Back to resultsAn Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity Disorder
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Atomoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria: Male or female outpatients who are at least 12 years of age and who will not have reached their 18th birthday Diagnosis of ADHD Normal intelligence Exclusion Criteria: Weigh less than 30 kg or more than 85 kg at study entry Other relevant psychiatric diagnoses Are at serious suicidal risk as determined by the investigator Have a history of severe allergies Alcohol or drug abuse within the past 3 months Are female patients who are pregnant or breast-feeding. Sexually active females must use a medically acceptable method of contraception.
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.
- 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
Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
Secondary Outcome Measures
Rosenberg Self-Esteem Scale (SES) during 8 and 24 weeks of treatment
Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment
Full Information
NCT ID
NCT00191737
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00191737
Brief Title
An Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity Disorder
Official Title
An Open-Label Study on Effectiveness and Tolerability of Atomoxetine, as Perceived by Patients, Parents, and Physicians in Adolescents With Attention-Deficit/Hyperactivity Disorder in Germany
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on self-esteem in adolescents (aged 12 through 17 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
147 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Primary Outcome Measure Information:
Title
Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
Secondary Outcome Measure Information:
Title
Rosenberg Self-Esteem Scale (SES) during 8 and 24 weeks of treatment
Title
Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female outpatients who are at least 12 years of age and who will not have reached their 18th birthday
Diagnosis of ADHD
Normal intelligence
Exclusion Criteria:
Weigh less than 30 kg or more than 85 kg at study entry
Other relevant psychiatric diagnoses
Are at serious suicidal risk as determined by the investigator
Have a history of severe allergies
Alcohol or drug abuse within the past 3 months
Are female patients who are pregnant or breast-feeding. Sexually active females must use a medically acceptable method of contraception.
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 Chair
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
Freiburg
Country
Germany
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
Koln
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21432592
Citation
Wehmeier PM, Schacht A, Dittmann RW, Banaschewski T. Minor differences in ADHD-related difficulties between boys and girls treated with atomoxetine for attention-deficit/hyperactivity disorder. Atten Defic Hyperact Disord. 2010 Jun;2(2):73-85. doi: 10.1007/s12402-010-0022-2. Epub 2010 Mar 30.
Results Reference
derived
PubMed Identifier
19703299
Citation
Dittmann RW, Wehmeier PM, Schacht A, Minarzyk A, Lehmann M, Sevecke K, Lehmkuhl G. Atomoxetine treatment and ADHD-related difficulties as assessed by adolescent patients, their parents and physicians. Child Adolesc Psychiatry Ment Health. 2009 Aug 24;3(1):21. doi: 10.1186/1753-2000-3-21.
Results Reference
derived
Learn more about this trial
An Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity Disorder
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