Duloxetine for Chronic Depression: a Double-blind Study

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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