Efficacy and Safety of SPD465 in Adults With ADHD

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Shire

Status and phase

Completed
Phase 3

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150579
SPD465-301

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects sleep and how the participants perceive their quality of life.

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Primary diagnosis of ADHD * Baseline ADHD-RS-IV score \>= 24 * Non-pregnant females of childbearing potential must comply with contraceptive restrictions

Exclusion criteria

* Significantly underweight or morbidly obese * Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders * History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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