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

NCT ID: NCT00191737

Last Updated: 2007-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2006-02-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Atomoxetine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Principal Investigators

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_CHAIR

Eli Lilly and Company

Locations

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

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

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 21432592 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19703299 (View on PubMed)

Other Identifiers

B4Z-SB-LYDE

Identifier Type: -

Identifier Source: secondary_id

7233

Identifier Type: -

Identifier Source: org_study_id