Duloxetine for Chronic Depression: a Double-blind Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00360724
First received: August 3, 2006
Last updated: October 2, 2012
Last verified: October 2012

August 3, 2006
October 2, 2012
August 2006
December 2011   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale [ Time Frame: 10 weeks, 22 weeks ] [ Designated as safety issue: Yes ]
  • Hamilton Depression Rating Scale
  • Clinical Global Impressions
Complete list of historical versions of study NCT00360724 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Cornell Dysthymia Rating Scale
  • Global Assessment of Functioning Scale
  • Beck Depression Inventory
  • Magnetic Resonance Imaging, Anatomical
  • Magnetic Resonance Imaging, Functional
  • Magnetic Resonance Spectroscopy
Not Provided
Not Provided
 
Duloxetine for Chronic Depression: a Double-blind Study
Duloxetine for Chronic Depression: a Double-blind Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dysthymic Disorder
  • Depressive Disorder NOS
Drug: Duloxetine (Cymbalta)
duloxetine medication up to dose of 120 mg/day
Other Names:
  • duloxetine
  • Cymbalta
  • Experimental: duloxetine (cymbalta)
    Duloxetine medication
    Intervention: Drug: Duloxetine (Cymbalta)
  • Placebo Comparator: 2
    placebo treatment
    Intervention: Drug: Duloxetine (Cymbalta)
Hellerstein DJ, Stewart JW, McGrath PJ, Deliyannides DA, Batchelder ST, Black SR, Withers A, O'Shea D, Chen Y. A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression. J Clin Psychiatry. 2012 Jul;73(7):984-91. doi: 10.4088/JCP.11m07230.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2013
December 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00360724
NYSPI IRB# 4967
No
New York State Psychiatric Institute
New York State Psychiatric Institute
Eli Lilly and Company
Principal Investigator: David J. Hellerstein, MD New York State Psychiatric Institute
New York State Psychiatric Institute
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP