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NCT01754493 · ClinicalTrials.gov registry record · Phase 4

Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression

A Phase 4 study, sponsored by New York State Psychiatric Institute.

Completed
Registry status
Phase 4
Development phase
17
Enrollment target

NCT01754493: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.

NCT01754493 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01754493, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 4
Development phase
17 participants
Enrollment target

Study Summary

This study will evaluate the efficacy of duloxetine in reducing depressive symptoms, abdominal pain, and other symptoms of Irritable Bowel Syndrome (IRS) in a population of outpatients with Major Depressive Disorder MDD and clinical symptoms of IBS.

Primary Outcome

Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression.

Interventions

  • DRUG Duloxetine

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2008-12
Est. Completion 2014-12
Phase Phase 4

What the finished NCT01754493 record still lists

NCT01754493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

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

NCT01754493 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01754493 about?

NCT01754493 is a clinical study titled "Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression". This study will evaluate the efficacy of duloxetine in reducing depressive symptoms, abdominal pain, and other symptoms of Irritable Bowel Syndrome (IRS) in a population of outpatients with Major Depressive Disorder MDD and clinical symptoms of IBS.

What is the current status of trial NCT01754493?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2008-12. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01754493?

The interventions under investigation include: Duloxetine (DRUG).

Who is sponsoring clinical trial NCT01754493?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01754493's enrollment target sits among peer trials

17 1854th of 2000 higher than 132 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 NCT01754493, the US trial registry maintained by the National Library of Medicine. NCT01754493 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.