A Double-Blind Comparison of Escitalopram and Venlafaxine Extended Release in the Treatment of Major Depressive Disorder

Bielski, Robert J.; Ventura, Daniel; Chang, Chung-Chi

doi:10.4088/jcp.v65n0906

Cited by 154 publications

(112 citation statements)

References 26 publications

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“…There has been a remarkable increase in the reporting of 'remission' as an outcome in acute phase efficacy trials of MDE (eg, Keller et al, 1998;Sackeim et al, 2000;Alpert et al, 2002Alpert et al, , 2004Rush et al, 2003a;Bielski et al, 2004;Fava et al, 2004;Goldstein et al, 2004;Montgomery et al, 2004;Nelson et al, 2004;Perlis et al, 2004;Prudic et al, 2004;Trivedi et al, 2004a) and in pooled or meta-analyses (Lepola et al, 1998;Beasley et al, 2000;Entsuah et al, 2001;Thase et al, 2001;Dawson et al, 2004). In fact, reports of differential medication effects have resulted from some post hoc analyses using pooled samples in short-term (8-week) acute phase medication trials.…”

Section: The Increasing Importance Of Remission Clinical Implicationsmentioning

confidence: 99%

Report by the ACNP Task Force on Response and Remission in Major Depressive Disorder

Rush¹,

Kraemer

Sackeïm

et al. 2006

Neuropsychopharmacol

608

489

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This report summarizes recommendations from the ACNP Task Force on the conceptualization of remission and its implications for defining recovery, relapse, recurrence, and response for clinical investigators and practicing clinicians. Given the strong implications of remission for better function and a better prognosis, remission is a valid, clinically relevant end point for both practitioners and investigators. Not all depressed patients, however, will reach remission. Response is a less desirable primary outcome in trials because it depends highly on the initial (often single) baseline measure of symptom severity. It is recommended that remission be ascribed after 3 consecutive weeks during which minimal symptom status (absence of both sadness and reduced interest/pleasure along with the presence of fewer than three of the remaining seven DSM-IV-TR diagnostic criterion symptoms) is maintained. Once achieved, remission can only be lost if followed by a relapse. Recovery is ascribed after at least 4 months following the onset of remission, during which a relapse has not occurred. Recovery, once achieved, can only be lost if followed by a recurrence. Day-to-day functioning and quality of life are important secondary end points, but they were not included in the proposed definitions of response, remission, recovery, relapse, or recurrence. These recommendations suggest that symptom ratings that measure all nine criterion symptom domains to define a major depressive episode are preferred as they provide a more certain ascertainment of remission. These recommendations were based largely on logic, the need for internal consistency, and clinical experience owing to the lack of empirical evidence to test these concepts. Research to evaluate these recommendations empirically is needed.

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Section: The Increasing Importance Of Remission Clinical Implicationsmentioning

confidence: 99%

Report by the ACNP Task Force on Response and Remission in Major Depressive Disorder

Rush¹,

Kraemer

Sackeïm

et al. 2006

Neuropsychopharmacol

608

489

View full text Add to dashboard Cite

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“…Adverse events were assessed with a locally developed Adverse Event Record form based on the literature [Bielski et al, 2004;Burke et al, 2002;Colonna et al, 2002;Lepola et al, 2003;Montgomery et al, 2004;Wade et al, 2002]. The severity of adverse events was rated by the investigator as mild (patient aware of a symptom, but easily tolerated), moderate (discomfort enough to interfere with usual activity), or severe (incapacitating, with inability to work or perform routine activities).…”

Section: Treatments and Assessmentsmentioning

confidence: 99%

“…Some studies indicate early symptom reduction with escitalopram [Azorin et al, 2004;Montgomery et al, 2001]. Escitalopram has been studied in randomized clinical trials versus placebo [Burke et al, 2002;Kasper et al, 2005;Lepola et al, 2003;Wade et al, 2002], citalopram [Burke et al, 2002;Colonna et al, 2002Colonna et al, , 2005Gorman et al, 2002], venlafaxine [including extended release; Bielski et al, 2004;Montgomery et al, 2004], and fluoxetine [Kasper et al, 2005]. In all but one trial [Kasper et al, 2005], escitalopram was superior to placebo and was at least as efficacious as the active comparator.…”

Section: Introductionmentioning

confidence: 99%

Escitalopram in major depressive disorder: a multicenter, randomized, double-blind, fixed-dose, parallel trial in a Chinese population

et al. 2008

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Escitalopram, the S‐enantiomer of citalopram and the most selective of the selective serotonin reuptake inhibitor (SSRI) has been shown to be efficacious in the treatment of major depression in white populations. Our aim in this study was to investigate the efficacy and tolerability of escitalopram in Chinese patients with moderate to severe major depression. Patients who met DSM‐IV criteria for a major depressive episode were enrolled in this multicenter, randomized, double‐blind, fixed‐dose comparison trial. Patients were given escitalopram 10 mg/day or fluoxetine 20 mg/day for 8 weeks. All patients were assessed with the 17‐item Hamilton Depression Rating Scale (HAM‐D‐17) and the Montgomery–Åsberg Depression Rating Scale (MADRS). Tolerability was assessed on the basis of adverse effects (measured with a locally developed checklist), regular biochemical tests, and electrocardiograph (ECG) assessments. Two hundred forty patients were enrolled and randomized to escitalopram (123 patients) or fluoxetine (117 patients). The HAM‐D‐17 total scores of both groups decreased significantly from baseline, but there was no significant difference at week 8 between the two groups (15.8 for escitalopram and 14.7 for fluoxetine; P >.05). There were no significant differences in response rates at all visits after treatment based on either HAM‐D‐17 or MADRS. A post hoc analysis indicated that escitalopram was superior to fluoxetine on two items of the HAM‐D‐17: “depressed mood” (P =.023) and “work and interest” (P =.024). The adverse events reported in the escitalopram and fluoxetine groups were comparable, and most were mild to moderate. Both drugs showed good compliance profiles. Escitalopram 10 mg/day is at least as efficacious as fluoxetine 20 mg/day and well tolerated in Chinese patients with major depression, with possible superiority in some core symptoms such as “depressed mood” and “work and interest.” Depression and Anxiety 0:1–9, 2006. © 2006 Wiley‐Liss, Inc.

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“…According to the U.S. Food and Drug Administration (FDA), all adverse events resulting in a substantial disruption of a person's ability to conduct normal life functions can be considered serious adverse events [6]. Onset or worsening of sexual dysfunction as an adverse event associated with antidepressant use can result in premature discontinuation of antidepressant treatment, relapse of depression, and worsened health outcomes and quality of life [7][8][9].…”

Section: Introductionmentioning

confidence: 99%

Sexual Dysfunction associated with Second-Generation Antidepressants in Patients with Major Depressive Disorder: Results from a Systematic Review with Network Meta-Analysis

et al. 2013

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BACKGROUND: Sexual dysfunction (SD) is prevalent in patients with major depressive disorder (MDD) and is also associated with second-generation antidepressants (SGAD) which are commonly used to treat the condition. Evidence indicates underreporting of SD in efficacy studies. SD associated with antidepressant treatment is a serious side effect that may lead to early termination of treatment and worsening of quality of life. OBJECTIVES: To systematically assess the harms of SD associated with SGAD in adult patients with MDD by drug type. METHODS: We retrieved English-language abstracts from PubMed, EMBASE, the Cochrane Library, PsycINFO, and International Pharmaceutical Abstracts from 1980 to October 2012 as well as from reference lists of pertinent review articles and grey literature searches. Two independent reviewers identified randomized controlled trials (RCTs) of at least six weeks' duration and observational studies with at least 1,000 participants. STUDY SELECTION: Reviewers abstracted data on study design, conduct, participants, interventions, outcomes and method of SD ascertainment, and rated risk of bias. A senior reviewer checked and confirmed extracted data and risk of bias ratings. ANALYSES: Random effects network meta-analysis using Bayesian methods for data from head-to-head trials and placebo-controlled comparisons; descriptive analyses calculating weighted mean rates from individual trials and observational studies. RESULTS/ SYNTHESIS: Data from sixty-three studies of low and moderate risk of bias (58 RCTs, five observational studies) with more than 26,000 patients treated with SGAD were included. Based on network meta-analyses of 66 pairwise comparisons from 37 RCTs, most comparisons showed a similar risk of sexual dysfunction among included SGAD. Credible intervals, however, were wide and included differences that would be considered clinically relevant. We observed three main patterns: Bupropion had a statistically significantly lower risk of sexual dysfunction than some other SGAD, and both escitalopram, and paroxetine showed a statistically significantly higher risk of sexual dysfunction than some other SGAD. We found reporting of harms related to sexual dysfunction inconsistent and insufficient in some trials. LIMITATIONS: Most trials were conducted in highly selected populations. Search was restricted to English-language only. CONCLUSION AND IMPLICATIONS: Because of the indirect nature of the comparisons, the often wide credible intervals, and the high variation in magnitude of 2 outcome, we rated the overall strength of evidence with respect to our findings low. The current degree of evidence does not allow a precise estimate of comparative risk of sexual dysfunction associated with a specific antidepressant. In the absence of such evidence, clinicians need to be aware of SD as a common adverse event and should discuss patients' preferences before initiating antidepressant therapy.

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A Double-Blind Comparison of Escitalopram and Venlafaxine Extended Release in the Treatment of Major Depressive Disorder

Cited by 154 publications

References 26 publications

Report by the ACNP Task Force on Response and Remission in Major Depressive Disorder

Report by the ACNP Task Force on Response and Remission in Major Depressive Disorder

Escitalopram in major depressive disorder: a multicenter, randomized, double-blind, fixed-dose, parallel trial in a Chinese population

Sexual Dysfunction associated with Second-Generation Antidepressants in Patients with Major Depressive Disorder: Results from a Systematic Review with Network Meta-Analysis

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