Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD

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

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2004-11-30

Brief Summary

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The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.

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

DOUBLE

Interventions

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Atomoxetine Hydrochloride

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
* Subjects must be aged 6 to 16 years
* Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
* Subjects must be able to swallow capsules
* Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.

Exclusion Criteria

* Weigh less than 20 kg or more than 60 kg at study entry
* Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
* Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
* Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
* Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.

Reference Type DERIVED

PMID: 25019647 (View on PubMed)

Other Identifiers

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B4Z-TW-S010

Identifier Type: -

Identifier Source: secondary_id

8160