CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 65 enrolled
Drug / intervention
Duloxetine (Cymbalta)drug
Likely dose
Duloxetine (Cymbalta) 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00360724
NCT00360724Phase 4Completed

Duloxetine for Chronic Depression: a Double-blind Study

New York State Psychiatric Institute·interventional·Posted Aug 7, 2006·Updated Aug 21, 2017

In Brief

A Phase 4 clinical trial evaluating Duloxetine (Cymbalta) for Dysthymic Disorder and Depressive Disorder NOS. Completed, enrolled 65 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2006
Enrollment StartAug 1, 2006
Primary CompletionDec 1, 2011
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 19.9 years ago

Interventions

Duloxetine (Cymbalta)drug

duloxetine medication up to dose of 120 mg/day