Clinical trial NCT00386581: Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
Official title: Phase III Multicenter, Randomized, Double-Blind Placebo-Controlled Outpatient Study of Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 105
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of atomoxetine administered as a single-daily dose with placebo in Russian children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
Secondary outcomes:
measure: 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
measure: To assess the safety and tolerability of once-daily dosing of atomoxetine in Russian children and adolescents
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.