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NCT00536471 · ClinicalTrials.gov registry record · Phase 4
A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 776
- Enrollment target
NCT00536471: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT00536471 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 776 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00536471, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 776 participants
- Enrollment target
Study Summary
Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized, placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on depression in patients aged 18-65. Data from the two trials will be reported in both individual and pooled analyses. Pooling the two studies will allow for increased power to detect differences between duloxetine and placebo on secondary and exploratory objectives. Only one data lock is planned for this study, when all patients have completed all study procedures.
Primary Outcome
Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).
Interventions
- DRUG Placebo
- DRUG Duloxetine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 776 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
What the finished NCT00536471 record still lists
NCT00536471 is an interventional study that assigns participants to a tested intervention. The registered 776 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00536471 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00536471 about?
NCT00536471 is a clinical study titled "A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients". Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized, placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on depression in patients aged 18-65. Data fr...
What is the current status of trial NCT00536471?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 776 participants. The study started on 2007-09. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00536471?
The interventions under investigation include: Placebo (DRUG), Duloxetine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00536471?
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 NCT00536471's enrollment target sits among peer trials
776 105th of 2000 higher than 1,896 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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