Status:
COMPLETED
Safety and Efficacy of SPD465 in Adults With ADHD
Lead Sponsor:
Shire
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2005
Trial Type :
INTERVENTIONAL
End Date :
January 6 2006
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00202605
Start Date
September 29 2005
End Date
January 6 2006
Last Update
June 24 2021
Active Locations (4)
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1
Clinical Study Center
Little Rock, Arkansas, United States
2
UCI Child Development Center
Irvine, California, United States
3
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States
4
Bayou City Research, Ltd.
Houston, Texas, United States