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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-04-30

Brief Summary

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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.

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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

Interventions

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Atomoxetine Hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No