Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-06-30

Brief Summary

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The purpose of this study is to evaluate the change in neuropsychological status from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.

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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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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

1. Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 10 years 6 months of age at Visit 1 so that all testing will be completed before the child reaches age 11.
2. Patients must have moderately severe symptoms of ADHD.
3. Patients must be able to swallow study drug capsules.

1\) Control subjects must be assessed to be not diagnosed with a psychiatric disorder or a medically significant disorder

Exclusion Criteria

1. Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
2. Patients must not be home-schooled.

B) Controls:

Subjects will be recruited by the investigator, age and gender-matched to the atomoxetine-treated patients.

1\) Subjects must not be home-schooled.

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No