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

NCT00191737 | Completed Phase 3

• 2 other identifiers: 7233B4Z-SB-LYDE
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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

Interventions

Atomoxetine DRUG

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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, Germany

Location

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 im Breisgau, Germany

Location

Related Publications (2)

• Wehmeier PM, Schacht A, Dittmann RW, Banaschewski T. Minor differences in ADHD-related difficulties between boys and girls treated with atomoxetine for attention-deficit/hyperactivity disorder. Atten Defic Hyperact Disord. 2010 Jun;2(2):73-85. doi: 10.1007/s12402-010-0022-2. Epub 2010 Mar 30.

  PMID: 21432592 DERIVED

• Dittmann RW, Wehmeier PM, Schacht A, Minarzyk A, Lehmann M, Sevecke K, Lehmkuhl G. Atomoxetine treatment and ADHD-related difficulties as assessed by adolescent patients, their parents and physicians. Child Adolesc Psychiatry Ment Health. 2009 Aug 24;3(1):21. doi: 10.1186/1753-2000-3-21.

  PMID: 19703299 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2004
• Study Completion: February 1, 2006
• Last Updated: January 26, 2007

Record last verified: 2007-01

Locations

DE (2)