ClinicalTrials.gg
CompletedNCT00191737Updated Jan 26, 2007

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

A Phase 3 interventional study of Atomoxetine in Attention Deficit Hyperactivity Disorder, sponsored by Eli Lilly and Company. Completed at 2 sites in Germany. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2007-01-26.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
147
Allocation
Non-randomized
Ages
12 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
03

In context

Attention Deficit Disorder with Hyperactivity

1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.

This study's enrollment of 147 is above the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
147 participants

Interventions

06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Rosenberg Self-Esteem Scale (SES) during 8 and 24 weeks of treatment

  2. Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment

07

Study locations

2 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 21432592 ↗
  • 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. PubMed 19703299 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2004 and a completion of Feb 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2005
First posted
Sep 19, 2005
Start
Oct 2004
Completion
Feb 2006
Last update
Jan 26, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Jan 26, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00191737
First posted
Sep 19, 2005
Start date
Oct 2004
Completion
Feb 2006
Last update
Jan 26, 2007

Study contacts

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)
study chair · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Atomoxetine

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