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NCT00360724 · ClinicalTrials.gov registry record · Phase 4

Duloxetine for Chronic Depression: a Double-blind Study

A Phase 4 study of Dysthymic Disorder and Depressive Disorder NOS, sponsored by New York State Psychiatric Institute.

Completed
Registry status
Phase 4
Development phase
65
Enrollment target
1
Study location

NCT00360724: Completed Phase 4 study of Dysthymic Disorder and Depressive Disorder NOS, sponsored by New York State Psychiatric Institute.

NCT00360724 is a Phase 4 study of Dysthymic Disorder and Depressive Disorder NOS that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 65 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00360724, a Phase 4 study of Dysthymic Disorder and Depressive Disorder NOS, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 4
Development phase
65 participants
Enrollment target
1
Study location

Study Summary

The investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with chronic depression (dysthymic disorder or dysthymia). Chronic depression, lasting two or more years, often causes significant suffering and impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin, during which all subjects can be treated with an FDA-approved antidepressant medication. Eligible subjects may also receive MRI scans, to help the investigators understand how antidepressants work in treating depression.

Primary Outcome

HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression

Interventions

  • DRUG Duloxetine (Cymbalta)

Study Locations (1)

New York

  • New York State Psychiatric Institute - New York

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2006-08
Est. Completion 2013-12
Phase Phase 4

What the finished NCT00360724 record still lists

NCT00360724 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).

The record links to 2 conditions, with Dysthymic Disorder appearing as the primary indexed condition, and to 1 intervention - of which Duloxetine (Cymbalta) is the first listed.

NCT00360724 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT00360724 about?

NCT00360724 is a clinical study titled "Duloxetine for Chronic Depression: a Double-blind Study". The investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effectiv...

What is the current status of trial NCT00360724?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2006-08. Estimated completion is 2013-12.

What conditions does trial NCT00360724 study?

This clinical trial studies the following conditions: Dysthymic Disorder, Depressive Disorder NOS.

What interventions are being tested in trial NCT00360724?

The interventions under investigation include: Duloxetine (Cymbalta) (DRUG).

Who is sponsoring clinical trial NCT00360724?

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

Where is trial NCT00360724 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Dysthymic Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00360724's enrollment target sits among peer trials

65 1091st of 2000 higher than 904 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 NCT00360724, the US trial registry maintained by the National Library of Medicine. NCT00360724 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.