Overview

This trial is active, not recruiting.

Conditions dysthymic disorder, depressive disorder nos
Treatment duloxetine (cymbalta)
Phase phase 4
Sponsor New York State Psychiatric Institute
Collaborator Eli Lilly and Company
Start date August 2006
End date December 2011
Trial size 60 participants
Trial identifier NCT00360724, NYSPI IRB# 4967

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Duloxetine medication
duloxetine (cymbalta) duloxetine
duloxetine medication up to dose of 120 mg/day
(Placebo Comparator)
placebo treatment
duloxetine (cymbalta) duloxetine
duloxetine medication up to dose of 120 mg/day

Primary Outcomes

Measure
Hamilton Depression Rating Scale
time frame: 10 weeks, 22 weeks

Secondary Outcomes

Measure
Cornell Dysthymia Rating Scale
time frame: 10 weeks, 22 weeks
Global Assessment of Functioning Scale
time frame: 10 weeks, 22 weeks
Beck Depression Inventory
time frame: 10 weeks, 22 weeks
Magnetic Resonance Imaging, Anatomical
time frame: 10 weeks, 22 weeks
Magnetic Resonance Imaging, Functional
time frame: 10 weeks, 22 weeks
Magnetic Resonance Spectroscopy
time frame: 10 weeks, 22 weeks
Clinical Global Impressions Improvement(CGI-I)
time frame: 10 weeks, 22 weeks

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

Official title Duloxetine for Chronic Depression: a Double-blind Study
Principal investigator David J. Hellerstein, MD
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, type 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, 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by New York State Psychiatric Institute.