Side Effects Of Antidepressants Research Articles

Monitoring Adverse Effects of Antipsychotics and Antidepressants: A Population Based Study

Abstract: Aim: To monitor the nature and incidences adverse effects of both antipsychotics and antidepressants medicines in the psychiatry outpatient department. Objectives: Reporting the incidences of adverse effects and to establish the frequency of a specific class of drug. Identifying the system affected and the assessment of the management of the adverse effects by the physician. For the study, we have adopted Global Assessment Scale (GAS), Simpson-Angus Extra pyramidal Side Effects Scale (SAS) and The Antidepressant Side-Effect Checklist (ASEC). Materials and Methods: A prospective cohort study carried out in the psychiatry out-patient department. All the patients attending psychiatry outpatient department enrolled based on the pre-specified inclusion criteria and monitored for adverse effects. Causality also assessed by WHO-UMC causality assessment system and Naranjo Causality Assessment. Results: The incidence rate of adverse effects (46.07%) and 560 adverse effects documented. Weight gain (n=29, 9.2%) followed by drowsiness (n=27, 4.82%) are most commonly reported adverse effects. Atypical antipsychotics (n=279, 49.82%) were the most common class of psychotropic drugs implicated in adverse effects. Escitalopram (n=93, 37.80%) followed by olanzapine (n=53, 21.54%) associated with a maximum number of adverse effects. Central nervous system (n=225, 40.17%) was the most affected organ system followed by gastrointestinal system (n=130, 23.21%). Conclusion: Study revealed moderate incidences of adverse effects in patients attending the psychiatry outpatient department. Majority of the adverse effects reported during the study were mild in nature and not preventable. The role of a clinical pharmacist clearly elucidated regular intensive monitoring of adverse effects may improve the quality of patients’ care, reduction in the treatment cost and augmentation of the medication adherence among patients. Key words: Adverse effects, Pharmacovigilance, Antipsychotics, Antidepressants, Extra pyramidal side effects.

Antidepressant side effects and their impact on treatment outcome in people with major depressive disorder: an iSPOT-D report

Side effects to antidepressant medications are common and can impact the prognosis of successful treatment outcome in people with major depressive disorder (MDD). However, few studies have investigated the severity of side effects over the course of treatment and their association with treatment outcome. Here we assessed the severity of side effects and the impact of treatment type and anxiety symptoms over the course of treatment, as well as whether side effects were associated with treatment outcome. Participants were N = 1008 adults with a current diagnosis of single-episode or recurrent, nonpsychotic MDD. Participants were randomised to receive escitalopram, sertraline, or venlafaxine-extended release with equal probability and reassessed at 8 weeks regarding Hamilton Rating Scale Depression (HRSD17) and Quick Inventory of Depressive Symptomatology (QIDS-SR16) remission and response. Severity of side effects were assessed using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) scale and assessed at day 4 and weeks 2, 4, 6, and 8. Frequency, intensity, and burden of side effects were greatest at week 2, then only frequency and intensity of side effects gradually decreased up to week 6. Treatment type and anxiety symptoms did not impact the severity of side effects. A greater burden—but not frequency or intensity—of side effects was associated with poorer treatment outcome and as early as 4 days post-treatment. Together, this work provides an informative mapping of the progression of side effects throughout the treatment course and their association with treatment outcome. Importantly, the burden of side effects that are present as early as 4 days post-treatment predicts poorer treatment outcome and should be monitored closely. iSPOT-D: Registry name: ClinicalTrials.gov. Registration number: NCT00693849.

Kleptomania, a symptom of depression or frontotemporal dementia?

Three patients were presented in order to make differential diagnosis between affective disorder and dementia. All patients have diagnosis of affective disorder and they were in stable remission under antidepressive therapy. When pathological stealing occurred, there was a diagnostic dilemma: is it a new manifestation of affective disorder, rare side effect of serotonergic antidepressants or symptom of dementia. Neuroimaging methods, as well as neuropsychological testing identified that in these patients other symptoms of prefrontal dementia also existed. Frontotemporal dementia (FTD) is frequently misdiagnosed with depression, and so far, inadequately treated with higher doses of antidepressants. Such therapy could worsen clinical feature. These patients were successfully treated with combination of memantine and low doses of serotonergic antidepressants. In the future, multicentric investigation should be conducted to confirm effective therapeutic combination of psychopharmacs in cases of pathological stealing in FTD.

Impact of childhood maltreatment on outcomes of antidepressant medication in chronic and/or recurrent depression

BackgroundWhile childhood maltreatment (CMT) is associated with higher rates of chronicity and recurrence in depression, whether CMT results in poorer outcomes with antidepressant medication remains unclear. MethodsWe performed secondary analyses with data from the large, representative, multisite trial Combining Medications to Enhance Depression Outcomes (CO-MED). CO-MED was a randomized, single-blinded, placebo-controlled study with 665 individuals (663 assessed for CMT) with chronic and/or recurrent Major Depressive Disorder (MDD). CMT was determined by a brief self-reported questionnaire assessing the four types of CMT defined by the Centers for Disease Control and Prevention: sexual abuse, emotional abuse, physical abuse, and neglect. Repeated measures and logistic regression analyses were used. ResultsIndividuals with CMT did not have a differential improvement of depressive symptoms when compared to those without CMT (adjusted p=.203 for continuous analysis; adjusted p=.320 for remission rates). Neither type of antidepressant medication (adjusted p=.302) nor the age at which CMT occurred (adjusted p=.509) affected depressive symptom outcomes. There was no difference in functional improvement between individuals with and without CMT (adjusted p=.228). A history of CMT was associated with greater antidepressant side effects (p=.009). LimitationsThis study investigated treatment-seeking individuals with chronic and/or recurrent MDD. Intensity and duration of CMT were not assessed. ConclusionIn a sample of treatment-seeking outpatients with chronic and/or recurrent MDD, a history of CMT was not associated with differential symptomatic or functional response to pharmacological treatment. However, those with CMT reported greater antidepressant side effect burden.

Do side effects of antidepressants impact efficacy estimates based on the Hamilton Depression Rating Scale? A pooled patient-level analysis

The Hamilton Depression Rating Scale (HDRS-17) measures symptoms that may overlap with common antidepressant side effects (e.g., sexual dysfunction), thus making it possible that side effects of antidepressant treatment are erroneously rated as symptoms of depression, and vice versa. This study uses patient-level data from previously conducted antidepressant treatment trials to assess whether side effect ratings co-vary with HDRS-17 ratings. Data from all HDRS-17-rated, industry-sponsored pre- and post-marketing trials (n = 4647) comparing the serotonin and noradrenaline reuptake inhibitor, duloxetine, to placebo and/or to a selective serotonin reuptake inhibitor were pooled; three studies, which utilised sub-therapeutic doses, did not have symptom-level ratings available and could not be included. Severity was assessed for side effects related to sleep, somatic anxiety, gastrointestinal function, and sexual dysfunction. Analysis of covariance was used to assess the relation between these side effects and ratings of relevant HDRS-17-derived outcome parameters. Side effects related to sleep, somatic anxiety and sexual dysfunction significantly and exclusively associated with higher scores on HDRS-17 items measuring the corresponding domains. Side effects related to gastrointestinal function associated with higher HDRS-17 item scores on all assessed domains. Treatment outcome was significantly related to side effect severity when assessed using HDRS-17-sum (beta 0.32 (0.074), p < 0.001), but not when the HDRS-6-sum-score (beta 0.035 (0.043), p = 0.415) or the depressed mood item (beta 0.007 (0.012), p = .527) were used as effect parameters. That some HDRS-17 items co-vary with common antidepressant side effects suggests some of these adverse events are counted twice, potentially leading to an underestimation of antidepressant efficacy.

Informing About the Nocebo Effect Affects Patients' Need for Information About Antidepressants-An Experimental Online Study.

Relevance: Understanding patients’ informational needs and adapting drug-related information are the prerequisites for a contextualized informed consent. Current information practices might rather harm by inducing nocebo effects.Objective: To investigate whether informing about the nocebo effect using a short information sheet affects patients’ need for information about antidepressants.Methods: A total of 97 patients taking recently prescribed antidepressants (≤4 months intake) were recruited over the internet and randomized to receiving either a one-page written information about the nocebo effect or a control text about the history of antidepressants. After experimental manipulation, informational needs about the side effects and mechanisms of antidepressants were assessed with 3 and 7 items on categorical and 5-point Likert scales. Group differences in informational needs were calculated with Chi-square tests and ANOVAs.Results: Patients received antidepressants for depression (84.5%) and/or anxiety disorders (42.3%). Three participants (6.0%) of the nocebo group reported previous knowledge of the nocebo effect. After the experimental manipulation, participants in the nocebo group reported a reduced desire for receiving full side effect information [ = 12.714, Cramer’s V = 0.362, p = 0.013] and agreed more frequently to the usefulness of withholding information about possible side effects [ = 14.878, Cramer’s V = 0.392, p = 0.005]. Furthermore, they desired more information about the mechanisms of antidepressants (F = 6.373, p = 0.013, partial η2 = 0.063) and, specifically, non-pharmacological mechanisms, such as the role of positive expectations (F = 16.857, p < 0.001, partial η2 = 0.151).Conclusions: Learning about the nocebo effect can alter patients’ informational needs toward desiring less information about the potential side effects of antidepressants and more information about general mechanisms, such as expectations. The beneficial effects of including nocebo information into contextualized informed consent should be studied clinically concerning more functional information-seeking behavior, which may ultimately lead to improved treatment outcomes, such as better adherence and reduced side effect burden.

Understanding Side Effects of Antidepressants: Large-scale Longitudinal Study on Social Media Data.

BackgroundAntidepressants are known to show heterogeneous effects across individuals and conditions, posing challenges to understanding their efficacy in mental health treatment. Social media platforms enable individuals to share their day-to-day concerns with others and thereby can function as unobtrusive, large-scale, and naturalistic data sources to study the longitudinal behavior of individuals taking antidepressants.ObjectiveWe aim to understand the side effects of antidepressants from naturalistic expressions of individuals on social media.MethodsOn a large-scale Twitter data set of individuals who self-reported using antidepressants, a quasi-experimental study using unsupervised language analysis was conducted to extract keywords that distinguish individuals who improved and who did not improve following the use of antidepressants. The net data set consists of over 8 million Twitter posts made by over 300,000 users in a 4-year period between January 1, 2014, and February 15, 2018.ResultsFive major side effects of antidepressants were studied: sleep, weight, eating, pain, and sexual issues. Social media language revealed keywords related to these side effects. In particular, antidepressants were found to show a spectrum of effects from decrease to increase in each of these side effects.ConclusionsThis work enhances the understanding of the side effects of antidepressants by identifying distinct linguistic markers in the longitudinal social media data of individuals showing the most and least improvement following the self-reported intake of antidepressants. One implication of this work concerns the potential of social media data as an effective means to support digital pharmacovigilance and digital therapeutics. These results can inform clinicians in tailoring their discussion and assessment of side effects and inform patients about what to potentially expect and what may or may not be within the realm of normal aftereffects of antidepressants.

Effects of celecoxib augmentation of antidepressant or anxiolytic treatment on affective symptoms and inflammatory markers in patients with anxiety disorders: exploratory study

Prolonged stress has been associated with elevated levels of circulating proinflammatory cytokines. Cyclo-oxygenase-2 inhibitors such as celecoxib exert anti-inflammatory effects and may enhance the response to antidepressant drug treatment in patients with depressive disorders, but their effect on anxiety symptoms in patients with anxiety disorders is uncertain. Patients with a primary diagnosis of an anxiety disorder, with stabilised symptoms, underwent either 6 weeks of celecoxib augmentation of continued treatment (n = 18) or continued 'treatment as usual' (n = 9). Assessments included the Warwick-Edinburgh mental well-being Scale (WEMWEBS), Hospital Anxiety and Depression Scale (HADS), Oxford questionnaire of emotional side effects of antidepressants (OQUESA) and Clinical Global Impression of Illness Severity (CGI-S). Venous blood samples were collected for assays of inflammatory cytokines. Patients who underwent celecoxib augmentation showed significant reductions in anxiety (HADS-A -3.17) and depressive (HADS-D -2.11) symptoms and in overall illness severity (CGI-S -1.11), and improvements in mental well-being (WEMWBS 7.5) and positive changes in emotional responsiveness (OQUESA-RP -3.56; OQUESA-AC -4.22): these were not seen with 'treatment as usual'. There were no significant changes in blood levels of inflammatory cytokines in either group. Celecoxib augmentation appeared associated with beneficial effects on anxiety and depressive symptoms and mental well-being. The findings from this pilot study merit further exploration within a double-blind, randomised placebo-controlled study.

Antidepressants’ effects on testosterone and estrogens: What do we know?

Various antidepressants are commonly used to treat depression and anxiety disorders, and sex differences have been identified in their efficacy and side effects. Steroids, such as estrogens and testosterone, both in the periphery and locally in the brain, are regarded as important modulators of these sex differences. This review presents published data from preclinical and clinical studies that measure testosterone and estrogen level changes during and/or after acute or chronic administration of different antidepressants. The majority of studies show an interaction between sex hormones and antidepressants on sexual function and behavior, or in depressive symptom alleviation. However, most of the studies omit to investigate antidepressants’ effects on circulating levels of gonadal hormones. From data reviewed herein, it is evident that most antidepressants can influence testosterone and estrogen levels. Still, the evidence is conflicting with some studies showing an increase, others decrease or no effect. Most studies are conducted in male animals or humans, underscoring the importance of considering sex as an important variable in such investigations, especially as depression and anxiety disorders are more common in women than men. Therefore, research is needed to elucidate the extent to which antidepressants can influence both peripheral and brain levels of testosterone and estrogens, in males and females, and whether this impacts the effectiveness or side effects of antidepressants.

Depression therapy for somatic diseases

A review of works devoted to the problem of psychopharmacotherapy of depression in general medical practice is presented. The issues of its comorbidity with somatic and neurological diseases, as well as multimorbidity are discussed. Both direct and side-effects of antidepressants, which are important for effective therapy of not only affective disorders proper, but also the symptoms of the leading pathology, are considered in detail for individual organs and systems. The analysis of the preferred pharmacological classes of antidepressants, which are drugs of first choice, taking into account the somatic condition of the patient, is carried out, and drugs are indicated, the appointment of which is undesirable for the treatment of a patient with a certain disease. The presented results are aimed both at increasing the efficiency of therapy for patients with general medical level of health care, and at increasing the safety of treatment of psychiatric patients with concomitant somatic disorders.

Do Newer Antidepressant Drugs Really Have Reduced Side Effects? Examining a Random “Real World” Sample of 300+ Receivers of Medications

Newer antidepressant drugs are frequently cited as having reduced side effect profiles to that of their older counterparts. However, recent studies have begun to dispute this claim, citing selective sampling, short clinical trials, and clinical trial environments as influencing reported outcomes. At present, little research on antidepressant side effects draws on RWD (Real-World Data). Despite this, interest in examining RWD samples for antidepressant drug side effects is increasing as of 2020. The reported study asked a random sample of 300+ individuals taking a variety of different antidepressant medications to complete online drug side effect self-report scales with previously high validity. Newer antidepressants belonging to the atypical antidepressant drug class were reported as having only slightly reduced side effects of weight gain compared with older SSRI-class medications. No reduced side effects of increased depression, anxiety, sexual dysfunction (SD), sleepiness, or suicidal ideation (SI) were found for the newer atypical-class medications vs older SSRI-class agents. Medication adherence did not differ significantly between SSRI and atypical classes. No evidence for reduced side effects was found for newer SSRI and atypical antidepressants vs older same-class drugs when comparing six new and old medications drawn from atypical and SSRI classes. However, atypical antidepressants were associated with increased use of adjunct medications to bolster primary treatment.

Acceptability, Feasibility, and Utility of Integrating Pharmacogenetic Testing into a Child Psychiatry Clinic.

Pharmacogenetic (PGx) testing is a tool to identify patients at a higher risk of adverse events or treatment failure. The concern for unwanted side effects can limit medication adherence, particularly in children and adolescents. We conducted a pragmatic study to evaluate the acceptability and feasibility and gather pilot data on the utility of PGx testing in a child and adolescent psychiatry clinic. Both physicians and families participated in the study and answered pre‐survey and post‐survey questionnaires to examine their attitudes toward PGx testing. Patients were randomized into implementation (N = 25) and control groups (N = 24) and underwent PGx testing at the beginning or end of the study, respectively. Clinical consult notes with genotype‐guided recommendations were provided to physicians for their consideration in clinical decisions. Patient‐reported symptom severity and antidepressant‐related side effects were assessed at baseline and for 12 weeks. Both participating physicians and families agreed that PGx testing is a useful tool to improve medication selection. The time from sample collection to having PGx test results was ~ 10 days and 15 days to having consult notes available, which may have impaired test utility in clinical decision making. There were no differences in any clinical end point between the implementation and control arms; however, there were higher antidepressant side effect scores for CYP2D6 poor and intermediate metabolizers after the eighth week of treatment. Our findings revealed benefits and pitfalls with the use of PGx testing in the real‐world clinical setting, which may inform the methodology of a larger trial focused on outcomes.

Evaluation of Emotional Adverse Effects of Antidepressants: A Follow-up Study.

Emotional adverse effects due to antidepressant use may cause difficulties for the clinician in the treatment of depression. In this prospective study, the emotional adverse effects of antidepressants were evaluated in various aspects. Ninety eight patients diagnosed with major depressive disorder were included in the study. At 2nd, 4th, 8th, 12th, and 16th weeks, patients were assessed with Montgomery-Asberg Depression Rating Scale (MADRS), and the antidepressant dose was increased in patients with less than a 50% reduction at each visit compared with the initial MADRS score. The Oxford Questionnaire on the Emotional Side-effects of Antidepressants (OQESA) was used at the 8th-week and 16th-week visits. A significant difference is found in the OQESA score at the 8th-week visit compared with the 16th-week assessment (P < 0.001, t = 5.73). There were significant correlations between MADRS scores and OQESA scores both at the 8th (r = 0.346, P = 0.05) and the 16th (r = 0.490, P < 0.001) weeks. In regression analyses, at eighth-week assessment, MADRS score (B = 1.487, P = 0.002) and selective serotonin reuptake inhibitor use (B = 14.014, P = 0.023) had a significantly predicted OQESA score. In this study, it is found that, as the rate of remitted patients is increased, OQESA scores get decreased, and furthermore, the OQESA score of the remitted group is statistically low when compared with that of the nonremitted group at the 8th- and 16th-week visits. Oxford Questionnaire on the Emotional Side-effects of Antidepressants and MADRS scores are significantly correlated in all assessments. These results suggest that the score obtained from OQESA may be related not only to the emotional adverse effects of antidepressants but also to the residual symptoms of depression.

Associations between the 1438A/G, 102T/C, and rs7997012G/A polymorphisms of HTR2A and the safety and efficacy of antidepressants in depression: a meta-analysis.

The correlations between hydroxytryptamine receptor 2A (HTR2A) gene polymorphisms (1438A/G, 102T/C, and rs7997012G/A) and the safety and efficacy of antidepressants in depression patients were constantly reported, but conclusions are debatable. This meta-analysis ascertained forty-two studies on the efficacy (including response and remission) and side-effect issued before February 2020. Pooled analyses indicated significant associations of 1438A/G polymorphism (16 studies, 1931 subjects) and higher response within dominant model (OR: 1.40, 95% CI: 1.12-1.76); rs7997012G/A polymorphism (nine studies, 1434 subjects) and higher remission in overall models (dominant model: OR: 1.30, 95% CI: 1.01-1.66; recessive model: OR: 2.20, 95% CI: 1.53-3.16; homozygote model: OR: 2.73, 95% CI: 1.78-4.17); 102T/C polymorphism (eight studies, 804 subjects) and reduced risk of side-effect within recessive (OR: 0.57, 95% CI: 0.4-0.83) and homozygote models (OR: 0.54, 95% CI: 0.29-0.99). For depression patients, genotyping of HTR2A polymorphisms is a promising tool for estimating the outcome and side-effect of antidepressants.

Self-Reported Antidepressant Drug Side Effects, Medication Adherence, and Its Associated Factors among Patients Diagnosed with Depression at the Psychiatric Hospital of Nepal.

Objective The present study is aimed at evaluating the side effects of antidepressant drugs, medication adherence (MA), and associated factors among patients diagnosed with depression at a psychiatric hospital in western Nepal. Methods A prospective cross-sectional study was conducted among 174 patients visiting the outpatient clinic of a psychiatric hospital. The antidepressant side effect checklist (ASEC) was used to classify the reported antidepressant drug side effects into mild, moderate, and severe types. The Naranjo adverse drug reaction (ADR) probability scale was employed to assess the ADRs, and the Morisky Green Levine Adherence (MGLA) score was employed to determine the rate of medication adherence. Descriptive statistics and bivariate analysis were used, and a P value < 0.05 was taken as statistically significant in the multivariate analysis. Results The patients were mostly female (55.74%), with a median (IQR) age of 32 (20) years. Approximately 74.13% of the patients experienced antidepressant side effects, where insomnia (17.05%) and anxiety (17.05%) were the most common. More than half of the patients (52.29%) had a low level of adherence. Females were 1.01 times more likely to be nonadherent to their antidepressant medications compared to males, adjusted odds ratio (AOR): 1.001 (0.31-1.63). Similarly, illiterate patients tended to be more nonadherent compared to literates, AOR: 1.342 (0. 93-2.82), and unemployed individuals were 1.5 times more likely to be nonadherent to their medications compared to employed individuals, AOR: 1.46 (1.16-4.13). Likewise, patients with severe side effects were more prone to develop nonadherence than those with moderate side effects, AOR: 1.173 (0.42-3.25). A significant association was found between the Naranjo score and medication adherence. Conclusions This study suggests that antidepressant drug side effects were more prevalent and medication adherence was extremely poor among depressive patients in psychiatric hospitals. Factors such as gender, occupation, education, side effects, and ADRs attributed to poor medication adherence in patients.

Pharmacogenetics and therapeutic drug monitoring of fluoxetine in a real-world setting: A PK/PD analysis of the influence of (non-)genetic factors.

This work presents the GnG-PK/PD-AD study-a pharmacokinetics/pharmacodynamics (PK/PD) analysis of the impact of genetic and nongenetic factors on the treatment with the antidepressant fluoxetine (FLU)-with a focus on potential biomarkers. Seventy-nine depressed patients treated with FLU were recruited and clinically characterized in the scope of the study. Clinical outcomes, including remission and antidepressant adverse effects were assessed by means of the Hamilton Depression Rating Scale and the Antidepressant Side-Effect Checklist, respectively. Patients were submitted to therapeutic drug monitoring of FLU and norfluoxetine and genotyping of the CYP2C9, CYP2C19, CYP2D6, and ABCB1 genes. A multivariate analysis was used to evaluate the impact of genetic and nongenetic factors on the drug plasma concentrations and clinical outcomes and to identify potential biomarkers. Genetically determined CYP2D6 activity was found to be a predictor of FLU and norfluoxetine concentrations (p < .05). In turn, genetic and nongenetic factors related to CYP2D6 and P-glycoprotein were found as potential biomarkers of the clinical outcomes of FLU (p < .05). Specifically, the potential of the CYP2D6 to be inhibited by drug-induced phenoconversion was associated with a higher severity of depression (p < .05). Moreover, ABCB1 TTT-haplotype was favorable to better clinical outcomes with FLU (higher likelihood of remission and lower severity of adverse effects; p < .05). The potential of the P-glycoprotein to be inhibited by drug-induced phenoconversion was also related to a worse tolerability profile (higher severity and number of adverse effects; p < .05). Lastly, the presence of nervous system comorbidities was associated with a higher severity of adverse effects and aging and the female gender with a higher severity of depression and lower probability of remission (p < .05). (PsycInfo Database Record (c) 2020 APA, all rights reserved).

POSSIBLE COMPLICATIONS OF ANTIDEPRESSANTS AND THEIR CORRECTION

Depression and the complications of its pharmacotherapy remain relevant issues in modern medicine. Since the advent of the first antidepressants, more than 60 years ago, to the present, their arsenal has expanded significantly. On the one hand, the emergence of new antidepressants is a great achievement in psychopharmacology, and on the other hand, due to their specificity, antidepressants cause many complications. In addition, in recent years, the list of diseases in which off label (outside the instructions) use these drugs has expanded significantly, and given the fact that for these diseases, anti-depressants are prescribed in combination with other drugs, so the risk of developing side effects increases significantly . This article analyzes the frequently encountered side effects of antidepressants, the mechanisms of their occurrence when using both first-generation antidepressants (three and tetracyclic antidepressants, monoamine oxidase inhibitors) and newer drugs from the group of selective serotonin reuptake inhibitors. The conditions for the rational use of antidepressants are also presented, which allows to optimize their use and the safety of pharmacotherapy for depression. Thus, today it is necessary to create new safer antidepressants that selectively inhibit the reuptake of one of monoamines (for example, serotonin) and third-generation drugs with a “double” effect, i. e. selectively and equipotentially inhibiting the reuptake of serotonin and norepinephrine.

Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study: a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial

IntroductionDepression is a highly prevalent condition in the elderly, with a vast impact on quality of life, life expectancy, and medical outcomes. Selective serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed agents in this condition and, although generally safe, tolerability issues cannot be overlooked. Vortioxetine is an antidepressant with a novel mechanism of action. Based on studies to date, it may have a promising tolerability profile in the elderly, as it does not adversely affect psychomotor or cognitive performance and does not alter cardiovascular and endocrine parameters. The present study aims to assess the tolerability profile of vortioxetine in comparison with the SSRIs considered as a single group in elderly participants with depression. The rate of participants withdrawing from treatment due to adverse events after 6 months of follow up will be the primary outcome.Methods and analysisThis is a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial funded by the Italian Medicines Agency (AIFA - Agenzia Italiana del Farmaco). Thirteen Italian Community Psychiatric Services will consecutively enrol elderly participants suffering from an episode of major depression over a period of 12 months. Participants will be assessed at baseline and after 1, 3 and 6 months of follow up. At each time point, the following validated rating scales will be administered: Montgomery–Åsberg Depression Rating Scale (MADRS), Antidepressant Side-Effect Checklist (ASEC), EuroQual 5 Dimensions (EQ-5D), Short Blessed Test (SBT), and Charlson Age-Comorbidity Index (CACI). Outcome assessors and the statistician will be masked to treatment allocation. A total of 358 participants (179 in each group) will be enrolled.Ethics and disseminationThis study will fully adhere to the ICH E6 Guideline for Good Clinical Practice. Participants’ data will be managed and safeguarded according to the European Data Protection Regulation 2016/679. An external Ethical Advisory Board will help guarantee high ethical standards.Trial registrationClinicaltrials.gov: NCT03779789, Registered on 19 December 2018. Submitted on 19 December. EudraCT number: 2018–001444-66.Trial statusProtocol version 1.5; 09/06/2018. Recruitment started In February 2019 and it is ongoing. It is expected to end approximately on 30 September 2021.

Pharmacological treatment of depression in people with a primary brain tumour.

This is the second updated version of the Cochrane Review published in Issue 3, 2010 and first updated in Issue 5, 2013. People with a primary brain tumour often experience depression, for which drug treatment may be prescribed. However, they are also at high risk of epileptic seizures, cognitive impairment, and fatigue, all of which are potential adverse side effects of antidepressants. The benefit, or harm, of pharmacological treatment of depression in people with a primary brain tumour is unclear. To assess the benefits and harms of pharmacological treatment of depression in people with a primary brain tumour. We updated the search to include CENTRAL, MEDLINE, Embase, and PsycINFO to September 2019. As in the original review, we also handsearched Neuro-Oncology, Journal of Neuro-Oncology, Journal of Neurology, Neurosurgery and Psychiatry, and Journal of Clinical Oncology: for the current update we handsearched the latest three years of articles from these journals (up to November 2019). We searched for all randomised controlled trials (RCTs), controlled clinical trials, cohort studies, and case-control studies of any pharmacological treatment of depression in people with a histologically diagnosed primary brain tumour. No studies met the inclusion criteria. We found no eligible studies evaluating the benefits of any pharmacological treatment of depression in people with a primary brain tumour. We identified no high-quality studies that investigated the value of pharmacological treatment of depression in people with a primary brain tumour.RCTs and detailed prospective studies are required to inform the effective pharmacological treatment of this common and important complication of brain tumours.Since the last version of this review none of the related new literature has provided additional information to change these conclusions.

Hyponatremia due to duloxetine use in an elderly woman patient

Hyponatremia is a potentially dangerous side effect of antidepressants. Almost every antidepressant can cause hyponatremia. Duloxetine-induced hyponatremia is a side effect that is usually seen in older women. In addition to advanced age and female sex; low body weight, presence of comorbid diseases are other important risk factors for the development of hyponatremia. In this case report we present a patient with depressive disorder who developed hyponatremia with duloxetine treatment which resolved immediately after the cessation of the medication with supportive electrolyte treatment. In our case, the resolution of hyponatremia with supportive electrolyte treatment in addition to the cessation of duloxetine reminds us about the importance of monitoring sodium levels both before and after antidepressant treatment in geriatric populations.