Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD

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)

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Atomoxetine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

• Lilly Clinical Trial Registry

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Study Completion (Actual): January 1, 2005

Study Registration Dates

• First Submitted: June 11, 2007
• First Submitted That Met QC Criteria: June 11, 2007
• First Posted (Estimate): June 13, 2007

Study Record Updates

• Last Update Posted (Estimate): June 13, 2007
• Last Update Submitted That Met QC Criteria: June 11, 2007
• Last Verified: June 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Atomoxetine Hydrochloride
• Other Study ID Numbers: 7953; B4Z-MC-LYCI