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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 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 370 participants.

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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.

Interventions

  • DRUG placebo
  • DRUG duloxetine hydrochloride

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2006-11
Est. Completion 2009-11
Phase Phase 4

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT00406848

The ClinicalTrials.gov registry entry for NCT00406848 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 370 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.

NCT00406848 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.