder according to DSM-IV-TR criteria (excluding nicotine)
•Female subject is pregnant or lactating, less than 3 months post partum

Outcomes

Primary Outcomes

PERMP (Permanent Product Measure of Performance)

Time Frame: 16 hours post-dosing

Secondary Outcomes

Subject self report (ADHD-SRS) of ADHD(approximately 5½, 11, and 16½ hours post-dosing)
Treatment emergent adverse events(Throughout the study period of approximately 3.25 months.)
Modified Pittsburgh Sleep Quality Index (PSQI)(Study orientation and randomization visit, Week 1 after Study orientation and randomization visit, Week 2 after Study orientation and randomization visit)
Time Segment Rating System (ADHD-RS[TSRS])(5½, 11, and 16½ hours post-dosing)