Safety and Efficacy of SPD465 in Adults With ADHD

Completed · Phase 2

Conditions studied: Attention Deficit Disorder With Hyperactivity

In brief

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.

Key facts

Study ID

NCT00202605

Run by

Shire

People needed

72

Starts

2005-09-29

Expected to finish

2006-01-06

Last updated by the study team

2021-06-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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