Completed

An Open-Label Study on Effectiveness and Tolerability of Atomoxetine, as Perceived by Patients, Parents, and Physicians in Adolescents With Attention-Deficit/Hyperactivity Disorder in Germany

What is being tested

Data Collection

Who is being recruted

Attention Deficit Disorder with Hyperactivity+1

+ Mental Disorders

+ Attention Deficit and Disruptive Behavior Disorders

From 12 to 17 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: October 2004

See protocol details

Summary

Principal SponsorEli Lilly and Company

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2004

Actual date on which the first participant was enrolled.

A single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on self-esteem in adolescents (aged 12 through 17 years) with Attention-Deficit/Hyperactivity Disorder treated as outpatients in Germany. An 8-week treatment phase is followed by a 16-week extension period.

Official TitleAn Open-Label Study on Effectiveness and Tolerability of Atomoxetine, as Perceived by Patients, Parents, and Physicians in Adolescents With Attention-Deficit/Hyperactivity Disorder in Germany

NCT00191737

Principal SponsorEli Lilly and Company

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

147 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Attention Deficit Disorder with HyperactivityMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Criteria

3 inclusion criteria required to participate

Male or female outpatients who are at least 12 years of age and who will not have reached their 18th birthday

Diagnosis of ADHD

Normal intelligence

6 exclusion criteria prevent from participating

Weigh less than 30 kg or more than 85 kg at study entry

Other relevant psychiatric diagnoses

Are at serious suicidal risk as determined by the investigator

Have a history of severe allergies

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

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.

Cologne, GermanyOpen 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. in Google Maps

Suspended

Freiburg im Breisgau, Germany

Completed2 Study Centers