Duloxetine for Chronic Depression: a Double-blind Study

Completed · Phase 4 · Has a placebo group

Conditions studied: Dysthymic Disorder, Depressive Disorder NOS

In brief

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.

Key facts

Study ID

NCT00360724

Run by

New York State Psychiatric Institute

People needed

65

Starts

2006-08-01

Expected to finish

2013-12-01

Last updated by the study team

2017-08-21

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age 20 to 75 years (ages 20 to 60 for MRI sub-study)
• diagnosis of dysthymic disorder (chronic depression) or depression NOS
• minimum of 2 years duration of current episode of depression

You may not qualify if…

• current major depression
• diagnoses including delirium, dementia, bipolar disorder, schizophrenia
• substance abuse or dependence in the past 6 months
• pregnant or nursing women
• serious risk of suicide

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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