Duloxetine for Chronic Depression: a Double-blind Study
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.
Timeline
- Start
- 2006-08
- Primary completion
- 2011-12
- Completion
- 2013-12
Outcome
Met primary endpoint
paper After 10 weeks, duloxetine-treated subjects had significantly lower 24-item HDRS scores than placebo-treated subjects PMID 22901348 ↗
registry Duloxetine (Cymbalta) vs Placebo Treatment; p = .003 NCT00360724 ↗
Publications
- Results 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.
- Bansal R, Hellerstein DJ, Sawardekar S, Chen Y, Peterson BS. Effects of antidepressant medications on brain tissue microstructure in persistent depressive disorder across two randomized controlled trials. Neuroimage Clin. 2026;50:104013. doi: 10.1016/j.nicl.2026.104013. Epub 2026 May 27.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 120 mg | — |