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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00386581
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : June 12, 2007
Information provided by:
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: atomoxetine Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : July 2004
Actual Study Completion Date : February 2005

Primary Outcome Measures :
  1. Efficacy of atomoxetine administered as a single-daily dose with placebo in Russian children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

Secondary Outcome Measures :
  1. 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
  2. To assess the safety and tolerability of once-daily dosing of atomoxetine in Russian children and adolescents

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00386581

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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, Russian Federation
Sponsors and Collaborators
Eli Lilly and Company
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00386581    
Other Study ID Numbers: 9081
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: June 12, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs