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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
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.40414243”
From Addressing the Side Effects of Contemporary Antidepressant Drugs: A Comprehensive Review (2018) · cites this paper as [41]
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“sis of eight comparative, randomised, double-blind cant difference was shown between venlafaxine and the studied TCAs or the studied novel antidepresstudies.[62-68] These trials involved 2045 patients and sant; however, the small number of studies measurefficacy was measured in terms of achieving remising remission ma…”
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“Nowadays, research claims that new antidepressants, such as mirtazapine or venlafaxine, generate a faster response (Kasper, 1995; Guelfi et al., 1995; Montgomery, 1997; Rudolph and Feiger, 1999).”
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“…physiological traits to an averaged healthy population, the accepted approach of measuring efficacy of pharmacological treatments in animal models of psychiatric disorders refers to averaged group results (Katz and Hersh, 1981; Bodnoff et al., 1989; Rudolph and Feiger, 1999; Dulawa et al., 2004).”
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“Finally, in their study of 301 out-patients (approximately 15% of subjects in meta-analysis), Rudolph & Feiger (1999) reported an almost 50% greater drop-out rate in the fluoxetine group compared with the venlafaxine group (29% v. 19%).”
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“This was followed by two more in 1998 and 1999 that matched up against Prozac, the latter of which specifically studied Effexor XR (Costa e Silva, 1998; Rudolph & Feiger, 1999).”
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Metadata
- 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)
- 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
- Locations
- Journal of Affective Disorders (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
- 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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