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

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride

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.