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

The DOI matches its Crossref record.

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
Open this paper in CoChat — free account

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.

Overview

Integrity signals

Registry

Crossref · 10.4088/jcp.v63n0309

Cites

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Citations

Cited by

Sorted by citations

Items 301–335 of 335

Related

See all

Metadata

Authors
Goldstein, D. J., Mallinckrodt, C., Lu, Y., & Demitrack, M. A.
Affiliations
Eli Lilly (United States) (US)
ORCID
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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review