NCT00386581

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
Last Updated

June 12, 2007

Status Verified

June 1, 2007

First QC Date

October 6, 2006

Last Update Submit

June 11, 2007

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

  • Efficacy of atomoxetine administered as a single-daily dose with placebo in Russian children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

Secondary Outcomes (2)

  • To compare improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo, defined by a more than 25% reduction in the ADHDRS-IV-Parent:Inv total score and by mean reductions in Conners

  • To assess the safety and tolerability of once-daily dosing of atomoxetine in Russian children and adolescents

Interventions

atomoxetineDRUG
placeboDRUG

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

Related Publications (1)

  • 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.

    PMID: 25019647DERIVED

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 6, 2006

First Posted

October 11, 2006

Study Start

July 1, 2004

Study Completion

February 1, 2005

Last Updated

June 12, 2007

Record last verified: 2007-06

Locations

RU(1)