Cited by 335Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesPsychological Treatments and Disorders

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Duloxetine in the Treatment of Major Depressive Disorder: A Double-Blind Clinical Trial

Goldstein, David J., Mallinckrodt, Craig, Lu, Yili, Demitrack, Mark A.·2002·The Journal of Clinical Psychiatry

DOI 10.4088/jcp.v63n0309

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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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Duloxetina y trastorno de ansiedad generalizada, una buena asociación
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Method
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Influential
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“32 However, that meta-analysis used studies performed in Europe and North America with duloxetine doses ranging from 40 to 120 mg/day 14,17,18,33–36 and with little consideration to dose titration, whereas starting with a subtherapeutic dose (ie, 30 mg/day) followed by escalation to therapeutic…”

Authors: Goldstein, D. J., Mallinckrodt, C., Lu, Y., & Demitrack, M. A.
Affiliations: Eli Lilly (United States) (US)
ORCID: Goldstein, David J.
Mallinckrodt, Craig
Demitrack, Mark A.
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)
DOI: 10.4088/jcp.v63n0309
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 (medical) › 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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Duloxetine in the Treatment of Major Depressive Disorder: A Double-Blind Clinical Trial

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