Clinical trial NCT00360724: Duloxetine for Chronic Depression: a Double-blind Study
Official title: Duloxetine for Chronic Depression: a Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysthymic Disorder
Depressive Disorder NOS
Keywords: 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
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2006-08-07
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS) - 24 Total Score
timeFrame: Week 10
measure: Hamilton Depression Rating Scale (HDRS) - 24 Total Score
timeFrame: Baseline
Secondary outcomes:
measure: Cornell Dysthymia Rating Scale (CDRS)
timeFrame: Week 10
measure: Global Assessment of Functioning Scale (GAF)
timeFrame: Week 10
measure: Beck Depression Inventory (BDI)
timeFrame: Week 10
measure: Clinical Global Impressions Improvement(CGI-I)
timeFrame: 10 weeks
measure: Cornell Dysthymia Rating Scale (CDRS)
timeFrame: Baseline
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline
measure: Global Assessment of Functioning Scale (GAF)
timeFrame: Baseline
Other outcomes:
measure: Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)
timeFrame: Baseline
measure: Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)
timeFrame: Follow up
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: David J. Hellerstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Yang J, Hellerstein DJ, Chen Y, McGrath PJ, Stewart JW, Peterson BS, Wang Z. Serotonin-norepinephrine reuptake inhibitor antidepressant effects on regional connectivity of the thalamus in persistent depressive disorder: evidence from two randomized, double-blind, placebo-controlled clinical trials. Brain Commun. 2022 Apr 15;4(3):fcac100. doi: 10.1093/braincomms/fcac100. eCollection 2022.
citation: Bansal R, Hellerstein DJ, Sawardekar S, O'Neill J, Peterson BS. Effects of the antidepressant medication duloxetine on brain metabolites in persistent depressive disorder: A randomized, controlled trial. PLoS One. 2019 Jul 19;14(7):e0219679. doi: 10.1371/journal.pone.0219679. eCollection 2019.
citation: Hellerstein DJ, Hunnicutt-Ferguson K, Stewart JW, McGrath PJ, Keller S, Peterson BS, Chen Y. Do social functioning and symptoms improve with continuation antidepressant treatment of persistent depressive disorder? An observational study. J Affect Disord. 2017 Mar 1;210:258-264. doi: 10.1016/j.jad.2016.12.026. Epub 2016 Dec 20.