Duloxetine for Chronic Depression: a Double-blind Study
| Status: | Completed |
|---|---|
| Conditions: | Depression, Endocrine |
| Therapuetic Areas: | Endocrinology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 20 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | August 2006 |
| End Date: | December 2013 |
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.
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.
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.
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.
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
We found this trial at
1
site
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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