Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents 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

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-02-28

Brief Summary

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The study is designed to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week acute treatment period and a 2-week discontinuation phase. The assessments in this study include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.

Detailed Description

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Conditions

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Attention Deficit Disorder With Hyperactivity

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

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have ADHD that meets the DSM-IV criteria
* Aged 6 to 16 years.
* Subjects must not have taken any medication used to treat ADHD.
* Laboratory results must show no significant abnormalities
* Baseline ECG results must not show an abnormality
* Subjects must be able to swallow capsules.
* Subjects must be of normal intelligence.

Exclusion Criteria

* Weigh less than 20 kg or more than 60 kg at study entry.
* Subjects who, after an adequate trial with methylphenidate or amphetamine experience some benefit in ADHD signs and symptoms are excluded from participating.
* Have a history of Bipolar I or II disorder, psychosis, or PDD.
* Meet DSM-IV criteria for an anxiety disorder.
* Have a history of any seizure disorder.
* Patients at serious suicidal risk.
* Patients with narrow angle glaucoma
* Subjects who have a history of severe allergies .
* Have a history of alcohol or drug abuse within the past 3 months
* Screen positive for drugs of abuse not prescribed by a physician.
* Have cardiovascular disease and an increased heart rate and blood pressure.
* Have a medical condition that would increase sympathetic nervous system activity markedly or who are taking a medication on a daily basis.
* Have severe gastrointestinal narrowing
* Are during the study time likely to need psychotropic medications.
* Are likely to begin a structured psychotherapy aimed at ADHD symptoms.
* Have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks
* Female subjects who are pregnant or who are breast-feeding.
* Are investigative site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
* Are, in the opinion of the investigator, unsuitable in any other way to participate in this study.
* Are employed by Lilly.

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.

Moscow, , Russia

Site Status

Countries

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Russia

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-MW-LYCZ

Identifier Type: -

Identifier Source: secondary_id

9081