An Open-Label Study of Atomoxetine in Adolescents With Attention-Deficit/Hyperactivity Disorder - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191737

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Atomoxetine	Phase III

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24

Secondary Outcome Measures:

Rosenberg Self-Esteem Scale (SES) during 8 and 24 weeks of treatment
Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment

Estimated Enrollment:	147
Study Start Date:	October 2004
Estimated Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Alcohol or drug abuse within the past 3 months
Are female patients who are pregnant or breast-feeding. Sexually active females must use a medically acceptable method of contraception.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191737

Locations

Germany
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.
Koln, Germany
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.
Freiburg, Germany

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Chair:

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

More Information

Study ID Numbers:	7233, B4Z-SB-LYDE
Study First Received:	September 12, 2005
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00191737
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Atomoxetine

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009