Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Atomoxetine Hydrochloride (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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), Study Director, Affiliation: Eli Lilly and Company
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.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: Assess whether there are statistically significant differences in ADHD symptom measures after a patient changes from a stimulant medication to atomoxetineAssess 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
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
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., St. Louis, Missouri, United States
Additional Information
Lilly Clinical Trial Registry
Starting date: June 2004
Last updated: June 11, 2007
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