Purpose

We 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. We are testing whether this medicine is also effective for adults with chronic depression (also known as dysthymic disorder or dysthymia). Chronic depression, lasting two or more years, often causes significant suffering and impairment. Our 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 us understand how antidepressants work in treating depression.

Type of Study: Clinical Trial
Setting of Study: outpatient
Clinical Trials.gov number: NCT00360724
Providing Clinical Treatment?: Yes
No Cost Treatment?: Yes
Care is provided in languages: English

Study Activities

Filling Out Forms
Blood Samples
MRI Scan
Provides Payment: Reimbursement for transportation
Provides Payment: Compensation for study related procedures

Eligibility

Ages Eligible for Study: 20 Years - 75 Years
Genders Eligible for Study: Both
This study is not recruiting Healthy Volunteers.

Criteria

Inclusion Criteria:
1) age 23 to 75 years (ages 23 to 50 for MRI sub-study)
2) diagnosis of dysthymic disorder (chronic depression) or depression NOS
3)minimum of 2 years duration of current episode of depression


Links
Official website for Mood Disorders Research Program.
Depression Evaluation Service official site

Location: New York State Psychiatric Institute 1051 Riverside Dr. (at 168th St.) New York, NY 10032 Midtown location: 1775 Broadway, Suite # 1403 (at 57th St.) New York, NY 10019
Clinic: Depression Evaluation Service
Division: Therapeutics

Study chairs or principal investigators:
David J Hellerstein MD, Principal Investigator

Co-investigators:
Sarai Batchelder, PhD,
Patrick MdGrath, MD,
Jonathan Stewart, MD,
Deborah Deliayannides, MD,
Bradley Peterson, MD