Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study.
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ABSTRACT: Introduction
Several monoclonal antibodies (mAbs) have been linked to neuropsychiatric adverse effects in patients, including depression and suicidal ideation and behavior.Objective
The aim of this study was to quantify and characterize spontaneously reported adverse drug reactions (ADRs) of depression and suicidal ideation and behavior related to mAb users, and to explore a possible association with their mechanism of action.Methods
We included mAb ADRs that were reported in VigiBase, and identified those related to depression and suicidal ideation and behavior. Reporting odds ratios (RORs) were estimated for each mAb (bevacizumab as the reference) and according to their influence on the immune system (not directly targeting [reference], stimulating, or suppressing). Those suppressing the immune system were further divided into their intended indication (auto-immune diseases, cancer).Results
Overall, 2,924,319 ADRs for 44 mAbs were included; 9455 ADRs were related to depression and 1770 were related to suicidal ideation and behavior. The association was strongest for natalizumab and belimumab, both for depression (ROR 5.7, 95% confidence interval [CI] 5.0-6.4; and ROR 5.1, 95% CI 4.2-6.2) and suicidal ideation and behavior (ROR 12.0, 95% CI 7.9-18.3; and ROR 20.2, 95% CI 12.4-33.0). Those suppressing the immune system showed higher ROR, i.e. 1.9 (95% CI 1.8-2.0) for depression and 3.6 (95% CI 3.0-4.4) for suicidal ideation and behavior. This finding was only seen for mAbs used for treating autoimmune diseases.Conclusion
Depression and suicidal ideation and behavior are seen in patients using mAbs, particularly mAbs used for treating autoimmune diseases that suppress the immune system. For interpretation of these data, the indications for use and other characteristics require further consideration.
SUBMITTER: Minnema LA
PROVIDER: S-EPMC6581921 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Many people use apps to help understand and manage their depression symptoms. App-administered questionnaires for the symptoms of depression, such as the Patient Health Questionnaire-9, are easy to score and implement in an app, but may not be accompanied by essential resources and access needed to provide proper support and avoid potential harm. OBJECTIVE:Our primary goal was to evaluate the differences in risks and helpfulness associated with using an app to self-diagnose depression, comparing assessment-only apps with multifeatured apps. We also investigated whether, what, and how additional app features may mitigate potential risks. METHODS:In this retrospective observational study, we identified apps in the Google Play store that provided a depression assessment as a feature and had at least five user comments. We separated apps into two categories based on those having only a depression assessment versus those that offered additional supportive features. We conducted theoretical thematic analyses over the user reviews, with thematic coding indicating the helpfulness of the app, the presence of suicidal ideation, and how and why the apps were used. We compared the results across the two categories of apps and analyzed the differences using chi-square statistical tests. RESULTS:We evaluated 6 apps; 3 provided only a depression assessment (assessment only), and 3 provided features in addition to self-assessment (multifeatured). User comments for assessment-only apps indicated significantly more suicidal ideation or self-harm (n=31, 9.4%) compared to comments for multifeatured apps (n=48, 2.3%; X21=43.88, P<.001). Users of multifeatured apps were over three times more likely than assessment-only app users to comment in favor of the app's helpfulness, likely due to features like mood tracking, journaling, and informational resources (n=56, 17% vs n=1223, 59% respectively; X21=200.36, P<.001). The number of users under the age of 18 years was significantly higher among assessment-only app users (n=40, 12%) than multifeatured app users (n=9, 0.04%; X21=189.09, P<.001). CONCLUSIONS:Apps that diagnose depression by self-assessment without context or other supportive features are more likely to be used by those under 18 years of age and more likely to be associated with increased user distress and potential harm. Depression self-assessments in apps should be implemented with caution and accompanied by evidence-based capabilities that establish proper context, increase self-empowerment, and encourage users to seek clinical diagnostics and outside help.
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| S-EPMC7178046 | biostudies-literature
Project description:Suicide is the second leading cause of death among adolescents. With every fifth Indian to be an adolescent, the cost of an adolescent dying by suicide is enormous. This necessitates an understanding of the potential risk factors of suicidal ideation among adolescents. Secondary data analysis is performed on cross-sectional survey data obtained from Understanding the Lives of Adolescents and Young Adults. The survey was conducted in two Indian states of Bihar and Uttar Pradesh. Descriptive statistics, bivariate analysis and logistic regression are done to examine the results. Adolescent girls reported more suicidal ideation than boys. The odds of suicidal ideation are significantly higher among adolescents whose mother faced physical abuse and adolescents who themselves experienced sexual abuse. Adolescent boys and girls who have moderate depressive symptoms and impulsive behavior are significantly more likely to report suicidal ideation. The results help in identifying the adolescents who are at a particular risk for suicidal ideation while planning for intervention program for prevention of suicide.
| S-EPMC8722622 | biostudies-literature
Project description:ImportanceSuicide prevention is an important component of depression management. Knowledge about depressed adolescents with increased risk for suicide can inform suicide prevention efforts.ObjectiveTo describe the risk of documented suicidal ideation within a year following a diagnosis of depression and to examine how the risk of documented suicidal ideation differed by recent violence encounter status among adolescents with new depression diagnoses.Design, setting, and participantsRetrospective cohort study in clinical settings including outpatient facilities, emergency departments, and hospitals. Using IBM's Explorys database containing electronic health records from 26 US health care networks, this study observed a cohort of adolescents with new depression diagnoses from 2017 to 2018 for up to 1 year. Data were analyzed from July 2020 to July 2021.ExposuresRecent violence encounter was defined by a diagnosis of child maltreatment (physical, sexual, or psychological abuse or neglect) or physical assault within 1 year before depression diagnosis.Main outcomes and measuresThe main outcome was diagnosis of suicidal ideation within 1 year following depression diagnosis. Multivariable adjusted risk ratios of suicidal ideation were calculated for overall recent violence encounters and for individual forms of violence.ResultsAmong a total of 24 047 adolescents with depression, 16 106 (67.0%) were female and 13 437 (55.9%) were White. A total of 378 had experienceda violence (hereafter, encounter group) and 23 669 had not (hereafter, nonencounter group). Following the diagnosis of depression, 104 adolescents with any past-year violence encounter (27.5%) documented suicidal ideation within 1 year. In contrast, 3185 adolescents in the nonencounter group (13.5%) experienced thoughts of suicide following the diagnosis of depression. In multivariable analyses, those with any violence encounter had 1.7 times (95% CI 1.4-2.0) higher risk of documented suicidal ideation compared with those in the nonencounter group (P < .001). Among different forms of violence, sexual abuse (risk ratio, 2.1; 95% CI, 1.6-2.8) and physical assault (risk ratio, 1.7; 95% CI, 1.3-2.2) were associated with significantly increased risk of suicidal ideation.Conclusions and relevanceAmong adolescents with depression, persons who experienced past-year violence encounters showed a higher rate of suicidal ideation than those who had not. These findings highlight the importance of identifying and accounting for past violence encounters when treating adolescents with depression to reduce risk of suicide. Public health approaches to prevent violence may help to avert morbidity associated with depression and suicidal ideation.
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Project description:BackgroundSleep problems and depression are highly prevalent in pregnancy. Nocturnal rumination has been linked to insomnia and depression in non-pregnant samples, but remains poorly characterized in pregnancy. This study explored relationships of depression and suicidal ideation with insomnia, short sleep, and nocturnal rumination in mid-to-late pregnancy.MethodsIn this study, 267 pregnant women were recruited from obstetric clinics and completed online surveys on sleep, depression, and nocturnal rumination.ResultsOver half (58.4%) of the sample reported clinical insomnia on the Insomnia Severity Index, 16.1% screened positive for major depression on the Edinburgh Postnatal Depression Scale (EPDS), and 10.1% endorsed suicidal ideation. Nocturnal rumination was more robustly associated with sleep onset difficulties than with sleep maintenance issues. Depressed women were at greater odds of sleep onset insomnia (OR = 2.80), sleep maintenance insomnia (OR = 6.50), high nocturnal rumination (OR = 6.50), and negative perinatal-focused rumination (OR = 2.70). Suicidal ideation was associated with depression (OR = 3.64) and negative perinatal-focused rumination (OR = 3.50). A four-group comparison based on insomnia status and high/low rumination revealed that pregnant women with insomnia and high rumination endorsed higher rates of depression (35.6%) and suicidal ideation (17.3%) than good-sleeping women with low rumination (1.2% depressed, 4.9% suicidal). Women with insomnia alone (depression: 3.9%, suicidal: 5.9%) or high rumination alone (depression: 10.7%, suicidal: 7.1%) did not differ from good-sleeping women with low rumination.ConclusionsHigh rumination and insomnia are highly common in mid-to-late pregnancy and both are associated with depression and suicidal ideation. Depression and suicidal ideation are most prevalent in pregnant women with both insomnia and high rumination. CLINICALTRIALS.Gov identifierNCT03596879.
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Project description:ObjectiveCross-sectional research with adult samples suggests that hopelessness may indirectly affect suicidal ideation (SI) through overall depressive symptom severity. However, particular depressive symptom constellations, rather than overall symptoms, may underlie the association between hopelessness and SI. Yet, the cross-sectional nature of these studies precludes examination of the temporal associations among these constructs.MethodsUsing path analysis, the present study examined whether depression-related emotional problems mediate the relation between hopelessness and SI in a clinical sample of 110 adolescents over a 6-month period. The specificity of depression-related emotional problems as a mediator was also evaluated.ResultsAfter accounting for covariates, results supported the specificity of 3-month depression-related emotional problems as a mediator of the association between baseline levels of hopelessness and 6-month SI.ConclusionResults suggest that treatment targeted specifically at hopelessness may help reduce depression-related emotional problems and lower SI, and ultimately, adolescent suicide risk.
| S-EPMC8722668 | biostudies-literature
Project description:BackgroundRecent analyses have described metabolomic markers for depression and suicidal ideation in non-pregnant adults. We examined the metabolomic profile of antepartum depression and suicidal ideation during mid-pregnancy, a time of high susceptibility to mood disorders.MethodsWe collected fasting blood from 100 pregnant Peruvian women and profiled 307 plasma metabolites using liquid chromatography-mass spectrometry. We used the Patient Health Questionnaire 9 to define antepartum depression (score ≥ 10) and suicidal ideation (having thoughts that you would be better off dead, or of hurting yourself). Logistic regression was used to calculate odds ratios (ORs).ResultsThree triacylglycerol metabolites (C48:5 triacylglycerol [OR = =1.89; 95% confidence interval (CI): 1.14-3.14], C50:6 triacylglycerol [OR = =1.88; 95%CI: 1.13-3.14], C46:4 triacylglycerol [OR = =1.89; 95%CI: 1.11-3.21]) were associated with higher odds of antepartum depression and 4 metabolites (betaine [OR = =0.56; 95%CI:0.33-0.95], citrulline [OR = =0.58; 95%CI: 0.34-0.98], C5 carnitine [OR = =0.59; 95%CI: 0.36-0.99], C5:1 carnitine [OR = =0.59; 95%CI: 0.35-1.00]) with lower odds of antepartum depression. Twenty-six metabolites, including 5-hydroxytryptophan (OR = =0.52; 95%CI: 0.30-0.92), phenylalanine (OR = =0.41; 95%CI: 0.19-0.91), and betaine (OR = =0.53; 95%CI: 0.28-0.99) were associated with lower odds of suicidal ideation.LimitationsOur cross-sectional study could not determine whether metabolites prospectively predict outcomes. No metabolites remained significant after multiple testing correction; these novel findings should be replicated in a larger sample.ConclusionsAntepartum suicidal ideation metabolomic markers are similar to markers of depression among non-pregnant adults, and distinct from markers of antepartum depression. Findings suggest that mood disorder in pregnancy shares metabolomic similarities to mood disorder at other times and may further understanding of these conditions' pathophysiology.
| S-EPMC6917910 | biostudies-literature
Project description:BackgroundDefining the neurobiological underpinnings of suicidal ideation (SI) is crucial to improving our understanding of suicide. This study used magnetoencephalographic gamma power as a surrogate marker for population-level excitation-inhibition balance to explore the underlying neurobiology of SI and depression. In addition, effects of pharmacological intervention with ketamine, which has been shown to rapidly reduce SI and depression, were assessed.MethodsData were obtained from 29 drug-free patients with major depressive disorder who participated in an experiment comparing subanesthetic ketamine (0.5 mg/kg) with a placebo saline infusion. Magnetoencephalographic recordings were collected at baseline and after ketamine and placebo infusions. During scanning, patients rested with their eyes closed. SI and depression were assessed, and a linear mixed-effects model was used to identify brain regions where gamma power and both SI and depression were associated. Two regions of the salience network (anterior insula, anterior cingulate) were then probed using dynamic causal modeling to test for ketamine effects.ResultsClinically, patients showed significantly reduced SI and depression after ketamine administration. In addition, distinct regions in the anterior insula were found to be associated with SI compared with depression. In modeling of insula-anterior cingulate connectivity, ketamine lowered the membrane capacitance for superficial pyramidal cells. Finally, connectivity between the insula and anterior cingulate was associated with improvements in depression symptoms.ConclusionsThese findings suggest that the anterior insula plays a key role in SI, perhaps via its role in salience detection. In addition, transient changes in superficial pyramidal cell membrane capacitance and subsequent increases in cortical excitability might be a mechanism through which ketamine improves SI.
| S-EPMC7064429 | biostudies-literature
Project description:BACKGROUND:Suicide is a leading cause of death among youth. Prior research using transcranial magnetic stimulation (TMS) has implicated deficits in GABAergic cortical inhibition in adolescent suicidal behavior, yet no studies have assessed whether cortical inhibition varies over time in conjunction with changes in suicidal ideation (SI). This study examined dynamic changes in long-interval intracortical inhibition (LICI), a TMS measure of GABAB-mediated inhibition, and their relationship with changes in SI in a small sample of adolescents undergoing pharmacologic treatment for depression. METHODS:Ten depressed adolescents (aged 13-17) underwent clinical assessment and TMS testing at baseline and again at follow-up. All were treated with antidepressant medication in the interim. SI was measured with the Columbia Suicide Severity Rating Scale (C-SSRS) Intensity of Ideation subscale. LICI was measured at interstimulus intervals of 100 and 150?ms. RESULTS:There was a significant partial correlation, controlling for change in depression severity, between ?LICI-100 and change in SI as measured by ?C-SSRS (??=?.746, df?=?7, p?=?.021), which remained after also controlling for time to follow-up assessment (??=?.752, df?=?6, p?=?.032). No significant correlation was observed between ?LICI-150 and change in SI. LIMITATIONS:Sample size; variable follow-up interval; inability to control for age, sex, and potential treatment effects. CONCLUSIONS:These data offer preliminary signal of an association between increases in GABAB-mediated cortical inhibition and reduction in SI over time in adolescents treated for depression. Further studies are warranted to explore the role of cortical inhibition in adolescent suicidal ideation and behavior.
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