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NCT01035073 · ClinicalTrials.gov registry record · Phase 4

Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome

A Phase 4 study, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 4
Development phase
22
Enrollment target

NCT01035073: Completed Phase 4 study, sponsored by University of Pennsylvania.

NCT01035073 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01035073, a Phase 4 study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 4
Development phase
22 participants
Enrollment target

Study Summary

The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures. We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed.

Interventions

  • DRUG Duloxetine

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2006-04
Est. Completion 2009-05
Phase Phase 4
University of Pennsylvania

1,423 total trials

What the finished NCT01035073 record still lists

NCT01035073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Duloxetine is the first listed.

NCT01035073 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01035073 about?

NCT01035073 is a clinical study titled "Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome". The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures. We hypothesize that there will be a reduction in both MDD and STD...

What is the current status of trial NCT01035073?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2006-04. Estimated completion is 2009-05.

What interventions are being tested in trial NCT01035073?

The interventions under investigation include: Duloxetine (DRUG).

Who is sponsoring clinical trial NCT01035073?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01035073's enrollment target sits among peer trials

22 1731st of 2000 higher than 259 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 NCT01035073, the US trial registry maintained by the National Library of Medicine. NCT01035073 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.