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

NCT00485875 | Completed Phase 4

• 2 other identifiers: 7953B4Z-MC-LYCI
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Interventions

Atomoxetine Hydrochloride DRUG

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: June 1, 2004
• Study Completion: January 1, 2005
• Last Updated: June 13, 2007

Record last verified: 2007-06

Locations

US (1)