Duloxetine for Chronic Depression: a Double-blind Study

New York State Psychiatric Institute

Status and phase: Completed; Phase 4

Conditions: Dysthymic Disorder; Depressive Disorder NOS

Treatments: Drug: Duloxetine (Cymbalta)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00360724

# 4967/6363R

Details and patient eligibility

About

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.

Full description

This is a 22-week study of the tolerability, dosing, and efficacy of duloxetine in chronically depressed outpatients. Participants can have Dysthymic Disorder (Dysthymia), or Depression, Not Otherwise Specified (Depression NOS).

The first 10 weeks (Acute Phase) are double blind, placebo-controlled, and the second 12 weeks (Continuation Phase) is open-label and all subjects will receive active medication.

Tests of cytokine functioning will be performed and analyzed for treatment and placebo effects.

In addition, a subset of patients will be enrolled into an Magnetic Resonance Imaging (MRI) sub-study, in which a variety of brain imaging techniques (including anatomical MRI, functional MRI (fMRI), MR Spectroscopy, and Diffusion Tensor Imaging) will be performed at baseline and week 10. Duloxetine responders will have a third MRI performed at week 22.

Enrollment: 65 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

duloxetine (cymbalta)

Experimental group

Description:

Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine

Treatment:

Drug: Duloxetine (Cymbalta)

Placebo treatment

Placebo Comparator group

Description:

placebo treatment: treatment with placebo capsules that match active medication capsules

Treatment:

Drug: Duloxetine (Cymbalta)