Safety and Efficacy of SPD465 in Adults With ADHD
Phase 2
Completed
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Registration Number
- NCT00202605
- Lead Sponsor
- Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method PERMP (Permanent Product Measure of Performance) 16 hours post-dosing
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Clinical Study Center
🇺🇸Little Rock, Arkansas, United States
UCI Child Development Center
🇺🇸Irvine, California, United States
Center for Psychiatry and Behavioral Medicine, Inc.
🇺🇸Las Vegas, Nevada, United States
Bayou City Research, Ltd.
🇺🇸Houston, Texas, United States