Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)

NCT00760747 | Completed Phase 4 Results

• 2 other identifiers: 12305B4Z-EW-LYFJ
• Study Type: interventional
• Target: 112
• Locations: 3 countries
• Sites: 6

Brief Summary

Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be compared between the two different switching approaches.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Children; Stimulant; Atomoxetine; Adolescents

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint

  Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.

  Baseline, 10 weeks

• Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint

  Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.

  Baseline, 2 weeks

Secondary Outcomes (10)

• Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint

  Baseline, 10 weeks

• Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint

  Baseline, 10 weeks

• Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint

  Baseline, 10 weeks

• Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint

  Baseline, 10 weeks

• Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint

  Baseline, 10 weeks

Study Arms (2)

Slow Switching Group

EXPERIMENTAL

Slow Switching Group (switch from full stimulant dose to atomoxetine, 1.2 mg/kg/day, orally (PO), during 10 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks

Drug: Atomoxetine

Fast Switching Group

EXPERIMENTAL

Fast Switching Group (switch from full stimulant dose to atomoxetine 1.2 mg/kg/day, PO, during 2 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks

Drug: Atomoxetine

Interventions

Atomoxetine DRUG

1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)

Also known as: LY139603, Strattera

Fast Switching Group; Slow Switching Group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Outpatients between 6-16 years of age
• Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD must be met
• Normal laboratory and electrocardiogram (ECG) results
• Normal intelligence
• Must have unsatisfactory symptom response to stimulant therapy or experience of adverse events while on stimulant therapy

You may not qualify if:

• Less than 20 kg or more than 70 kg at study entry
• Concomitant major psychiatry disorders, drug or alcohol abuse or serious suicide risk
• Medical conditions such as seizures, severe allergies, glaucoma, cardiovascular disease, hypertension, or acute or unstable medical conditions
• Taking of anticonvulsants, antihypertensive agents, medication with sympathomimetic activity, psychotropic medications, monoamine oxidase inhibitor
• Immediate need for stimulant discontinuation due to tolerability problems
• Previous participation in an atomoxetine study, or unresponsive to atomoxetine, or intolerable side effects to atomoxetine

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Milton, Queensland, 4064, Australia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Zona Centro, 37000, Mexico

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Fife, Scotland, KY2 5AH, United Kingdom

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Sheffield, South Yorkshire, S10 5DD, United Kingdom

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Birmingham, West Midlands, B13 8QE, United Kingdom

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.

Northampton, NN1 2BG, United Kingdom

Location

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 26, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 1, 2011
• Results First Posted: September 1, 2011

Record last verified: 2011-08

Locations

ME (1); GB (4); AU (1)