A double-blind, randomized, placebo-controlled trial of once-daily venlafaxine extended release (XR) and fluoxetine for the treatment of depression

Rudolph, Richard L; Feiger, Alan D

doi:10.1016/s0165-0327(99)00067-1

Cited by 158Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesPsychological Treatments and Disorders

A double-blind, randomized, placebo-controlled trial of once-daily venlafaxine extended release (XR) and fluoxetine for the treatment of depression

Rudolph, Richard L, Feiger, Alan D·1999·Journal of Affective Disorders

DOI 10.1016/s0165-0327(99)00067-1

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Abstract

Background We compared the efficacy and tolerability of venlafaxine XR with that of fluoxetine in a multicenter, randomized, double-blind, placebo-controlled study in depressed outpatients.Methods Outpatients, 18 years and older, who met DSM-IV criteria for major depressive disorder were included (n = 301 randomized; 232 completed). Patients were randomly assigned to eight weeks of treatment with either venlafaxine XR 75-225 mg/day (n = 100), fluoxetine 20-60 mg/day (n = 103), or placebo (n = 98). The primary efficacy outcome measures were the final ratings on the Hamilton Rating Scale for Depression (HAM-D21) total score, HAM-D21 depressed mood item, Montgomery-Asberg Depression Rating Scale total score, and Clinical Global Impressions Scale.Results Withdrawal from the study due to adverse events occurred in 6% of the patients in the venlafaxine XR group and 9% of the patients in the fluoxetine group. Patients treated with venlafaxine XR, but only rarely those treated with fluoxetine, had statistically significant improvements in their depression ratings compared with placebo at the end of the study. The percentages of patients who achieved full remission of their depression (HAM-D21 total score < or = 7) at the end of treatment were 37%, 22% and 18% for the venlafaxine XR, fluoxetine and placebo groups, respectively. The differences in remission rates between venlafaxine XR and the other groups were statistically significant (p < 0.05).Limitations The superior remission outcome observed with venlafaxine XR treatment needs to be replicated in additional studies.Conclusion Venlafaxine XR is a well-tolerated and efficacious treatment for depression. The results of this study suggest that venlafaxine XR is as well-tolerated as fluoxetine but may have some efficacy advantages over fluoxetine.

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Among second generation antidepressants, venlafaxine consistently showed a higher rate of nausea and vomiting than SSRIs.
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“3 55 (71) 23 (29) Unclear Unclear Unclear Unclear”
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Authors: Rudolph, R. L., & Feiger, A. D.
Affiliations: Wyeth (US)
Corresponding author: Rudolph, Richard L
Venue: Journal of Affective Disorders
Publisher: Elsevier BV
Published: 1999-12
Volume: 56
Issue: 2-3
Pages: 171-181
ISSN: 0165-0327 (ISSN-L)
DOI: 10.1016/s0165-0327(99)00067-1
OpenAlex: W1975870015
Cited by: 158
References: 15
Citations by year: 2024: 3 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 2 · 2019: 4 · 2018: 3 · 2017: 3 · 2016: 3 · 2015: 6 · 2014: 4 · 2013: 3 · 2012: 2
FWCI: 6.52
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Affective Disorders (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: venlafaxine extended release, fluoxetine, major depressive disorder, depression treatment, antidepressant efficacy, antidepressant tolerability, depression remission, outpatients, adverse events
MeSH terms: Venlafaxine Hydrochloride, Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Cyclohexanols, Delayed-Action Preparations, Depressive Disorder, Double-Blind Method, Female, Fluoxetine, Humans, Male, Middle Aged, Treatment Outcome, Antidepressive Agents, Second-Generation

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A double-blind, randomized, placebo-controlled trial of once-daily venlafaxine extended release (XR) and fluoxetine for the treatment of depression

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