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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191737
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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.
Freiburg, 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
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

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013