Back to resultsEfficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
atomoxetine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
Eligibility 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.
Sites / Locations
- 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.
Outcomes
Primary Outcome Measures
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
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
To assess the safety and tolerability of once-daily dosing of atomoxetine in Russian children and adolescents
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00386581
Brief Title
Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
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 Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
atomoxetine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Efficacy of atomoxetine administered as a single-daily dose with placebo in Russian children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
Secondary Outcome Measure Information:
Title
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
Title
To assess the safety and tolerability of once-daily dosing of atomoxetine in Russian children and adolescents
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
25019647
Citation
Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.
Results Reference
derived
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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
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