A Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible-Dose Desvenlafaxine Treatment in Outpatients with Major Depressive Disorder

Feiger, Alan D.; Tourian, Karen A.; Rosas, Gregory; Padmanabhan, S. Krishna

doi:10.1017/s1092852900020046

Cited by 39 publications

(8 citation statements)

References 10 publications

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“…Outpatients who met diagnostic criteria for MDD and presented with HAM-D 17 total scores of greater than or equal to 20 at study entry were enrolled in the 10 placebo-controlled, short-term, desvenlafaxine clinical trials (conducted in the USA and at various international sites) that were included in these analyses (DeMartinis et al, 2007;Liebowitz et al, 2007;Septien-Velez et al, 2007;Boyer et al, 2008;Lieberman et al, 2008;Liebowitz et al, 2008;Feiger et al, 2009;Tourian et al, 2009;Kornstein et al, 2010). For all analyses, the individual desvenlafaxine dose groups (intent-to-treat population) were pooled.…”

Section: Patientsmentioning

confidence: 99%

Assessing the relationship between functional impairment/recovery and depression severity

Guico-Pabia

Fayyad

Soares

2012

International Clinical Psychopharmacology

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The objective of this study was to explore the relationship between assessments of functional impairment, emotional well-being, and depression symptoms. Data were pooled from 3530 outpatients with major depressive disorder enrolled in 10 desvenlafaxine clinical trials. The primary outcome measures included (a) the 17-item Hamilton Rating Scale for Depression (HAM-D17) as a measure of depressive symptom severity and (b) the Sheehan Disability Scale (SDS) and five-item World Health Organization Well-Being Index (WHO-5) as measures of functional impairment and well-being. A linear regression model was used to identify the SDS and WHO-5 values that equate to the predetermined clinically relevant three-point difference between active treatment and placebo on the HAM-D17. A receiver operating characteristic analysis was conducted to determine the SDS score that equates to a remission of depression symptoms (i.e. HAM-D17≤7). An approximate three-point difference between active treatment and placebo on the SDS (2.8) and WHO-5 (2.5) was determined to be clinically relevant in relation to improvements in depressive symptoms. An SDS of less than or equal to 7 was equivalent to a remission of depression symptoms, providing a definition of functional remission. A better understanding of the relationship between depressive symptoms and functional impairment and well-being may provide clinicians with a more comprehensive means of assessing treatment effects in major depressive disorder.

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Section: Patientsmentioning

confidence: 99%

Assessing the relationship between functional impairment/recovery and depression severity

Guico-Pabia

Fayyad

Soares

2012

International Clinical Psychopharmacology

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“…The experiment was performed in four randomized sessions on separate days: control session (1 placebo tablet given orally, 6 h before the study), DVS session (50 mg DVS given orally, 6 h before the study), propranolol session (1 mg·kg Ϫ1 ·h Ϫ1 iv, immediately before the study), and propranolol ϩ DVS session (50 mg DVS given orally, 6 h before the study and 1 mg·kg Ϫ1 ·h Ϫ1 iv propranolol, immediately before the study). The dose of 50 mg for DVS was based on a previous study (16). We chose to give DVS 6 h before the study (or about 7 h before the actual recordings) because the maximum plasma concentration of DVS was reported to be 7 to 8 h after oral administration (35).…”

Section: Experimental Protocolsmentioning

confidence: 99%

Inhibitory effects of desvenlafaxine on gastric slow waves, antral contractions, and gastric accommodation mediated via the sympathetic mechanism in dogs

Dai¹,

Lei²,

Chen

2011

American Journal of Physiology-Gastrointestinal and Liver Physi

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Desvenlafaxine succinate (DVS; Pristiq) is a new antidepressant, serotonin-norepinephrine reuptake inhibitor. Antidepressants have been widely used for the treatment of functional gastrointestinal disorders. Possible roles of DVS on gastrointestinal motility have not been studied. The aim of this study was to investigate the effects of DVS on gastric slow waves (GSW), antral contractions, and gastric accommodation in dogs. Fifteen healthy dogs implanted with gastric serosal electrodes and a gastric cannula were studied in four separate sessions: control, DVS (50 mg), propranolol (1 mg·kg Ϫ1 ·h Ϫ1 ), and propranolol ϩ DVS. GSW were measured via the gastric serosal electrodes. Antral contractions were assessed via an intraluminal manometric catheter inserted via the gastric cannula. The sympathovagal activity was assessed from the spectral analysis of the heart rate variability signal. Gastric tone was measured by barostat via an intragastric balloon inserted into the fundus via the gastric cannula. In the postprandial period, in comparison with the control, DVS reduced the percentage of normal GSW (P ϭ 0.001) and increased the percentage of tachygastria (P ϭ 0.005) and bradygastria (P ϭ 0.002). Simultaneously, DVS increased the sympathetic activity (P ϭ 0.006) and the sympathovagal ratio (low frequency/high frequency; P ϭ 0.044). These effects were blocked by propranolol. DVS attenuated postprandial antral contractions and gastric accommodation. The postprandial antral contractile index (area under the curve) was decreased by 26% with DVS (P ϭ 0.013), and gastric accommodation was decreased by about 50% with DVS (P Ͻ 0.001). The inhibitory effect of DVS on gastric accommodation was blocked by propranolol. DVS inhibits gastric contractions, slow waves, and accommodation in the fed state. These inhibitory effects are associated with an increased sympathetic modulation in the gastrointestinal system. Cautions should be made when DVS is used for treating patients with depression and gastric motility disorders. desvenlafaxine succinate; antidepressants; gastrointestinal motility ANTIDEPRESSANTS ARE WIDELY used for the treatment of functional gastrointestinal disorders, such as functional dyspepsia and irritable bowel syndrome (17,20,55). The rationale for the use of antidepressants in functional gastrointestinal disorders is based on the following potential effects. First, antidepressants may improve psychiatric and psychological symptoms, particularly anxiety and depression (11,18,47). Second, antidepressants have central analgesic actions and alter central processing of visceral pain stimuli (10, 27). Third, antidepressants may have local pharmacological actions on the gut and modulate gut sensorimotor functions (3,8,9).Desvenlafaxine succinate (DVS; Pristiq) is a new antidepressant, the third serotonin-norepinephrine reuptake inhibitor (SNRI) approved by the U.S. Food and Drug Administration for the treatment of major depressive disorders in 2008 (26, 35). It is a novel salt form of the isolated major active metab...

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“…[31][32][33][34][35][36] Several published abstracts were also reviewed: including a fl exible dose trial of DVS 200 to 400 mg, 37 a trial comparing DVS 50 and 100 mg to placebo with a duloxetine reference arm, 8 as well as two unpublished pooled analyses, the fi rst involving 7 short-term trials with DVS doses between 100 and 400 mg 39 and the second from 2 trials with DVS at 50 and 100 mg. 40 Other studies of DVS as a treatment for vasomotor symptoms of menopause and pain were not reviewed. No published trials for generalized anxiety disorder or other anxiety disorders were located.…”

Section: Effi Cacy In Clinical Trialsmentioning

confidence: 99%

Desvenlafaxine in the treatment of major depressive disorder

Lourenço

Kennedy²

2009

NDT

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Major depressive disorder (MDD) is among the most incapacitating conditions in the world. The emergence of the selective serotonin reuptake inhibitor (SSRI) and serotonin norepinephrine reuptake inhibitors (SNRI) antidepressants has improved the treatment of MDD. Desvenlafaxine succinate (DVS) is the succinate salt of the isolated major active metabolite of venlafaxine, O-desmethylvenlafaxine: it is the third SNRI to become available in the United States, and was approved in 2008 by the US Food and Drug Administration (FDA) for the treatment of MDD. Early investigations showed therapeutic effi cacy for doses between 50 and 400 mg/day; however in doses above 100 mg/day there were incremental increases in side effects. Nausea was the most frequent adverse effect. Hence the recommended dosing for DVS is in the 50 to 100 mg range. Desvenlafaxine is excreted in urine, it is minimally metabolized via the CYP450 pathway, and is a weak inhibitor of CYP2D6. A reduced risk for pharmacokinetic drug interactions is a potential advantage over other SNRI. Further head-to-head trials involving comparisons of DVS in the 50 to 100 mg dose range with currently available SSRI and SNRI antidepressants are required. Evidence for relapse prevention is available in the 200 to 400 mg dose range, but this needs to be demonstrated in the 50 to 100 mg dose range, as well as health economic measures and quality of life evaluations.

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A Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible-Dose Desvenlafaxine Treatment in Outpatients with Major Depressive Disorder

Cited by 39 publications

References 10 publications

Assessing the relationship between functional impairment/recovery and depression severity

Assessing the relationship between functional impairment/recovery and depression severity

Inhibitory effects of desvenlafaxine on gastric slow waves, antral contractions, and gastric accommodation mediated via the sympathetic mechanism in dogs

Desvenlafaxine in the treatment of major depressive disorder

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