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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Phase III Multicenter, Randomized, Double-Blind Placebo-Controlled Outpatient Study of Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386581
• Other study ID #: 9081
• Secondary ID: B4Z-MW-LYCZ
• Status: Completed
• Phase: Phase 3
• First received: October 6, 2006
• Last updated: June 11, 2007
• Start date: July 2004
• Est. completion date: February 2005

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• atomoxetine

• placebo

Locations

Country	Name	City	State
Russian Federation	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of atomoxetine administered as a single-daily dose with placebo in Russian children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
Secondary	To compare improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo, defined by a more than 25% reduction in the ADHDRS-IV-Parent:Inv total score and by mean reductions in Conners
Secondary	To assess the safety and tolerability of once-daily dosing of atomoxetine in Russian children and adolescents

External Links

•   Lilly Clinical Trial Registry