Safety and Efficacy of SPD465 in Adults With ADHD

Shire

Status and phase

Completed

Phase 2

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Drug: Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00202605

SPD465-203

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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