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Between February 2005 and April 2006, we recruited 24 adults with DSM-IV dysthymia or dysthymia and concurrent major depression ("double depression") who had an entry score of > or = 17 on the clinician-rated Inventory for Depressive Symptomatology (IDS-C). We excluded subjects with significant medical illnesses and those requiring other psychotropic agents or undergoing psychotherapy. Subjects received duloxetine 60 mg/day for 6 weeks, increased as tolerated to 120 mg/day for the remainder of the 12-week trial for those with an inadequate treatment response.
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The treatment of neuropathic pain with antidepressants has a long history. Early studies were contradictory and were limited by small numbers of patients. When evaluated meta-analytically, these studies indicated that antidepressants do have efficacy for neuropathic pain. However, none of the antidepressants used in these studies have gained approval by the US Food and Drug Administration (FDA) for this indication, and were generally associated with a high side-effect burden. Recently, duloxetine, a dual-action reuptake inhibitor, has demonstrated significant efficacy in the management of diabetic peripheral neuropathic pain in three double-blind, placebo-controlled trials and was approved by the FDA for this indication. These studies are discussed in this article.
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Various antidepressants are commonly used for the treatment of depression and several other neuropsychiatric disorders. In addition to their primary effects on serotonergic or noradrenergic neurotransmitter systems, antidepressants have been shown to interact with several receptors and ion channels. However, the molecular mechanisms that underlie the effects of antidepressants have not yet been sufficiently clarified. G protein-activated inwardly rectifying K(+) (GIRK, Kir3) channels play an important role in regulating neuronal excitability and heart rate, and GIRK channel modulation has been suggested to have therapeutic potential for several neuropsychiatric disorders and cardiac arrhythmias. In the present study, we investigated the effects of various classes of antidepressants on GIRK channels using the Xenopus oocyte expression assay. In oocytes injected with mRNA for GIRK1/GIRK2 or GIRK1/GIRK4 subunits, extracellular application of sertraline, duloxetine, and amoxapine effectively reduced GIRK currents, whereas nefazodone, venlafaxine, mianserin, and mirtazapine weakly inhibited GIRK currents even at toxic levels. The inhibitory effects were concentration-dependent, with various degrees of potency and effectiveness. Furthermore, the effects of sertraline were voltage-independent and time-independent during each voltage pulse, whereas the effects of duloxetine were voltage-dependent with weaker inhibition with negative membrane potentials and time-dependent with a gradual decrease in each voltage pulse. However, Kir2.1 channels were insensitive to all of the drugs. Moreover, the GIRK currents induced by ethanol were inhibited by sertraline but not by intracellularly applied sertraline. The present results suggest that GIRK channel inhibition may reveal a novel characteristic of the commonly used antidepressants, particularly sertraline, and contributes to some of the therapeutic effects and adverse effects.
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A systematic literature search identified relevant, randomized controlled trials (RCTs) for the treatment of CIPN. Primary outcomes included incidence and severity of neuropathy as measured by neurophysiologic changes, patient-reported outcomes, and quality of life.
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This study is the first to directly compare the relative effects of duloxetine, escitalopram, and sertraline on the functional activity of the drug-metabolizing cytochrome P450 2D6 enzyme as assessed by changes in the pharmacokinetics of the cytochrome P450 2D6 model substrate drug, metoprolol. Single-dose pharmacokinetics of metoprolol were measured before and after 17 days of treatment with escitalopram 20 mg/d, duloxetine 60 mg/d, or sertraline 100 mg/d in young healthy male and female participants. The outcome measures were changes in metoprolol peak plasma levels, area under the plasma concentration-time curve, and clearance. The results were tested using paired t tests and independent t tests. The addition of each drug produced statistically significant changes in metoprolol pharmacokinetics. The rank order for the change in metoprolol area under the plasma concentration-time curve was duloxetine (180%) > escitalopram (89%) > sertraline (48% and 67%). Compared with sertraline, duloxetine produced statistically significantly larger changes in metoprolol pharmacokinetic parameters. The changes produced by escitalopram and sertraline were not statistically different.
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We retrospectively reviewed a state poison system's database for all single agent exposures to duloxetine from 2004-2011. Data collected included age, gender, circumstances surrounding exposure, symptoms, and outcome. Patients with co-ingestants, confirmed non-exposure, unknown outcomes, or other coding errors were excluded.
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Conclusions are limited by a lack of supporting clinical information and may not apply to patients who are not privately insured.
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Se utilizó un modelo de decisión a 12 semanas para examinar el tratamiento de primera línea para la neuropatía diabética periférica dolorosa, con dosis diarias de duloxetina 60 mg o con pregabalina 300 mg, bajo la perspectiva del Instituto Venezolano de los Seguros Sociales. Los parámetros del modelo proceden de literatura publicada y opinión de expertos, enfocándose en la magnitud del alivio del dolor, la presencia de eventos adversos, la posibilidad de abandono debido a eventos adversos intolerables o por falta de eficacia y en los años de vida ajustados por calidad esperados con cada estrategia. Se analizaron los costos médicos directos (expresados en bolívares fuertes), integrados por la adquisición de medicamentos, además del cuidado adicional que se origina por el tratamiento de los eventos adversos y como consecuencia de un pobre alivio del dolor. Se llevaron a cabo análisis de sensibilidad de tipo determinístico y probabilístico.
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In this randomized controlled trial 75 patients with major depression were allocated to fixed duloxetine and either a chronotherapeutic intervention (wake group) with three initial wake therapies, daily bright light therapy, and sleep time stabilization or to a group using daily exercise. Patients were followed 29 weeks. We report the last 20 weeks, a follow-up phase, where medication could be altered. Patients were assessed every 4 weeks. Remission rates were primary outcome.
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The case definition included a predominant symptom of stress urinary incontinence with a weekly incontinence episode frequency > or =7, the absence of predominant symptoms of urge incontinence, normal diurnal and nocturnal frequencies, a bladder capacity > or =400 mL and both a positive cough stress test and positive stress pad test. Subjects completed two urinary diaries prior to randomisation and three diaries during the active treatment phase of the study, each completed during the week prior to monthly visits. Subjects also completed quality of life questionnaires at each visit. Safety was assessed by the evaluation of treatment-emergent adverse events, discontinuation of treatment because of adverse events, serious adverse events, vital sign measurements, electrocardiograms (ECG) and clinical laboratory tests.
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Brain-Derived Neurotrophic Factor (BDNF) has a central role in neuronal survival, differentiation, and plasticity. The brain level of BDNF is changed by several mood stabilizers and antidepressant drugs acting on neurotransmitters such as noradrenaline and serotonin. We investigated the effects of acute and chronic treatment with Duloxetine, a new drug blocking the re-uptake of serotonin and noradrenaline (SNRI), on BDNF level in the prefrontal cortex, cerebrospinal fluid, plasma, and serum.
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The studies described here are the first to report the pharmacokinetics of oral duloxetine in dogs, and these findings provide important information for pharmaceutical formulation research of duloxetine using dogs.
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159 cases were identified. 106 were included for review. Of 61 pediatric and adolescent cases (0-19 years old) identified, 53 involved unintentional overdose. Three patients experienced symptoms and none were admitted. All intentional ingestions(8) were seen in the emergency department, two patients experienced symptoms. No intentional ingestion was admitted for medical care. Fifty-one adult cases were included for review. Four adult patients were admitted following intentional duloxetine overdose with resolution of symptoms within 24 hours. Three adults were evaluated in a HCF following non-self-harm exposures to duloxetine. None of these patients were admitted. The remaining 15 adult patients with non-self-harm exposures were safely managed at home.
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This analysis suggests that escitalopram was more effective in terms of QALWs and less costly than duloxetine for treatment of depression.
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The derived models, although of limited value for predicting remission in individual patients, may be useful for adjusting for placebo effects in clinical trials.
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The effects of duloxetine were examined on cloned Kv4.3 channels stably expressed in CHO cells using the whole-cell patch-clamp technique. Duloxetine decreased the peak amplitude of Kv4.3 currents with an acceleration of the decay rate of current inactivation in a concentration-dependent manner. The IC(50) values required for the blocking effects of duloxetine on the peak amplitude and the integral of currents were 8.4 and 2.1μM, respectively. Duloxetine accelerated the rate of inactivation of Kv4.3 currents and thereby decreased the time-to-peak in a concentration-dependent manner. Analysis of the time dependence of the drug block produced estimates of 21.9μM(-1)s(-1) and 165.9s(-1), for the respective association (k(+1)) and dissociation (k(-1)) rate constants. The K(d) value (k(-1)/k(+1)) yielded 7.5μM, which approximates the experimental IC(50) value obtained from the concentration-response curve. The block of Kv4.3 by duloxetine was voltage-dependent at a membrane potential coinciding with the activation of the channels. At a more positive potential, however, the block was relieved. Duloxetine produced a hyperpolarizing shift in the voltage dependence of the steady-state inactivation of Kv4.3, and accelerated the closed-state inactivation of Kv4.3 in the subthreshold voltage range. Duloxetine induced a significant use-dependent block at frequencies of 1 and 2Hz. In the presence of duloxetine, the recovery from inactivation was slower than under control conditions. These results demonstrate that duloxetine exerts a concentration-dependent block of Kv4.3 by binding to the channels in the open and inactivated states and these actions may contribute to its analgesic effect in neuropathic pain.
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This research explores the social factors influencing hospital physicians' initial adoption of duloxetine hydrochloride, with a focus on colleague interactions. The study analyzes archival data compiled by the National Health Insurance Research Database of Taiwan to examine how the prescribing decisions made by psychiatrists' colleagues influence the likelihood of the psychiatrists' initial prescription. The results show that the adoption ratio of a physician's colleagues in a medical center is positively associated with the likelihood of a physician's adoption of the new drug. Specifically, colleague groups with similar and longer tenure as well as similar and older age have significantly positive effects. Colleague groups with the same and different gender also have positive effects. In summary, tenure and age, rather than gender, are vital sources of heterogeneous colleague interactions.
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Mental illness has been observed to follow a neuroprogressive course, commencing with prodrome, then onset, recurrence and finally chronic illness. In bipolar disorder and schizophrenia responsiveness to treatment mirrors these stages of illness progression, with greater response to treatment in the earlier stages of illness and greater treatment resistance in chronic late stage illness. Using data from 5627 participants in 15 controlled trials of duloxetine, comparator arm (paroxetine, venlafaxine, escitalopram) or placebo for the treatment of an acute depressive episode, the relationship between treatment response and number of previous depressive episodes was determined. Data was dichotomised for comparisons between participants who had >3 previous episodes (n=1697) or ≤3 previous episodes (n=3930), and additionally for no previous episodes (n=1381) or at least one previous episode (n=4246). Analyses were conducted by study arm for each clinical trial, and results were then pooled. There was no significant difference between treatment response and number of previous depressive episodes. This unexpected finding suggests that treatments to reduce symptoms of depression during acute illness do not lose efficacy for patients with a longer history of illness.
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To determine the effect of duloxetine, 60 mg daily, on average pain severity.