Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 776 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00536471
The ClinicalTrials.gov registry entry for NCT00536471 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 776 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00536471 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.