Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Randomised, Controlled, Open-Label Study of the Broader Efficacy of Atomoxetine Hydrochloride in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191659
• Other study ID #: 6962
• Secondary ID: B4Z-BP-LYBS
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: February 28, 2007
• Start date: June 2004
• Est. completion date: April 2006

Study information

• Verified date: February 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine hydrochloride in comparison to standard current therapies have greater improvements in their quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

Inclusion Criteria:

• Diagnosis of ADHD

Exclusion Criteria:

• Patients who weigh less than 20kg at visit 1

• Have Bipolar Disorder/seizure disorder/taken anticonvulsants for seizures

• Judged to be at suicidal risk

• Taking psychotropic medication on a regular basis

• Hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel 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 Kingdom	For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.	Basingstoke	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test whether atomoxetine given for 10 weeks is superior to standard current therapy as measured by CHIP-CE (Child Health and Illness Profile - Child Edition)
Secondary	CHIP-CE total mean score after 4 weeks of treatment.
Secondary	The domains of the CHIP-CE after 4 and 10 weeks of treatment.
Secondary	The following are measured after both 4 and 10 weeks of treatment:
Secondary	Family Buden of Illness
Secondary	Harter Self Perception Profile
Secondary	ADHD-RS
Secondary	Clinical Global Impression- Severity
Secondary	Clinical Global Impression -Improvement
Secondary	To assess whether changes to the above scales are maintained over long term
Secondary	Long-term safety of atomoxetine

External Links

•   Lilly Clinical Trial Registry