Duloxetine for Chronic Depression: a Double-blind Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dysthymic Disorder Depressive Disorder NOS |
Drug: Duloxetine (Cymbalta) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Duloxetine for Chronic Depression: a Double-blind Study |
- Hamilton Depression Rating Scale [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: Yes ]
- Cornell Dysthymia Rating Scale [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
- Global Assessment of Functioning Scale [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
- Beck Depression Inventory [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
- Magnetic Resonance Imaging, Anatomical [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
- Magnetic Resonance Imaging, Functional [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
- Magnetic Resonance Spectroscopy [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impressions Improvement(CGI-I) [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: duloxetine (cymbalta)
Duloxetine medication
|
Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Other Names:
|
|
Placebo Comparator: 2
placebo treatment
|
Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Other Names:
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | David J. Hellerstein, MD | New York State Psychiatric Institute |
More Information
Additional Information:
No publications provided by New York State Psychiatric Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00360724 History of Changes |
| Other Study ID Numbers: | NYSPI IRB# 4967 |
| Study First Received: | August 3, 2006 |
| Last Updated: | October 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York State Psychiatric Institute:
|
dysthymia dysthymic disorder chronic depression chronic low-grade depression atypical depression minor depression |
depression NOS depression depressive disorder mood disorder unipolar depression low-grade depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Dysthymic Disorder Behavioral Symptoms Mood Disorders Mental Disorders Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013