Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01226511 · ClinicalTrials.gov registry record · Phase 3
A Study in Pediatric Participants With Generalized Anxiety Disorder
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 281
- Enrollment target
NCT01226511: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01226511 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 281 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01226511, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 281 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if duloxetine \[30-120 milligrams (mg)\] given once a day by mouth for 10 weeks to children and adolescents, is better than placebo when treating Generalized Anxiety Disorder (GAD).
Primary Outcome
PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated
Interventions
- DRUG Placebo
- DRUG Duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT01226511 record still lists
NCT01226511 is an interventional study that assigns participants to a tested intervention. The registered 281 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01226511 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01226511 about?
NCT01226511 is a clinical study titled "A Study in Pediatric Participants With Generalized Anxiety Disorder". The purpose of this study is to find out if duloxetine \[30-120 milligrams (mg)\] given once a day by mouth for 10 weeks to children and adolescents, is better than placebo when treating Generalized Anxiety Disorder (GAD).
What is the current status of trial NCT01226511?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 281 participants. The study started on 2011-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01226511?
The interventions under investigation include: Placebo (DRUG), Duloxetine (DRUG).
Who is sponsoring clinical trial NCT01226511?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01226511's enrollment target sits among peer trials
281 1194th of 2000 higher than 806 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04521231 · 281 participants · Phase 1
A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
- NCT06190730 · 281 participants · NA
REmote Symptom COllection to improVE postopeRative Care
- NCT02860364 · 282 participants · NA
Comparing Hypothermic Temperatures During Hemiarch Surgery
- NCT04867395 · 282 participants · NA
A Multi-Phase Study Examining Hospital to Home Transitions for Children With Medical Complexity
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia