Back to resultsSafety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria:
- Patients must be at least 6 years of age and not yet be 18 years of age at the completion of visit 6
- Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype)
- Patients must have laboratory results showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)
- Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on a IQ test)
- Patients must be able to swallow capsules
Exclusion Criteria:
- Patients who weigh less than 22 kg or more than 70 kg at study entry
- Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or a pervasive developmental disorder
- Patients with a history of any seizure disorder (other than febrile seizures) or prior EEG abnormalities related to epilepsy, or patients who have taken (or are currently taking) anticonvulsants for seizure control
- Patients with a history of severe allergies to more than one class of medication, or multiple adverse drug reactions
- Patients who have glaucoma
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-582-4559, 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
Assess the change in ADHD symptoms when switching from stimulant medication to atomoxetine among patients who cannot tolerate or do not respond to stimulants and require a medication change
Secondary Outcome Measures
Assess whether there are statistically significant differences in ADHD symptom measures after a patient changes from a stimulant medication to atomoxetine
Assess the safety and tolerability of atomoxetine alone compared with stimulant medications alone and during the time of switch (stimulant plus atomoxetine) as assessed by AEs elicited during open-ended questioning.
Compare atomoxetine and stimulant medications on other secondary measures, including parent preference
Assess whether there is a significant change in problem behaviors related to ADHD after switching from stimulant medication to atomoxetine
Assess the change in inattentive and hyperactive symptoms among these same patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00485875
Brief Title
Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD
Official Title
An Open-Label, Multicenter, Pilot Study of the Safety and Efficacy of Transitioning From a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess changes in ADHD symptoms and tolerability of medication in children and adolescents switching from a stimulant to atomoxetine.
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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atomoxetine Hydrochloride
Primary Outcome Measure Information:
Title
Assess the change in ADHD symptoms when switching from stimulant medication to atomoxetine among patients who cannot tolerate or do not respond to stimulants and require a medication change
Secondary Outcome Measure Information:
Title
Assess whether there are statistically significant differences in ADHD symptom measures after a patient changes from a stimulant medication to atomoxetine
Title
Assess the safety and tolerability of atomoxetine alone compared with stimulant medications alone and during the time of switch (stimulant plus atomoxetine) as assessed by AEs elicited during open-ended questioning.
Title
Compare atomoxetine and stimulant medications on other secondary measures, including parent preference
Title
Assess whether there is a significant change in problem behaviors related to ADHD after switching from stimulant medication to atomoxetine
Title
Assess the change in inattentive and hyperactive symptoms among these same patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be at least 6 years of age and not yet be 18 years of age at the completion of visit 6
Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype)
Patients must have laboratory results showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)
Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on a IQ test)
Patients must be able to swallow capsules
Exclusion Criteria:
Patients who weigh less than 22 kg or more than 70 kg at study entry
Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or a pervasive developmental disorder
Patients with a history of any seizure disorder (other than febrile seizures) or prior EEG abnormalities related to epilepsy, or patients who have taken (or are currently taking) anticonvulsants for seizure control
Patients with a history of severe allergies to more than one class of medication, or multiple adverse drug reactions
Patients who have glaucoma
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 (1-877-582-4559, 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
St. Louis
State/Province
Missouri
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD
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