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NCT00406848 · ClinicalTrials.gov registry record · Phase 4
A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 370
- Enrollment target
NCT00406848: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT00406848 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 370 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00406848, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 370 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day.
Primary Outcome
The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).
Interventions
- DRUG placebo
- DRUG duloxetine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-11 |
| Phase | Phase 4 |
What the finished NCT00406848 record still lists
NCT00406848 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00406848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00406848 about?
NCT00406848 is a clinical study titled "A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients". The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients r...
What is the current status of trial NCT00406848?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 370 participants. The study started on 2006-11. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00406848?
The interventions under investigation include: placebo (DRUG), duloxetine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00406848?
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 NCT00406848's enrollment target sits among peer trials
370 223rd of 2000 higher than 1,777 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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