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A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents

NCT ID: NCT00447278

Last Updated: 2010-04-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder \[ADHD\]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atomoxetine

0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension

Group Type EXPERIMENTAL

Atomoxetine

Intervention Type DRUG

0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension

OEST

Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

Group Type ACTIVE_COMPARATOR

Other standard therapy for ADHD

Intervention Type DRUG

Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

Interventions

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Atomoxetine

0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension

Intervention Type DRUG

Other standard therapy for ADHD

Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

Intervention Type DRUG

Other Intervention Names

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LY139603 Strattera

Eligibility Criteria

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Inclusion Criteria

* 6 to 16 years old
* Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL)
* Pharmacological naïve
* Normal intelligence as assessed by investigator
* Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.

Exclusion Criteria

* History of bipolar disorder, any history of psychosis or autism spectrum disorder
* History of any seizure disorder
* Significant prior or current medical conditions
* History of alcohol or drug abuse within the past 3 months
* Patients who are taking concurrently any of the excluded medications in the study.
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Brussels, , Belgium

Site Status

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.

Hoboken, , Belgium

Site Status

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.

Leuven, , Belgium

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Amiens, , France

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Bordeaux, , France

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Lyon, , France

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Montpellier, , France

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Paris, , France

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Toulouse, , France

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Tours, , France

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Westside, Galway, Ireland

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Dublin, , Ireland

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Messina, , Italy

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Napoli, , Italy

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S.Vito Tagliamento, , Italy

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San Donà di Piave, , Italy

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Insurgentes Cuicuilco, , Mexico

Site Status

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Mexico City, , Mexico

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Roma Sur, , Mexico

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Bergen, , Norway

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Fredrikstad, , Norway

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Alicante, , Spain

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Barcelona, , Spain

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Donostia / San Sebastian, , Spain

Site Status

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Espluges de Llobregat, , Spain

Site Status

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Palma de Mallorca, , Spain

Site Status

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Pamplona, , Spain

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Sabadell, , Spain

Site Status

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Valencia, , Spain

Site Status

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Adana, , Turkey (Türkiye)

Site Status

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Ankara, , Turkey (Türkiye)

Site Status

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Izmir, , Turkey (Türkiye)

Site Status

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Basildon, Essex, United Kingdom

Site Status

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.

Wigan, Lancashire, United Kingdom

Site Status

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, United Kingdom

Site Status

Countries

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Belgium France Ireland Italy Mexico Norway Spain Turkey (Türkiye) United Kingdom

Other Identifiers

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B4Z-EW-LYDY

Identifier Type: OTHER

Identifier Source: secondary_id

11576

Identifier Type: -

Identifier Source: org_study_id

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