A 10-Month, Open-Label Evaluation of Desvenlafaxine in Outpatients With Major Depressive Disorder

Tourian, Karen A.; Pitrosky, Bruno; Padmanabhan, S. Krishna; Rosas, Gregory

doi:10.4088/pcc.10m00977

Cited by 5 publications

(6 citation statements)

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“…The most common TEAEs reported by children and adolescents in this study were similar to those listed in short-term and long-term desvenlafaxine trials in adult patients with MDD (Clayton et al 2009;Tourian et al 2011;Rosenthal et al 2013). Statistically significant mean weight loss has been reported during short-term desvenlafaxine treatment in adult patients (Clayton et al 2009), but was not observed at any time point in children or adolescents in these studies.…”

Section: Discussionsupporting

confidence: 74%

Safety and Tolerability of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder

Findling

Groark

Chiles

et al. 2014

Journal of Child and Adolescent Psychopharmacology

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Objective: The purpose of this study was to assess long-term safety and tolerability of desvenlafaxine (administered as desvenlafaxine succinate) in children and adolescents with major depressive disorder (MDD). Methods: An 8 week, multicenter, open-label, fixed-dose study of children (ages 7-11 years) and adolescents (ages 12-17 years) with MDD was followed by a 6 month, flexible-dose extension study. Patients were administered desvenlafaxine 10-100 mg/day (children) or 25-200 mg/day (adolescents) for a total of 8 months. Treatment-emergent adverse events (AEs), withdrawals because of AEs, laboratory tests, vital signs, and the Columbia Suicide-Severity Rating Scale (C-SSRS) were collected. Eight month safety results from the lead-in plus extension studies are reported for extension study participants, using lead-in study day -1 as baseline. Results: Forty patients were enrolled in both studies (20 children; 20 adolescents). Of those, four children and three adolescents withdrew because of AEs. Treatment-emergent AEs reported by three or more patients were upper abdominal pain (15%) and headache (15%) in children, and somnolence (30%), nausea (20%), upper abdominal pain (15%), and headache (15%) in adolescents. Negativism (oppositional behavior) in a child was the single serious AE reported. No deaths occurred during the lead-in or extension studies. Mean pulse rates demonstrated statistically significant increases from lead-in study baseline to final evaluation (children, + 5.2 bpm; adolescents, + 5.9 bpm; p £ 0.05). No statistically significant change in blood pressure was observed at final evaluation. Two adolescents (0 children) reported suicidal ideation on the C-SSRS at screening assessment and during the lead-in and/or extension trials; one adolescent reported suicidal ideation after screening only. Conclusions: Long-term (8 month) treatment with desvenlafaxine was generally safe and well tolerated in depressed children and adolescents.

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Section: Discussionsupporting

confidence: 74%

Safety and Tolerability of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder

Findling

Groark

Chiles

et al. 2014

Journal of Child and Adolescent Psychopharmacology

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“…Vortioxetine increases the extracellular levels of acetylcholine, norepinephrine, serotonin, histamine, and dopamine in the CNS (Rothschild et al , ). Desvenlafaxine, used in the management of major depressive disorder, was shown to cause xerostomia only during the first 2–3 weeks of therapy (Tourian et al , ).…”

Section: Resultsmentioning

confidence: 99%

World Workshop on Oral MedicineVI: a systematic review of medication‐induced salivary gland dysfunction

et al. 2016

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The aim of this paper was to perform a systematic review of the pathogenesis of medication-induced salivary gland dysfunction (MISGD). Review of the identified papers was based on the standards regarding the methodology for systematic reviews set forth by the World Workshop on Oral Medicine IV and the PRISMA statement. Eligible papers were assessed for both the degree and strength of relevance to the pathogenesis of MISGD as well as on the appropriateness of the study design and sample size. A total of 99 papers were retained for the final analysis. MISGD in human studies was generally reported as xerostomia (the sensation of oral dryness) without measurements of salivary secretion rate. Medications may act on the central nervous system (CNS) and/or at the neuroglandular junction on muscarinic, α-and β-adrenergic receptors and certain peptidergic receptors. The types of medications that were most commonly implicated for inducing salivary gland dysfunction were those acting on the nervous, cardiovascular, genitourinary, musculoskeletal, respiratory, and alimentary systems. Although many medications may affect the salivary flow rate and composition, most of the studies considered only xerostomia. Thus, further human studies are necessary to improve our understanding of the association between MISGD and the underlying pathophysiology.

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“…The incidence of taper/poststudy-emergent adverse events after the discontinuation of desvenlafaxine at 200-400 mg/day ranged from 42 to 52% [44,45]. In both studies the most common discontinuation symptoms were dizziness, nausea, and headache.…”

Section: Withdrawal Symptoms In Open Trials and Naturalistic Prospectmentioning

confidence: 99%

“…Eight open-label reports evaluated the efficacy and tolerability of venlafaxine [38,39], duloxetine [40][41][42], levomilnacipran [43], and desvenlafaxine [44,45] (online suppl. Table 3).…”

Section: Withdrawal Symptoms In Open Trials and Naturalistic Prospectmentioning

confidence: 99%

Withdrawal Symptoms after Serotonin-Noradrenaline Reuptake Inhibitor Discontinuation: Systematic Review

Fava

Benasi

Lucente

et al. 2018

Psychother Psychosom

151

146

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Background: Serotonin-noradrenaline reuptake inhibitors (SNRI) are widely used in medical practice. Their discontinuation has been associated with a wide range of symptoms. The aim of this paper is to identify the occurrence, frequency, and features of withdrawal symptoms after SNRI discontinuation. Methods: PRISMA guidelines were followed to conduct a systematic review. Electronic databases included PubMed, the Cochrane Library, Web of Science, and MEDLINE from the inception of each database to June 2017. Titles, abstracts, and topics were searched using a combination of the following terms: “duloxetine” OR “venlafaxine” OR “desvenlafaxine” OR “milnacipran” OR “levomilnacipran” OR “SNRI” OR “second generation antidepressant” OR “serotonin norepinephrine reuptake inhibitor” AND “discontinuation” OR “withdrawal” OR “rebound.” Only published trials in the English language were included. Results: Sixty-one reports met the criteria for inclusion. There were 22 double-blind randomized controlled trials, 6 studies where patients were treated in an open fashion and then randomized to a double-blind controlled phase, 8 open trials, 1 prospective naturalistic study, 1 retrospective study, and 23 case reports. Withdrawal symptoms occurred after discontinuation of any type of SNRI. The prevalence of withdrawal symptoms varied across reports and appeared to be higher with venlafaxine. Symptoms typically ensued within a few days from discontinuation and lasted a few weeks, also with gradual tapering. Late onset and/or a longer persistence of disturbances occurred as well. Conclusions: Clinicians need to add SNRI to the list of drugs potentially inducing withdrawal symptoms upon discontinuation, together with other types of psychotropic drugs. The results of this study challenge the use of SNRI as first-line treatment for mood and anxiety disorders.

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A 10-Month, Open-Label Evaluation of Desvenlafaxine in Outpatients With Major Depressive Disorder

Cited by 5 publications

References 0 publications

Safety and Tolerability of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder

Safety and Tolerability of Desvenlafaxine in Children and Adolescents with Major Depressive Disorder

World Workshop on Oral MedicineVI: a systematic review of medication‐induced salivary gland dysfunction

Withdrawal Symptoms after Serotonin-Noradrenaline Reuptake Inhibitor Discontinuation: Systematic Review

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