A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Lilly

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: atomoxetine hydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00700427

9655

B4Z-MC-LYDO (Other Identifier)

Details and patient eligibility

About

LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).

Enrollment

2,017 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults
Male or female
Must meet Attention-Deficit/Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision™ (DSM-IV-TR™) criteria

Exclusion criteria

Comorbidity with major psychiatric disorder
Clinically significant depression or anxiety
Patients with significant medical conditions
Current alcohol/drugs abuse/dependence
Concomitant excluded medications

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

2,017 participants in 2 patient groups, including a placebo group

Atomoxetine

Experimental group

Description:

Atomoxetine 40-100 milligrams per day (mg/day) orally, once daily or twice daily for 24 weeks, followed by atomoxetine 80-100 mg/day orally, once daily or twice daily for 25 weeks.

Treatment:

Drug: atomoxetine hydrochloride

Placebo

Placebo Comparator group

Description:

Atomoxetine 40-100 mg/day orally, once daily or twice daily for 24 weeks, followed by placebo orally, once daily for 25 weeks.

Treatment:

Drug: Placebo

Drug: atomoxetine hydrochloride