Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes

Lilly

Status and phase

Completed

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Atomoxetine hydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00510276

B4Z-US-LYDZ (Other Identifier)

10803

Details and patient eligibility

About

This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

This study also has an observational community sample arm in which patients will complete all the efficacy measurements via web-based self reporting.

Enrollment

445 patients

Sex

All

Ages

18 to 30 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

positive attention-deficit/hyperactivity disorder (ADHD) diagnosis with at least moderate severity
male or female 18 to 30 years of age
must be able to swallow capsules
must be able to communicate effectively in English
must not have cognitive impairment
be reliable to keep appointments for clinic visits and all related tests

Exclusion criteria

patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, or psychosis
females who are pregnant or breastfeeding
patients with dementia or traumatic brain injury
patients with a history of severe allergy to atomoxetine
have untreated hypertension or thyroid problem
have serious medical illness including any heart, liver, kidney, respiratory, blood, endocrine, or neuromuscular diseases