Duloxetine in the Treatment of Major Depressive Disorder: A Double-Blind Clinical Trial
Abstract
BACKGROUND: Duloxetine hydrochloride, a dual reuptake inhibitor of serotonin and norepinephrine, was evaluated for therapeutic efficacy and safety/tolerability in the treatment of major depression. METHOD: In an 8-week multicenter, double-blind, placebo-controlled study, 173 patients (aged 18-65 years) with DSM-IV major depressive disorder were randomly allocated to receive placebo (N = 70), duloxetine (N = 70), or fluoxetine, 20 mg q.d. (N = 33). Duloxetine dose was titrated in the first 3 weeks in a forced-titration regimen from 40 mg (20 mg b.i.d.) to 120 mg/day (60 mg b.i.d.). Patients were required to have a Clinical Global Impressions (CGI)-Severity of Illness scale score of at least moderate severity (> or = 4) and a 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of at least 15. Patients could not have had any current primary DSM-IV Axis I diagnosis other than major depressive disorder, or any anxiety disorder as a primary diagnosis within the past year, excluding specific phobias. The primary efficacy measurement was the HAM-D-17 total score, and secondary measures included the Montgomery-Asberg Depression Rating Scale, CGI-Severity of Illness and CGI-Improvement, and Patient Global Impression of Improvement. Safety was evaluated by recording the occurrence of discontinuation rates and treatment-emergent adverse events and by measurement of vital signs and laboratory analytes. RESULTS: Duloxetine was superior to placebo in change on the HAM-D-17 (p = .009). Estimated probabilities of response and remission were 64% and 56%, respectively, for duloxetine, compared with 52% and 30% for fluoxetine and 48% and 32% for placebo. Duloxetine was numerically superior to fluoxetine on the primary and most of the secondary outcome measures. In general, duloxetine was well tolerated; 76% of patients achieved the maximum dose, and insomnia and asthenia were the only adverse events reported statistically significantly (p < .05) more frequently by duloxetine-treated patients compared with placebo-treated patients. CONCLUSION: These data indicate that duloxetine is efficacious for the treatment of major depressive disorder and is well tolerated and safe.
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Duloxetine is a well-tolerated, efficacious SNRI antidepressant.
“Duloxetine is a well-tolerated, efficacious [28–30] SNRI antidepressant”
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PRACTICE GUIDELINE FOR THE Treatment of Patients With Major Depressive Disorder
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- Authors
- Goldstein, D. J., Mallinckrodt, C., Lu, Y., & Demitrack, M. A.
- Affiliations
- Eli Lilly (United States) (US)
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2002-03-15
- Volume
- 63
- Issue
- 3
- Pages
- 225-231
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W2003363634
- Cited by
- 334
- References
- 0
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 4 · 2023: 1 · 2022: 3 · 2021: 2 · 2020: 9 · 2019: 9 · 2018: 7 · 2017: 6 · 2016: 13 · 2015: 12 · 2014: 11 · 2013: 14 · 2012: 10
- FWCI
- 17.36
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Clinical Psychology › Psychological Treatments and Disorders
- Keywords
- duloxetine, major depressive disorder, serotonin-norepinephrine reuptake inhibitors, fluoxetine, antidepressant efficacy, drug safety and tolerability, treatment response and remission, insomnia, asthenia, adverse events
- MeSH terms
- Duloxetine Hydrochloride, Adult, Antidepressive Agents, Blood Pressure, Body Weight, Major Depressive Disorder, Double-Blind Method, Drug Administration Schedule, Female, Fluoxetine, Humans, Male, Middle Aged, Thiophenes, Treatment Outcome, Outcome Assessment, Health Care, Selective Serotonin Reuptake Inhibitors, Adrenergic Uptake Inhibitors, Dopamine Uptake Inhibitors
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