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NCT01118780 · ClinicalTrials.gov registry record · Phase 4

A Study of Duloxetine in Elderly Generalized Anxiety Disorder

A Phase 4 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 4
Development phase
291
Enrollment target

NCT01118780: Completed Phase 4 study, sponsored by Eli Lilly and Company.

NCT01118780 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 291 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01118780, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 4
Development phase
291 participants
Enrollment target

Study Summary

The purpose of this study is to test the safety and efficacy of duloxetine versus placebo in elderly patients suffering from generalized anxiety disorder (GAD).

Primary Outcome

The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled

Interventions

  • DRUG Placebo
  • DRUG Duloxetine

Trial Details

FieldValue
Enrollment Target 291 participants
Start Date 2010-10
Est. Completion 2012-07
Phase Phase 4
Eli Lilly and Company

1,341 total trials

What the finished NCT01118780 record still lists

NCT01118780 is an interventional study that assigns participants to a tested intervention. The registered 291 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 (44% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01118780 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01118780 about?

NCT01118780 is a clinical study titled "A Study of Duloxetine in Elderly Generalized Anxiety Disorder". The purpose of this study is to test the safety and efficacy of duloxetine versus placebo in elderly patients suffering from generalized anxiety disorder (GAD).

What is the current status of trial NCT01118780?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 291 participants. The study started on 2010-10. Estimated completion is 2012-07.

What interventions are being tested in trial NCT01118780?

The interventions under investigation include: Placebo (DRUG), Duloxetine (DRUG).

Who is sponsoring clinical trial NCT01118780?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01118780's enrollment target sits among peer trials

291 297th of 2000 higher than 1,704 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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Source: ClinicalTrials.gov NCT01118780, the US trial registry maintained by the National Library of Medicine. NCT01118780 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.