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

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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

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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“ITT Alves (1999) (45) 0Æ500 0Æ079 40 0Æ404 0Æ072 47 1Æ47 0Æ63 3Æ45 Ballus (2000) (29) 0Æ561 0Æ078 41 0Æ326 0Æ071 43 2Æ65 1Æ09 6Æ43 Bielsky (2004) (46) 0Æ420 0Æ049 100 0Æ505 0Æ051 97 0Æ71 0Æ40 1Æ24 Costa e Silva (1998) (47) 0Æ602 0Æ035 196 0Æ602 0Æ036 186 1Æ00 0Æ66 1Æ51 Detke (2004) (48) 0Æ505 0Æ052 93 0Æ471 0Æ054 85 1…”
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“Similar rates of Rudolph and Feiger 1999; Thase et al. 2001).”
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“Three studies comparing venlafaxine IR or XR with an active comparator were rejected after the active comparator was found to be no more effective than placebo (Schweizer et al., 1994; Lecrubier et al., 1997; Rudolph and Feiger, 1999).”
Influential
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“Factors tested for their potential predictive value were: (1) sex; (2) age at study start; (3) duration of current episode; (4) prior benzodiazepine use for the treatment of anxiety symptoms; (5) prior nonbenzodiazepine treatment of anxiety; (6) history of depression; (7) history of substance abuse; (8) history of pan…”
Background
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Self-citation
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“Previous studies have shown that α1 subunit was associated with sedation (Rudolph and Feiger, 1999; McKernan et al., 2000).”
Result
The Psychopharmacology Algorithm Project at the Harvard South Shore Program: An Update on Unipolar Nonpsychotic Depression
Giakoumatos, C. I., & Osser, D. N. (2019) · Harvard Review of Psychiatry · doi:10.1097/hrp.0000000000000197 · Cited by 27
An Open-Label Pilot Study of Combined Augmentation With Creatine Monohydrate and 5-Hydroxytryptophan for Selective Serotonin Reuptake Inhibitor– or Serotonin-Norepinephrine Reuptake Inhibitor–Resistant Depression in Adult Women
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Pharmaceutical Use Following Generic Entry: Paying Less and Buying Less
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Meta-analysis: Risk of hyperhidrosis with second-generation antidepressants
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Global benefit-risk assessment of antidepressants: venlafaxine XR and fluoxetine
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An indirect comparison of the efficacy and safety of desvenlafaxine and venlafaxine using placebo as the common comparator
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“3 55 (71) 23 (29) Unclear Unclear Unclear Unclear”
Background
Sexual Functioning in Patients With Recurrent Major Depressive Disorder Enrolled in the PREVENT Study
Gelenberg, A. J., Dünner, D. L., Rothschild, A. J., Pedersen, R., Dorries, K. M., & Ninan, P. T. (2013) · The Journal of Nervous and Mental Disease · doi:10.1097/nmd.0b013e318288d298 · Cited by 24
“, 2001), an active comparator in several venlafaxine ERMDD trials (Keller et al., 2007a; Nemeroff and Thase, 2007; Rudolph and Feiger, 1999; Shelton et al., 2005).”
BackgroundResult
Effect of milnacipran on extracellular monoamine concentrations in the medial prefrontal cortex of rats pre-treated with lithium
Kitaichi, Y., Inoue, T., Nakagawa, S., Izumi, T., & Koyama, T. (2005) · European Journal of Pharmacology · doi:10.1016/j.ejphar.2005.04.038 · Cited by 23
Efficacy of venlafaxine extended release in major depressive disorder patients
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The risks of adverse events with venlafaxine for adults with major depressive disorder: a systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis
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“…Learned et al. , 2012; Lieberman et al. , 2008; Luthringer et al. , 1996; Mendels et al. , 1993; Nemeroff et al. , 2007; Rudolph et al. , 1998; Rudolph and Feiger, 1999; Schatzberg and Roose, 2006; Schweizer et al. , 1994, 1991; Sharma et al. , 2016; Sheehan et al. , 2009; Silverstone and…”
Influential
A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan
Higuchi, T., Kamijima, K., Nakagome, K., Itamura, R., Asami, Y., Kuribayashi, K., & Imaeda, T. (2015) · International Clinical Psychopharmacology · doi:10.1097/yic.0000000000000105 · Cited by 22
“…new drug-related risks specific to a Japanese population and the most common AEs observed were consistent with the known profile of venlafaxine (Mendels et al., 1993; Cunningham, 1997; Thase 1997; Khan et al., 1998; Rudolph et al., 1998; Rudolph and Feiger, 1999; Silverstone and Ravindran, 1999).”
BackgroundResultInfluential
Somatic treatment for depressive illnesses in children and adolescents.
Findling, R., Feeny, N., Stansbrey, R. J., Delporto-Bedoya, D., & Demeter, C. A. (2002) · Child and Adolescent Psychiatric Clinics of North America · doi:10.1016/s1056-4993(02)00010-x · Cited by 11

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 (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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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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