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NCT00510276 · ClinicalTrials.gov registry record · Phase 4
Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes
A Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 445
- Enrollment target
- 20
- Study locations
NCT00510276: Completed Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by Eli Lilly and Company.
NCT00510276 is a Phase 4 study of Attention Deficit Hyperactivity Disorder that has completed, run by Eli Lilly and Company. The registered enrollment target is 445 participants, above the 212-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (110% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00510276, a Phase 4 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 445 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults. A gatekeeper strategy will be employed for sequentially testing the secondary objectives. This study also has an observational community sample arm in which patients will complete all the efficacy measurements via web-based self reporting.
Primary Outcome
CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Atomoxetine hydrochloride
Study Locations (20)
California
- 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. - Los Angeles
- 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. - Rolling Hills Est.
- 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. - Spring Valley
- 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. - Wildomar
Florida
- 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. - Gainesville
- 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. - Jacksonville
- 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. - South Miami
- 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. - St. Petersburg
Ohio
- 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. - Beachwood
- 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. - Cincinnati
Idaho
- 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. - Eagle
Kansas
- 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. - Topeka
Kentucky
- 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. - Lexington
Massachusetts
- 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. - Belmont
Michigan
- 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. - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 445 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-02 |
| Phase | Phase 4 |
What the finished NCT00510276 record still lists
NCT00510276 is an interventional study that assigns participants to a tested intervention. The registered 445 participants enrollment target is mid-sized for trials with a published cap, above the 212-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (110% higher).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00510276 names 20 study sites across 13 states, led by California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT00510276 about?
NCT00510276 is a clinical study titled "Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes". This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults. A gatekeeper strategy will be employed for sequentially testing the secondary objectives. This study also has an obs...
What is the current status of trial NCT00510276?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 445 participants. The study started on 2007-08. Estimated completion is 2009-02.
What conditions does trial NCT00510276 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT00510276?
The interventions under investigation include: Placebo (DRUG), Atomoxetine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00510276?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00510276 being conducted?
This trial has 20 study locations across California, Florida, Idaho, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00510276's enrollment target sits among peer trials
445 11th of 102 higher than 92 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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