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

Attention Deficit Hyperactivity Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485875
• Other study ID #: 7953
• Secondary ID: B4Z-MC-LYCI
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2007
• Last updated: June 11, 2007
• Start date: June 2004
• Est. completion date: January 2005

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Atomoxetine Hydrochloride

Locations

Country	Name	City	State
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.	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assess whether there are statistically significant differences in ADHD symptom measures after a patient changes from a stimulant medication to atomoxetine
Secondary	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.
Secondary	Compare atomoxetine and stimulant medications on other secondary measures, including parent preference
Secondary	Assess whether there is a significant change in problem behaviors related to ADHD after switching from stimulant medication to atomoxetine
Secondary	Assess the change in inattentive and hyperactive symptoms among these same patients

External Links

•   Lilly Clinical Trial Registry