Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

Lilly

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Drug: atomoxetine

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00386581

B4Z-MW-LYCZ

9081

Details and patient eligibility

About

The study is designed to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week acute treatment period and a 2-week discontinuation phase. The assessments in this study include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.

Enrollment

105 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Subjects must have ADHD that meets the DSM-IV criteria
Aged 6 to 16 years.
Subjects must not have taken any medication used to treat ADHD.
Laboratory results must show no significant abnormalities
Baseline ECG results must not show an abnormality
Subjects must be able to swallow capsules.
Subjects must be of normal intelligence.

Exclusion Criteria

Weigh less than 20 kg or more than 60 kg at study entry.
Subjects who, after an adequate trial with methylphenidate or amphetamine experience some benefit in ADHD signs and symptoms are excluded from participating.
Have a history of Bipolar I or II disorder, psychosis, or PDD.
Meet DSM-IV criteria for an anxiety disorder.
Have a history of any seizure disorder.
Patients at serious suicidal risk.
Patients with narrow angle glaucoma
Subjects who have a history of severe allergies .
Have a history of alcohol or drug abuse within the past 3 months
Screen positive for drugs of abuse not prescribed by a physician.
Have cardiovascular disease and an increased heart rate and blood pressure.
Have a medical condition that would increase sympathetic nervous system activity markedly or who are taking a medication on a daily basis.
Have severe gastrointestinal narrowing
Are during the study time likely to need psychotropic medications.
Are likely to begin a structured psychotherapy aimed at ADHD symptoms.
Have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks
Female subjects who are pregnant or who are breast-feeding.
Are investigative site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
Are, in the opinion of the investigator, unsuitable in any other way to participate in this study.
Are employed by Lilly.