To the Editor: We thank Dr Andrade1 for his interest in our work.2 What he describes as an observational study was in fact an analysis of 12-month relapse from a randomized trial of unilateral vs bilateral electroconvulsive therapy (ECT) for depression, ie, a planned secondary outcome of an interventional study. The hypothesis underlying the trial was noninferiority of right unilateral versus bitemporal ECT.3 Randomization and blinding were preserved throughout the follow-up period. In this secondary analysis, we examined long-term outcomes because it could be argued that although acute outcomes were similar in the two groups, remission may be more transient in the unilateral group and the advantage of bitemporal ECT would only become apparent later. As such, electrode placement (ie, treatment group) was the main covariate of interest and cannot be dropped from the regression model simply because it turned out not to be “significant.” Dr Andrade seems to suggest that including a priori known prognostic factors in a regression model is overfitting. On the contrary, this is standard practice. Inclusion of these covariates reduces the amount of residual variance in the model. Choice of covariates is never an easy task, but it is particularly challenging in a situation like this one, in which thousands of clinical and biological datapoints were recorded. Knowing that we would ultimately be faced with a large number of candidate covariates and the danger of observing many (possibly spurious) associations, we limited ourselves to a handful of known prognostic factors found in systematic reviews of the ECT literature and/or large cohort studies of recurrence in treatment-resistant depression in order to avoid overfitting. There is over half a century of prospective research on post-ECT relapse. Several immutable patient and illness characteristics have been shown to predict both acute and long-term ECT outcomes, while ECT technical parameters or the adequacy of post-ECT prophylactic treatment do not moderate long-term outcomes to any clinically meaningful degree, with two known exceptions: lithium4 and continuation ECT.5 Maximizing the chances of a good long-term outcome, therefore, is largely predicated on careful patient selection, ensuring that ECT is delivered only to those who are suitable candidates for it. For these reasons, second-generation antipsychotics were not analyzed since there is, to our knowledge, no evidence demonstrating their usefulness in mitigating post-ECT relapse. Recent large observational studies from Scandinavia have shown that antipsychotics are associated with worse long-term outcomes after ECT in unipolar6 and bipolar depression.7 While causality cannot be inferred from these studies, the preliminary evidence is not encouraging. At any rate, the proportion of our remitters maintained on second-generation antipsychotics (mean dose of 8 mg olanzapine equivalents) who relapsed was similar to those treated with other medicatio
{"title":"Twelve-Month Outcomes for Remitters Following Electroconvulsive Therapy for Depression.","authors":"A. Jelovac, D. McLoughlin","doi":"10.4088/jcp.21lr14371","DOIUrl":"https://doi.org/10.4088/jcp.21lr14371","url":null,"abstract":"To the Editor: We thank Dr Andrade1 for his interest in our work.2 What he describes as an observational study was in fact an analysis of 12-month relapse from a randomized trial of unilateral vs bilateral electroconvulsive therapy (ECT) for depression, ie, a planned secondary outcome of an interventional study. The hypothesis underlying the trial was noninferiority of right unilateral versus bitemporal ECT.3 Randomization and blinding were preserved throughout the follow-up period. In this secondary analysis, we examined long-term outcomes because it could be argued that although acute outcomes were similar in the two groups, remission may be more transient in the unilateral group and the advantage of bitemporal ECT would only become apparent later. As such, electrode placement (ie, treatment group) was the main covariate of interest and cannot be dropped from the regression model simply because it turned out not to be “significant.” Dr Andrade seems to suggest that including a priori known prognostic factors in a regression model is overfitting. On the contrary, this is standard practice. Inclusion of these covariates reduces the amount of residual variance in the model. Choice of covariates is never an easy task, but it is particularly challenging in a situation like this one, in which thousands of clinical and biological datapoints were recorded. Knowing that we would ultimately be faced with a large number of candidate covariates and the danger of observing many (possibly spurious) associations, we limited ourselves to a handful of known prognostic factors found in systematic reviews of the ECT literature and/or large cohort studies of recurrence in treatment-resistant depression in order to avoid overfitting. There is over half a century of prospective research on post-ECT relapse. Several immutable patient and illness characteristics have been shown to predict both acute and long-term ECT outcomes, while ECT technical parameters or the adequacy of post-ECT prophylactic treatment do not moderate long-term outcomes to any clinically meaningful degree, with two known exceptions: lithium4 and continuation ECT.5 Maximizing the chances of a good long-term outcome, therefore, is largely predicated on careful patient selection, ensuring that ECT is delivered only to those who are suitable candidates for it. For these reasons, second-generation antipsychotics were not analyzed since there is, to our knowledge, no evidence demonstrating their usefulness in mitigating post-ECT relapse. Recent large observational studies from Scandinavia have shown that antipsychotics are associated with worse long-term outcomes after ECT in unipolar6 and bipolar depression.7 While causality cannot be inferred from these studies, the preliminary evidence is not encouraging. At any rate, the proportion of our remitters maintained on second-generation antipsychotics (mean dose of 8 mg olanzapine equivalents) who relapsed was similar to those treated with other medicatio","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88666276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: It is currently unclear if a course of electroconvulsive therapy (ECT) is associated with a decreased risk of death by suicide. The limited literature based on evidence either does not reflect contemporary practice or else includes patients receiving as few as one treatment. We sought to examine the association of an adequate exposure to ECT treatment with risk of death by suicide in a present-day sample. Methods: We conducted a study using electronic medical record data from the Department of Veterans Affairs health system from between 2000 and 2017. We compared all-cause and suicide mortality among patients who received an index course of ECT with a comparison group created through propensity score matching. Results: Our sample included 5,157 index courses of ECT. The suicide death rate in those receiving ECT was 137.34 deaths per 10,000 in 30 days and 804.39 per 10,000 in 365 days. The rate of death by suicide in the control group was 138.65 per 10,000 in 30 days and 564.52 per 10,000 in 1 year. The relative risk of death by suicide comparing those receiving an index course of ECT and the matched group was 0.96 (95% CI, 0.38-1.55; P = .994) in 30 days and 1.38 (95% CI, 0.88-1.87; P = .10) in 1 year. Conclusion: The risk of suicide mortality 30 days and 1 year following treatment was similar in patients treated with an index course ECT and in a matched group. There was no evidence that an ECT course decreased the risk of death by suicide.
{"title":"Electroconvulsive Therapy and Death by Suicide.","authors":"B. Watts, Talya Peltzman, B. Shiner","doi":"10.4088/jcp.21m13886","DOIUrl":"https://doi.org/10.4088/jcp.21m13886","url":null,"abstract":"Background: It is currently unclear if a course of electroconvulsive therapy (ECT) is associated with a decreased risk of death by suicide. The limited literature based on evidence either does not reflect contemporary practice or else includes patients receiving as few as one treatment. We sought to examine the association of an adequate exposure to ECT treatment with risk of death by suicide in a present-day sample.\u0000Methods: We conducted a study using electronic medical record data from the Department of Veterans Affairs health system from between 2000 and 2017. We compared all-cause and suicide mortality among patients who received an index course of ECT with a comparison group created through propensity score matching.\u0000Results: Our sample included 5,157 index courses of ECT. The suicide death rate in those receiving ECT was 137.34 deaths per 10,000 in 30 days and 804.39 per 10,000 in 365 days. The rate of death by suicide in the control group was 138.65 per 10,000 in 30 days and 564.52 per 10,000 in 1 year. The relative risk of death by suicide comparing those receiving an index course of ECT and the matched group was 0.96 (95% CI, 0.38-1.55; P = .994) in 30 days and 1.38 (95% CI, 0.88-1.87; P = .10) in 1 year.\u0000Conclusion: The risk of suicide mortality 30 days and 1 year following treatment was similar in patients treated with an index course ECT and in a matched group. There was no evidence that an ECT course decreased the risk of death by suicide.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75755375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elan A Cohen, T. Skubiak, Dusica Hadzi Boskovic, Keinya Norman, Jonathan Knights, H. Fang, Antonia K Coppin-Renz, T. Peters-Strickland, J. Lindenmayer, J. C. Reuteman-Fowler
Objective: Inpatient psychiatric admissions drive the financial burden of schizophrenia, and medication adherence remains challenging. We assessed whether aripiprazole tablets with sensor (AS; system includes ingestible event-marker sensor, wearable sensor patches, and smartphone application) could reduce psychiatric hospitalizations compared with oral standard-of-care (SOC) antipsychotics. Methods: This phase 3b, mirror-image clinical trial was conducted from April 29, 2019-August 11, 2020, in adults with schizophrenia with ≥ 1 hospitalization in the previous 48 months who had been prescribed oral SOC for the preceding 6 months (retrospective phase). All participants used AS for at least 3 months and up to 6 months. Primary endpoint was the inpatient psychiatric hospitalization rate in the modified intent-to-treat (mITT; n = 113) population during prospective months 1-3 versus retrospective phase. Proportion of days covered by medication was the secondary endpoint. Safety endpoints included adverse events related to the medication or patch and suicidality. Results: AS significantly reduced hospitalizations during prospective months 1-3 (-9.7%) and months 1-6 (-21.3% [P ≤ .001 for all comparisons]) in the mITT population versus the corresponding retrospective phase. AS use improved confirmed medication ingestion by 26.5 percentage points in prospective months 1-3 (P ≤ .001) and reduced PANSS scores. Patches were well-tolerated, and no participant reported changes in suicide risk. Conclusions: Compared with oral SOC, AS reduced inpatient psychiatric hospitalization rates for adults with mild-to-moderate schizophrenia. The AS system may aid medication ingestion and is associated with improvements in symptoms, potentially reducing acute-care needs among patients with schizophrenia. Trial Registration: ClinicalTrials.gov identifier: NCT03892889.
{"title":"Phase 3b Multicenter, Prospective, Open-label Trial to Evaluate the Effects of a Digital Medicine System on Inpatient Psychiatric Hospitalization Rates for Adults With Schizophrenia.","authors":"Elan A Cohen, T. Skubiak, Dusica Hadzi Boskovic, Keinya Norman, Jonathan Knights, H. Fang, Antonia K Coppin-Renz, T. Peters-Strickland, J. Lindenmayer, J. C. Reuteman-Fowler","doi":"10.4088/jcp.21m14132","DOIUrl":"https://doi.org/10.4088/jcp.21m14132","url":null,"abstract":"Objective: Inpatient psychiatric admissions drive the financial burden of schizophrenia, and medication adherence remains challenging. We assessed whether aripiprazole tablets with sensor (AS; system includes ingestible event-marker sensor, wearable sensor patches, and smartphone application) could reduce psychiatric hospitalizations compared with oral standard-of-care (SOC) antipsychotics.\u0000Methods: This phase 3b, mirror-image clinical trial was conducted from April 29, 2019-August 11, 2020, in adults with schizophrenia with ≥ 1 hospitalization in the previous 48 months who had been prescribed oral SOC for the preceding 6 months (retrospective phase). All participants used AS for at least 3 months and up to 6 months. Primary endpoint was the inpatient psychiatric hospitalization rate in the modified intent-to-treat (mITT; n = 113) population during prospective months 1-3 versus retrospective phase. Proportion of days covered by medication was the secondary endpoint. Safety endpoints included adverse events related to the medication or patch and suicidality.\u0000Results: AS significantly reduced hospitalizations during prospective months 1-3 (-9.7%) and months 1-6 (-21.3% [P ≤ .001 for all comparisons]) in the mITT population versus the corresponding retrospective phase. AS use improved confirmed medication ingestion by 26.5 percentage points in prospective months 1-3 (P ≤ .001) and reduced PANSS scores. Patches were well-tolerated, and no participant reported changes in suicide risk.\u0000Conclusions: Compared with oral SOC, AS reduced inpatient psychiatric hospitalization rates for adults with mild-to-moderate schizophrenia. The AS system may aid medication ingestion and is associated with improvements in symptoms, potentially reducing acute-care needs among patients with schizophrenia.\u0000Trial Registration: ClinicalTrials.gov identifier: NCT03892889.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77586782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S ir William Osler, the great Canadian physician who is considered one of the fathers of clinical medicine, once remarked that the desire to take medicine is perhaps the greatest feature which distinguishes man from animals.1 Maybe patients were different in his day, but, clearly, this is not my experience. Working in an urban community mental health center, one of my biggest challenges is to help patients with a serious mental illness (SMI) like schizophrenia or psychotic bipolar disorder stick with their antipsychotic maintenance treatment to avoid hospitalizations. Managing adherence is a critical clinical task for chronic disorders like schizophrenia or bipolar disorder as the cost of nonadherence and the resulting pattern of recurring acute illness episodes is potentially high. In addition to reduced medication efficacy over time due to biological changes from frequent relapse,2 each relapse can have devastating psychosocial consequences, in the form of loss of a job, derailed education, criminal problems, reputational damage, or suicide. Tragically, while antipsychotics are highly effective in preventing psychotic relapse in schizophrenia (number needed to treat [NNT] of 3),3 adherence is often poor, with almost half of patients taking less than 70% of prescribed doses.4 Simply prescribing oral medications with no clinical program and strategy to support adherence is therefore not enough for many patients with SMI, particularly when medications need to be taken for many years. One problem clinicians face is that the assessment of adherence is not straightforward, with no single strategy providing the complete picture. Much clinic time is spent guessing the degree of a patient’s adherence, often missing partial adherence.5 Self-report is notoriously poor, with patients confidently overestimating their adherence.6 Clinicians also fall prey to the better-than-average bias that is operative here, judging their own patients’ adherence to be better than comparable patients treated by other clinicians. Inevitably, technological solutions have emerged to help clinicians assess and monitor antipsychotic adherence more objectively. One early technology was the so-called Medication Event Monitoring System (MEMS) cap in research settings, which could monitor the opening of a pill bottle (but not the swallowing of a pill). The next generation of adherence monitoring tools is represented by more advanced digital medicine systems (DMS) that automatically track the actual taking of a pill. The basic principles of such systems are straightforward: a patient takes a pill that contains a sensor (also referred to as an Ingestible Event Marker [IEM]) that is activated by stomach acid, sending a signal to a wearable sensor patch that in turn sends the information to a mobile device app and, if desired, onto a cloud-based server. Adherence data can be viewed by patients or whomever else has been granted access. One of the first DMS approved by the FDA in 2017 was
{"title":"What Is the Role of Digital Medicine for Adherence Monitoring in Patients With Serious Mental Illness?","authors":"O. Freudenreich","doi":"10.4088/jcp.22com14443","DOIUrl":"https://doi.org/10.4088/jcp.22com14443","url":null,"abstract":"S ir William Osler, the great Canadian physician who is considered one of the fathers of clinical medicine, once remarked that the desire to take medicine is perhaps the greatest feature which distinguishes man from animals.1 Maybe patients were different in his day, but, clearly, this is not my experience. Working in an urban community mental health center, one of my biggest challenges is to help patients with a serious mental illness (SMI) like schizophrenia or psychotic bipolar disorder stick with their antipsychotic maintenance treatment to avoid hospitalizations. Managing adherence is a critical clinical task for chronic disorders like schizophrenia or bipolar disorder as the cost of nonadherence and the resulting pattern of recurring acute illness episodes is potentially high. In addition to reduced medication efficacy over time due to biological changes from frequent relapse,2 each relapse can have devastating psychosocial consequences, in the form of loss of a job, derailed education, criminal problems, reputational damage, or suicide. Tragically, while antipsychotics are highly effective in preventing psychotic relapse in schizophrenia (number needed to treat [NNT] of 3),3 adherence is often poor, with almost half of patients taking less than 70% of prescribed doses.4 Simply prescribing oral medications with no clinical program and strategy to support adherence is therefore not enough for many patients with SMI, particularly when medications need to be taken for many years. One problem clinicians face is that the assessment of adherence is not straightforward, with no single strategy providing the complete picture. Much clinic time is spent guessing the degree of a patient’s adherence, often missing partial adherence.5 Self-report is notoriously poor, with patients confidently overestimating their adherence.6 Clinicians also fall prey to the better-than-average bias that is operative here, judging their own patients’ adherence to be better than comparable patients treated by other clinicians. Inevitably, technological solutions have emerged to help clinicians assess and monitor antipsychotic adherence more objectively. One early technology was the so-called Medication Event Monitoring System (MEMS) cap in research settings, which could monitor the opening of a pill bottle (but not the swallowing of a pill). The next generation of adherence monitoring tools is represented by more advanced digital medicine systems (DMS) that automatically track the actual taking of a pill. The basic principles of such systems are straightforward: a patient takes a pill that contains a sensor (also referred to as an Ingestible Event Marker [IEM]) that is activated by stomach acid, sending a signal to a wearable sensor patch that in turn sends the information to a mobile device app and, if desired, onto a cloud-based server. Adherence data can be viewed by patients or whomever else has been granted access. One of the first DMS approved by the FDA in 2017 was","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82133798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ismael Martínez-Nicolás, Pavel E. Arenas Castañeda, Cristian Antonio Molina-Pizarro, Arsenio Rosado Franco, Cynthya Maya-Hernández, Igor Barahona, G. Martínez-Alés, Fuensanta Aroca Bisquert, E. Baca-García, M. Barrigón
Background: Depression, anxiety, well-being, and suicidality are highly associated during adolescence and greatly predict mental health outcomes during adulthood. This study explored relationships between these variables among students from Mexico City. Methods: This representative cross-sectional study was carried out in education centers in Mexico City during the 2019-2020 academic year. Using a smartphone app, we implemented validated questionnaires for depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), well-being (World Health Organization 5 Well-Being Index), and risk of suicide (Columbia-Suicide Severity Rating Scale). Partial least squares structural equation modeling was performed for the entire sample and after stratifying by gender. Results: Out of 3,042 students, 1,686 were females; mean age of the sample was 17.3 years. Compared to males, females had higher levels of anxiety, depressive symptoms, and suicidal ideation and lower levels of self-perceived well-being. Structural equation models indicated that depression was the main predictor of the rest of the outcomes in the overall sample. The role of anxiety was heterogeneous across genders and not clearly correlated to suicidal behavior or well-being. Conclusions: Large-scale mental health screening using an online tool proved feasible, with high response rates. Depression was the most important factor influencing anxiety, suicidal behavior, and well-being in Mexican high school students. The roles of depression and anxiety were heterogeneous across genders. Trial Registration: ClinicalTrials.gov Identifier: NCT04067076.
{"title":"Impact of Depression on Anxiety, Well-being, and Suicidality in Mexican Adolescent and Young Adult Students From Mexico City: A Mental Health Screening Using Smartphones.","authors":"Ismael Martínez-Nicolás, Pavel E. Arenas Castañeda, Cristian Antonio Molina-Pizarro, Arsenio Rosado Franco, Cynthya Maya-Hernández, Igor Barahona, G. Martínez-Alés, Fuensanta Aroca Bisquert, E. Baca-García, M. Barrigón","doi":"10.4088/jcp.20m13806","DOIUrl":"https://doi.org/10.4088/jcp.20m13806","url":null,"abstract":"Background: Depression, anxiety, well-being, and suicidality are highly associated during adolescence and greatly predict mental health outcomes during adulthood. This study explored relationships between these variables among students from Mexico City.\u0000Methods: This representative cross-sectional study was carried out in education centers in Mexico City during the 2019-2020 academic year. Using a smartphone app, we implemented validated questionnaires for depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), well-being (World Health Organization 5 Well-Being Index), and risk of suicide (Columbia-Suicide Severity Rating Scale). Partial least squares structural equation modeling was performed for the entire sample and after stratifying by gender.\u0000Results: Out of 3,042 students, 1,686 were females; mean age of the sample was 17.3 years. Compared to males, females had higher levels of anxiety, depressive symptoms, and suicidal ideation and lower levels of self-perceived well-being. Structural equation models indicated that depression was the main predictor of the rest of the outcomes in the overall sample. The role of anxiety was heterogeneous across genders and not clearly correlated to suicidal behavior or well-being.\u0000Conclusions: Large-scale mental health screening using an online tool proved feasible, with high response rates. Depression was the most important factor influencing anxiety, suicidal behavior, and well-being in Mexican high school students. The roles of depression and anxiety were heterogeneous across genders.\u0000Trial Registration: ClinicalTrials.gov Identifier: NCT04067076.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85140118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Selective serotonin reuptake inhibitors (SSRIs) may predispose to postpartum hemorrhage (PPH) by interfering with platelet-mediated hemostasis and serotonin-mediated myometrial contractility. A meta-analysis of 8 observational studies found that, regardless of drug class, gestational exposure to antidepressants was associated with a small (odds ratio, 1.25) but statistically significantly increased risk of PPH; however, this finding was true only when antidepressant exposure was proximal to the date of delivery. A recent, moderately large, nationally representative, Swedish observational study also found that gestational exposure to SSRIs was associated with a significantly increased risk of PPH; the crude number needed to harm was 48. For reasons related to the methodology employed, it is possible that the risk was underestimated in this study. The findings of the meta-analysis and of the observational study are examined with a view to help readers understand how to critically read and interpret the research literature in the field. A reasonable viewpoint is that the increase in risk of PPH associated with gestational exposure to SSRIs is smaller than the increase in risk associated with obstetric risk factors for PPH; nevertheless, following precautionary measures would be wise. Such measures would include the routine administration of a uterotonic agent immediately after delivery to all women who have received serotonin reuptake inhibitor treatment during the month preceding delivery; the choice of uterotonic agent would depend on local hospital protocols. Women at risk should also be closely monitored for continued blood loss during the first 24 hours after delivery.
{"title":"Selective Serotonin Reuptake Inhibitor Use in Pregnancy and Risk of Postpartum Hemorrhage.","authors":"C. Andrade","doi":"10.4088/jcp.22f14455","DOIUrl":"https://doi.org/10.4088/jcp.22f14455","url":null,"abstract":"Selective serotonin reuptake inhibitors (SSRIs) may predispose to postpartum hemorrhage (PPH) by interfering with platelet-mediated hemostasis and serotonin-mediated myometrial contractility. A meta-analysis of 8 observational studies found that, regardless of drug class, gestational exposure to antidepressants was associated with a small (odds ratio, 1.25) but statistically significantly increased risk of PPH; however, this finding was true only when antidepressant exposure was proximal to the date of delivery. A recent, moderately large, nationally representative, Swedish observational study also found that gestational exposure to SSRIs was associated with a significantly increased risk of PPH; the crude number needed to harm was 48. For reasons related to the methodology employed, it is possible that the risk was underestimated in this study. The findings of the meta-analysis and of the observational study are examined with a view to help readers understand how to critically read and interpret the research literature in the field. A reasonable viewpoint is that the increase in risk of PPH associated with gestational exposure to SSRIs is smaller than the increase in risk associated with obstetric risk factors for PPH; nevertheless, following precautionary measures would be wise. Such measures would include the routine administration of a uterotonic agent immediately after delivery to all women who have received serotonin reuptake inhibitor treatment during the month preceding delivery; the choice of uterotonic agent would depend on local hospital protocols. Women at risk should also be closely monitored for continued blood loss during the first 24 hours after delivery.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81969666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
D. Pilon, C. Neslusan, M. Zhdanava, J. Sheehan, K. Joshi, L. Morrison, C. Rossi, P. Lefebvre, P. Greenberg
Objective: Suicidal ideation or behavior (SIB) is a symptom of major depressive disorder (MDD). This study evaluated health care resource utilization (HRU) and costs of commercially insured adults who had diagnosed MDD with acute SIB (MDSI). Methods: Adults with MDSI (index date: first SIB claim) and controls without MDD or suicide-related claims (random index date) were identified using International Classification of Diseases, Clinical Modification, 10th Revision codes in the OptumHealth Care Solutions, Inc. database (October 2014 to March 2017). Adults with < 12 months of plan enrollment pre-index and/or selected psychiatric comorbidities were excluded. MDSI and control cohorts were matched 1:1 on demographics and comorbidities. HRU and costs were compared between matched cohorts during up to 1 and 12 months post-index (inclusive) using regressions adjusted for baseline costs. Results: Among patients with MDSI (n = 1,576, mean age = 34 years, 55.6% female), most index events occurred in emergency department (ED; 50.7%) and inpatient (45.2%) settings. The MDSI cohort, compared with the control cohort within 1 and 12 months post-index, respectively, had 157.7 and 28.0 times more inpatient admissions, 16.4 and 5.4 times more ED visits, and 4.9 and 3.2 times more outpatient visits (all P < .01). Incremental health care costs per patient per month in the MDSI compared with the control cohort within 1 and 12 months were $7,839 and $2,757, respectively (both P values < .01). Inpatient and ED costs constituted 70.6% and 16.5% of the total incremental costs, respectively, within the first month of follow-up. Conclusions: Among commercially insured adults, MDSI was associated with significant economic burden; inpatient and ED services drove incremental costs of the condition. Further assessment of treatment options for this vulnerable patient population is warranted.
目的:自杀意念或行为(SIB)是重度抑郁症(MDD)的一种症状。本研究评估商业保险成人诊断为重度抑郁症合并急性SIB (MDSI)的卫生保健资源利用(HRU)和成本。方法:使用OptumHealth Care Solutions, Inc.数据库(2014年10月至2017年3月)中的国际疾病分类、临床修改、第10次修订代码，对患有MDSI的成年人(索引日期:第一次SIB索赔)和没有MDD或自杀相关索赔的对照组(随机索引日期)进行鉴定。排除计划入组前指数和/或选定精神疾病合并症< 12个月的成人。MDSI组和对照组在人口统计学和合并症方面按1:1匹配。使用基线成本调整后的回归，比较匹配队列在指数后1个月和12个月(包括)的HRU和成本。结果:在MDSI患者中(1576例，平均年龄34岁，女性55.6%)，大多数指标事件发生在急诊科(ED;50.7%)和住院(45.2%)。与对照组相比，MDSI组在指数后1个月和12个月内的住院次数分别增加了157.7和28.0倍，急诊次数分别增加了16.4和5.4倍，门诊次数分别增加了4.9和3.2倍(均P < 0.01)。与对照组相比，MDSI组1个月和12个月内每位患者每月的增量医疗费用分别为7,839美元和2,757美元(P值均< 0.01)。住院费用和急诊科费用分别占随访第一个月内总增量费用的70.6%和16.5%。结论:在商业保险成年人中，MDSI与显著的经济负担相关;住院和急诊科服务增加了这种疾病的成本。有必要对这一弱势患者群体的治疗方案进行进一步评估。
{"title":"Economic Burden of Commercially Insured Patients With Major Depressive Disorder and Acute Suicidal Ideation or Behavior in the United States.","authors":"D. Pilon, C. Neslusan, M. Zhdanava, J. Sheehan, K. Joshi, L. Morrison, C. Rossi, P. Lefebvre, P. Greenberg","doi":"10.4088/jcp.21m14090","DOIUrl":"https://doi.org/10.4088/jcp.21m14090","url":null,"abstract":"Objective: Suicidal ideation or behavior (SIB) is a symptom of major depressive disorder (MDD). This study evaluated health care resource utilization (HRU) and costs of commercially insured adults who had diagnosed MDD with acute SIB (MDSI).\u0000Methods: Adults with MDSI (index date: first SIB claim) and controls without MDD or suicide-related claims (random index date) were identified using International Classification of Diseases, Clinical Modification, 10th Revision codes in the OptumHealth Care Solutions, Inc. database (October 2014 to March 2017). Adults with < 12 months of plan enrollment pre-index and/or selected psychiatric comorbidities were excluded. MDSI and control cohorts were matched 1:1 on demographics and comorbidities. HRU and costs were compared between matched cohorts during up to 1 and 12 months post-index (inclusive) using regressions adjusted for baseline costs.\u0000Results: Among patients with MDSI (n = 1,576, mean age = 34 years, 55.6% female), most index events occurred in emergency department (ED; 50.7%) and inpatient (45.2%) settings. The MDSI cohort, compared with the control cohort within 1 and 12 months post-index, respectively, had 157.7 and 28.0 times more inpatient admissions, 16.4 and 5.4 times more ED visits, and 4.9 and 3.2 times more outpatient visits (all P < .01). Incremental health care costs per patient per month in the MDSI compared with the control cohort within 1 and 12 months were $7,839 and $2,757, respectively (both P values < .01). Inpatient and ED costs constituted 70.6% and 16.5% of the total incremental costs, respectively, within the first month of follow-up.\u0000Conclusions: Among commercially insured adults, MDSI was associated with significant economic burden; inpatient and ED services drove incremental costs of the condition. Further assessment of treatment options for this vulnerable patient population is warranted.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89911543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ryo Sawagashira, R. Yamamura, R. Okubo, N. Hashimoto, Shuhei Ishikawa, Yoichi Ito, Norihiro Sato, I. Kusumi
Objective: The risk of diabetes development has been reported to differ among second-generation antipsychotics (SGAs). However, few studies have focused on the subthreshold change in glycated hemoglobin (HbA1c). Therefore, this study examined the subthreshold change in HbA1c and change in body mass index (BMI) 3 months after patients initiated one of 6 SGAs widely prescribed in Japan. Methods: This is a prospective cohort study of patients followed up based on the Japanese blood glucose monitoring guidelines for patients with schizophrenia. We collected eligible patients' demographic data, medication history, blood tests, and weight measurements both at baseline and 3 months after recruitment, between April 2013 and March 2015. In the 378 patients with schizophrenia, schizoaffective disorder, and bipolar disorder based on ICD-10, we compared the subthreshold change in HbA1c and the change in BMI 3 months after antipsychotic initiation by using multivariate regression analysis. Results: The subthreshold change in HbA1c 3 months after initiating blonanserin was significantly lower compared with olanzapine (B = -0.17, 95% CI = -0.31 to -0.04). In addition, the change in BMI 3 months after initiating blonanserin and aripiprazole was significantly lower compared with olanzapine (B = -0.93, 95% CI = -1.74 to -0.12; B = -0.71, 95% CI = -1.30 to -0.12, respectively). Conclusions: This is the first study to clarify the differences in the subthreshold change in HbA1c among SGAs. Our results suggest that blonanserin is likely to be a favorable treatment for patients with high risk of diabetes. Trial Registration: UMIN Clinical Trial Registry identifier: UMIN000009868.
目的:据报道，第二代抗精神病药物(SGAs)发生糖尿病的风险存在差异。然而，很少有研究关注糖化血红蛋白(HbA1c)的阈下变化。因此，本研究检测了在日本广泛开处方的6种SGAs中，患者服用其中一种后3个月HbA1c的阈下变化和体重指数(BMI)的变化。方法:这是一项基于日本精神分裂症患者血糖监测指南的前瞻性队列研究。在2013年4月至2015年3月期间，我们收集了符合条件的患者在基线和招募后3个月的人口统计数据、用药史、血液检查和体重测量数据。在基于ICD-10的378例精神分裂症、分裂情感性障碍和双相情感障碍患者中，我们采用多变量回归分析比较了抗精神病药物开始3个月后HbA1c的阈下变化和BMI的变化。结果:与奥氮平相比，布兰色林治疗3个月后HbA1c阈下变化显著降低(B = -0.17, 95% CI = -0.31 ~ -0.04)。此外，与奥氮平相比，布兰色林和阿立哌唑开始治疗3个月后BMI的变化显著降低(B = -0.93, 95% CI = -1.74 ~ -0.12;B = -0.71, 95% CI = -1.30至-0.12,分别)。结论:这是第一个阐明SGAs患者HbA1c阈下变化差异的研究。我们的研究结果表明，blonanserin可能是一种治疗糖尿病高危患者的有利药物。临床试验注册号:UMIN临床试验注册号:UMIN000009868。
{"title":"Subthreshold Change in Glycated Hemoglobin and Body Mass Index After the Initiation of Second-Generation Antipsychotics Among Patients With Schizophrenia or Bipolar Disorder: A Nationwide Prospective Cohort Study in Japan.","authors":"Ryo Sawagashira, R. Yamamura, R. Okubo, N. Hashimoto, Shuhei Ishikawa, Yoichi Ito, Norihiro Sato, I. Kusumi","doi":"10.4088/jcp.21m14099","DOIUrl":"https://doi.org/10.4088/jcp.21m14099","url":null,"abstract":"Objective: The risk of diabetes development has been reported to differ among second-generation antipsychotics (SGAs). However, few studies have focused on the subthreshold change in glycated hemoglobin (HbA1c). Therefore, this study examined the subthreshold change in HbA1c and change in body mass index (BMI) 3 months after patients initiated one of 6 SGAs widely prescribed in Japan.\u0000Methods: This is a prospective cohort study of patients followed up based on the Japanese blood glucose monitoring guidelines for patients with schizophrenia. We collected eligible patients' demographic data, medication history, blood tests, and weight measurements both at baseline and 3 months after recruitment, between April 2013 and March 2015. In the 378 patients with schizophrenia, schizoaffective disorder, and bipolar disorder based on ICD-10, we compared the subthreshold change in HbA1c and the change in BMI 3 months after antipsychotic initiation by using multivariate regression analysis.\u0000Results: The subthreshold change in HbA1c 3 months after initiating blonanserin was significantly lower compared with olanzapine (B = -0.17, 95% CI = -0.31 to -0.04). In addition, the change in BMI 3 months after initiating blonanserin and aripiprazole was significantly lower compared with olanzapine (B = -0.93, 95% CI = -1.74 to -0.12; B = -0.71, 95% CI = -1.30 to -0.12, respectively).\u0000Conclusions: This is the first study to clarify the differences in the subthreshold change in HbA1c among SGAs. Our results suggest that blonanserin is likely to be a favorable treatment for patients with high risk of diabetes.\u0000Trial Registration: UMIN Clinical Trial Registry identifier: UMIN000009868.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88435053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Martin J Lan, S. Pantazatos, R. Ogden, Harry Rubin-Falcone, D. Hellerstein, Patrick J. McGrath, J. Mann
Objective: Suicidal ideation (SI) is a risk factor for completed suicide. Our previous resting state functional magnetic resonance imaging (fMRI) study found that higher amplitude of low frequency fluctuation (ALFF) in right hippocampus and thalamus was associated with SI in major depressive disorder (MDD). The present study aimed to evaluate that association in participants with bipolar disorder (BD). Methods: Thirty depressed, adult participants with a DSM-IV diagnosis of BD had resting state fMRI scans. Region-of-interest (ROI) analyses used ALFF values within areas that were previously associated with SI in MDD. Spearman rank correlation and ordinal regression analyses were performed to assess associations between ALFF values and the SI item of the Montgomery-Asberg Depression Rating Scale. Exploratory whole-brain analyses identified regions where ALFF was associated with SI. Results: Within the right hippocampus region, SI was positively associated with ALFF (Spearman R = 0.490, P = .0060). Ordinal regression analysis indicated that for every 0.1-unit increase in ALFF in that region, the odds of having higher SI were increased by 35% (odds ratio = 1.35; 95% confidence interval, 1.08-1.73; P = .012). Within the previously identified thalamus cluster, SI was associated with ALFF only at a trend level (Spearman R = 0.310, P = .069). Whole-brain analyses identified 3 clusters of positive association between SI and ALFF, 1 of which was located in the right hippocampus. Conclusions: This study found that our previous finding of positive association between SI and ALFF in the right hippocampus extended to bipolar depression. Future studies should examine the clinical utility of this association, and the role of the hippocampus in SI. Trial Registration: Data used for this secondary analysis came from studies with ClinicalTrials.gov identifiers NCT02239094 (January 2015 through September 2016) and NCT02473250 (January 2015 through December 2019).
目的:自杀意念(SI)是自杀未遂的危险因素。我们之前的静息状态功能磁共振成像(fMRI)研究发现，重度抑郁症(MDD)患者右侧海马和丘脑低频波动(ALFF)振幅较高与SI相关。本研究旨在评估双相情感障碍(BD)参与者的这种关联。方法:30名被诊断为双相障碍的成年抑郁症患者进行静息状态功能磁共振成像扫描。兴趣区域(ROI)分析使用先前与MDD中的SI相关的区域内的ALFF值。采用Spearman秩相关分析和有序回归分析评估ALFF值与Montgomery-Asberg抑郁评定量表SI项的相关性。探索性全脑分析确定了ALFF与SI相关的区域。结果:在右侧海马区，SI与ALFF呈正相关(Spearman R = 0.490, P = 0.0060)。有序回归分析表明，该地区ALFF每增加0.1个单位，SI较高的几率增加35%(优势比= 1.35;95%置信区间为1.08-1.73;p = .012)。在先前确定的丘脑簇中，SI与ALFF仅在趋势水平上相关(Spearman R = 0.310, P = 0.069)。全脑分析发现，SI和ALFF之间存在3个正相关簇，其中1个位于右侧海马。结论:本研究发现，我们之前发现的右海马SI和ALFF之间的正相关关系延伸到双相抑郁症。未来的研究应该检查这种关联的临床应用，以及海马体在SI中的作用。试验注册:该次要分析使用的数据来自ClinicalTrials.gov标识符NCT02239094(2015年1月至2016年9月)和NCT02473250(2015年1月至2019年12月)的研究。
{"title":"Resting State MRI Amplitude of Low Frequency Fluctuations Associated With Suicidal Ideation in Bipolar Depression.","authors":"Martin J Lan, S. Pantazatos, R. Ogden, Harry Rubin-Falcone, D. Hellerstein, Patrick J. McGrath, J. Mann","doi":"10.4088/jcp.21m14054","DOIUrl":"https://doi.org/10.4088/jcp.21m14054","url":null,"abstract":"Objective: Suicidal ideation (SI) is a risk factor for completed suicide. Our previous resting state functional magnetic resonance imaging (fMRI) study found that higher amplitude of low frequency fluctuation (ALFF) in right hippocampus and thalamus was associated with SI in major depressive disorder (MDD). The present study aimed to evaluate that association in participants with bipolar disorder (BD).\u0000Methods: Thirty depressed, adult participants with a DSM-IV diagnosis of BD had resting state fMRI scans. Region-of-interest (ROI) analyses used ALFF values within areas that were previously associated with SI in MDD. Spearman rank correlation and ordinal regression analyses were performed to assess associations between ALFF values and the SI item of the Montgomery-Asberg Depression Rating Scale. Exploratory whole-brain analyses identified regions where ALFF was associated with SI.\u0000Results: Within the right hippocampus region, SI was positively associated with ALFF (Spearman R = 0.490, P = .0060). Ordinal regression analysis indicated that for every 0.1-unit increase in ALFF in that region, the odds of having higher SI were increased by 35% (odds ratio = 1.35; 95% confidence interval, 1.08-1.73; P = .012). Within the previously identified thalamus cluster, SI was associated with ALFF only at a trend level (Spearman R = 0.310, P = .069). Whole-brain analyses identified 3 clusters of positive association between SI and ALFF, 1 of which was located in the right hippocampus.\u0000Conclusions: This study found that our previous finding of positive association between SI and ALFF in the right hippocampus extended to bipolar depression. Future studies should examine the clinical utility of this association, and the role of the hippocampus in SI.\u0000Trial Registration: Data used for this secondary analysis came from studies with ClinicalTrials.gov identifiers NCT02239094 (January 2015 through September 2016) and NCT02473250 (January 2015 through December 2019).","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76338355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Five randomized controlled trials (RCTs) have compared racemic ketamine, mostly administered intravenously in the dose of 0.5 mg/kg across 40-45 minutes, with right unilateral or bilateral electroconvulsive therapy (ECT). These RCTs were conducted in samples of severely ill patients with mostly unipolar depression (with or without psychotic features) who were referred for ECT. Of these, 2 RCTs were of reasonably adequate quality to inform clinical practice; one, in fact, was large (n = 186) and had a 1-year post-treatment follow-up. In these RCTs, ECT emerged as a clearly superior treatment with regard to response rate, remission rate, time to response, time to remission, and magnitude of improvement at treatment endpoint; however, relapse rate and time to relapse did not differ between ECT and ketamine groups. ECT appeared superior in older patients and in those with psychotic depression, as well. These findings notwithstanding, response and remission rates with ketamine appeared sufficiently impressive for ketamine to be viewed as a viable alternative to ECT in severely depressed patients who are referred for ECT. Notably, in such patients ketamine does not appear to have dramatic antidepressant action; rather, the benefits evolve across a course of 6 or more alternate day, thrice weekly sessions, validating the concept of a course of ketamine treatment that is administered much as ECT is. Finally, whereas the high relapse rates after successful remission encourage the use of ECT and ketamine as continuation therapy, continuation ketamine must be carefully supervised in patients who are prone to substance abuse.
{"title":"Insights for the Use of Ketamine From Randomized Controlled Trials That Compared Ketamine With Electroconvulsive Therapy in Severe Depression.","authors":"C. Andrade","doi":"10.4088/jcp.22f14451","DOIUrl":"https://doi.org/10.4088/jcp.22f14451","url":null,"abstract":"Five randomized controlled trials (RCTs) have compared racemic ketamine, mostly administered intravenously in the dose of 0.5 mg/kg across 40-45 minutes, with right unilateral or bilateral electroconvulsive therapy (ECT). These RCTs were conducted in samples of severely ill patients with mostly unipolar depression (with or without psychotic features) who were referred for ECT. Of these, 2 RCTs were of reasonably adequate quality to inform clinical practice; one, in fact, was large (n = 186) and had a 1-year post-treatment follow-up. In these RCTs, ECT emerged as a clearly superior treatment with regard to response rate, remission rate, time to response, time to remission, and magnitude of improvement at treatment endpoint; however, relapse rate and time to relapse did not differ between ECT and ketamine groups. ECT appeared superior in older patients and in those with psychotic depression, as well. These findings notwithstanding, response and remission rates with ketamine appeared sufficiently impressive for ketamine to be viewed as a viable alternative to ECT in severely depressed patients who are referred for ECT. Notably, in such patients ketamine does not appear to have dramatic antidepressant action; rather, the benefits evolve across a course of 6 or more alternate day, thrice weekly sessions, validating the concept of a course of ketamine treatment that is administered much as ECT is. Finally, whereas the high relapse rates after successful remission encourage the use of ECT and ketamine as continuation therapy, continuation ketamine must be carefully supervised in patients who are prone to substance abuse.","PeriodicalId":20409,"journal":{"name":"Primary care companion to the Journal of clinical psychiatry","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77099928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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