Back to resultsAtomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Atomoxetine Hydrochloride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria:
- Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
- Subjects must be aged 6 to 16 years
- Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
- Subjects must be able to swallow capsules
- Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.
Exclusion Criteria:
- Weigh less than 20 kg or more than 60 kg at study entry
- Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
- Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
- Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
- Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
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
Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD
Secondary Outcome Measures
Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo
Compare the reduction in school-related symptoms between atomoxetine and placebo
Assess the safety and tolerability of once-daily dosing of atomoxetine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00485459
Brief Title
Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD
Official Title
Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese 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
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atomoxetine Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD
Secondary Outcome Measure Information:
Title
Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo
Title
Compare the reduction in school-related symptoms between atomoxetine and placebo
Title
Assess the safety and tolerability of once-daily dosing of atomoxetine
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:
Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
Subjects must be aged 6 to 16 years
Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
Subjects must be able to swallow capsules
Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.
Exclusion Criteria:
Weigh less than 20 kg or more than 60 kg at study entry
Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
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
Taipei
Country
Taiwan
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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Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD
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