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BMC Psychiatry May 2024The primary objective of this randomized controlled trial (RCT) is to establish the effectiveness of time-restricted eating (TRE) compared with the Mediterranean diet... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
BACKGROUND
The primary objective of this randomized controlled trial (RCT) is to establish the effectiveness of time-restricted eating (TRE) compared with the Mediterranean diet for people with bipolar disorder (BD) who have symptoms of sleep disorders or circadian rhythm sleep-wake disruption. This work builds on the growing evidence that TRE has benefits for improving circadian rhythms. TRE and Mediterranean diet guidance will be offered remotely using self-help materials and an app, with coaching support.
METHODS
This study is an international RCT to compare the effectiveness of TRE and the Mediterranean diet. Three hundred participants will be recruited primarily via social media. Main inclusion criteria are: receiving treatment for a diagnosis of BD I or II (confirmed via DIAMOND structured diagnostic interview), endorsement of sleep or circadian problems, self-reported eating window of ≥ 12 h, and no current mood episode, acute suicidality, eating disorder, psychosis, alcohol or substance use disorder, or other health conditions that would interfere with or limit the safety of following the dietary guidance. Participants will be asked to complete baseline daily food logging for two weeks and then will be randomly allocated to follow TRE or the Mediterranean diet for 8 weeks, during which time, they will continue to complete daily food logging. Intervention content will be delivered via an app. Symptom severity interviews will be conducted at baseline; mid-intervention (4 weeks after the intervention begins); end of intervention; and at 6, 9, and 15 months post-baseline by phone or videoconference. Self-rated symptom severity and quality of life data will be gathered at those timepoints, as well as at 16 weeks post baseline. To provide a more refined index of whether TRE successfully decreases emotional lability and improves sleep, participants will be asked to complete a sleep diary (core CSD) each morning and complete six mood assessments per day for eight days at baseline and again at mid-intervention.
DISCUSSION
The planned research will provide novel and important information on whether TRE is more beneficial than the Mediterranean diet for reducing mood symptoms and improving quality of life in individuals with BD who also experience sleep or circadian problems.
TRIAL REGISTRATION
ClinicalTrials.gov ID NCT06188754.
Topics: Humans; Bipolar Disorder; Diet, Mediterranean; Quality of Life; Sleep Wake Disorders; Adult; Female; Male; Circadian Rhythm
PubMed: 38762486
DOI: 10.1186/s12888-024-05790-4 -
Prague Medical Report 2024Second-generation antipsychotics (SGAs), also known as atypical antipsychotics, are a newer class of antipsychotic drugs used to treat schizophrenia, bipolar disorder,... (Review)
Review
Second-generation antipsychotics (SGAs), also known as atypical antipsychotics, are a newer class of antipsychotic drugs used to treat schizophrenia, bipolar disorder, and related psychiatric conditions. The plasma concentration of antipsychotic drugs is a valid measure of the drug at its primary target structure in the brain, and therefore determines the efficacy and safety of these drugs. However, despite the well-known high variability in pharmacokinetics of these substances, psychiatric medication is usually administered in uniform dosage schedules. Therapeutic drug monitoring (TDM), as the specific method that can help personalised medicine in dose adjustment according to the characteristics of the individual patient, minimizing the risk of toxicity, monitoring adherence, and increasing cost-effectiveness in the treatment, thus seems to be an elegant tool to solve this problem. Non-response to therapeutic doses, uncertain adherence to medication, suboptimal tolerability, or pharmacokinetic drug-drug interactions are typical indications for TDM of SGAs. This review aims to summarize an overview of the current knowledge and evidence of the possibilities to tailor the dosage of selected SGAs using TDM, including the necessary pharmacokinetic parameters for personalised pharmacotherapy.
Topics: Humans; Drug Monitoring; Antipsychotic Agents; Schizophrenia
PubMed: 38761044
DOI: 10.14712/23362936.2024.10 -
Journal of Psychiatric Research May 2024Deep transcranial magnetic stimulation (dTMS) has gained attention as an enhanced form of traditional TMS, targeting broader and deeper regions of the brain. However, a... (Review)
Review
Deep transcranial magnetic stimulation (dTMS) has gained attention as an enhanced form of traditional TMS, targeting broader and deeper regions of the brain. However, a fulsome synthesis of dTMS efficacy across psychiatric and cognitive disorders using sham-controlled trials is lacking. We systematically reviewed 28 clinical trials comparing active dTMS to a sham/controlled condition to characterize dTMS efficacy across diverse psychiatric and cognitive disorders. A comprehensive search of APA PsycINFO, Cochrane, Embase, Medline, and PubMed databases was conducted. Predominant evidence supports dTMS efficacy in patients with obsessive-compulsive disorder (OCD; n = 2), substance use disorders (SUDs; n = 8), and in those experiencing depressive episodes with major depressive disorder (MDD) or bipolar disorder (BD; n = 6). However, the clinical efficacy of dTMS in psychiatric disorders characterized by hyperactivity or hyperarousal (i.e., attention-deficit/hyperactivity disorder, posttraumatic stress disorder, and schizophrenia) was heterogeneous. Common side effects included headaches and pain/discomfort, with rare but serious adverse events such as seizures and suicidal ideation/attempts. Risk of bias ratings indicated a collectively low risk according to the Grading of Recommendations, Assessment, Development, and Evaluations checklist (Meader et al., 2014). Literature suggests promise for dTMS as a beneficial alternative or add-on treatment for patients who do not respond well to traditional treatment, particularly for depressive episodes, OCD, and SUDs. Mixed evidence and limited clinical trials for other psychiatric and cognitive disorders suggest more extensive research is warranted. Future research should examine the durability of dTMS interventions and identify moderators of clinical efficacy.
PubMed: 38759496
DOI: 10.1016/j.jpsychires.2024.05.011 -
International Journal of Bipolar... May 2024Bipolar disorder (BD) is a severe psychiatric disorder characterized by changes in mood that alternate between (hypo) mania or depression and mixed states, often...
BACKGROUND
Bipolar disorder (BD) is a severe psychiatric disorder characterized by changes in mood that alternate between (hypo) mania or depression and mixed states, often associated with functional impairment and cognitive dysfunction. But little is known about biomarkers that contribute to the development and sustainment of cognitive deficits. The aim of this study was to review the association between neurocognition and biomarkers across different mood states.
METHOD
Search databases were Web of Science, Scopus and PubMed. A systematic review was carried out following the PRISMA guidelines. Risk of bias was assessed with the Newcastle-Ottawa Scale. Studies were selected that focused on the correlation between neuroimaging, physiological, genetic or peripheral biomarkers and cognition in at least two phases of BD: depression, (hypo)mania, euthymia or mixed. PROSPERO Registration No.: CRD42023410782.
RESULTS
A total of 1824 references were screened, identifying 1023 published articles, of which 336 were considered eligible. Only 16 provided information on the association between biomarkers and cognition in the different affective states of BD. The included studies found: (i) Differences in levels of total cholesterol and C reactive protein depending on mood state; (ii) There is no association found between cognition and peripheral biomarkers; (iii) Neuroimaging biomarkers highlighted hypoactivation of frontal areas as distinctive of acute state of BD; (iv) A deactivation failure has been reported in the ventromedial prefrontal cortex (vmPFC), potentially serving as a trait marker of BD.
CONCLUSION
Only a few recent articles have investigated biomarker-cognition associations in BD mood phases. Our findings underline that there appear to be central regions involved in BD that are observed in all mood states. However, there appear to be underlying mechanisms of cognitive dysfunction that may vary across different mood states in BD. This review highlights the importance of standardizing the data and the assessment of cognition, as well as the need for biomarkers to help prevent acute symptomatic phases of the disease, and the associated functional and cognitive impairment.
PubMed: 38758506
DOI: 10.1186/s40345-024-00340-z -
International Journal of Bipolar... May 2024Several genetic studies have been undertaken to elucidate the intricate interplay between genetics and drug responses in bipolar disorder (BD). However, there has been...
BACKGROUND
Several genetic studies have been undertaken to elucidate the intricate interplay between genetics and drug responses in bipolar disorder (BD). However, there has been notably limited research on biomarkers specifically linked to valproate, with only a few studies investigating integrated proteomic and genomic factors in response to valproate treatment. Therefore, this study aimed to identify biological markers for the therapeutic response to valproate treatment in BD. Patients with BD in remission were assessed only at baseline, whereas those experiencing acute mood episodes were evaluated at three points (baseline, 8 ± 2 weeks, and 6 ± 1 months). The response to valproate treatment was measured using the Alda scale, with individuals scoring an Alda A score ≥ 5 categorized into the acute-valproate responder (acute-VPAR) group. We analyzed 158 peptides (92 proteins) from peripheral blood samples using multiple reaction monitoring mass spectrometry, and proteomic result-guided candidate gene association analyses, with 1,627 single nucleotide variants (SNVs), were performed using the Korean chip.
RESULTS
The markers of 37 peptides (27 protein) showed temporal upregulation, indicating possible association with response to valproate treatment. A total of 58 SNVs in 22 genes and 37 SNVs in 16 genes showed nominally significant associations with the Alda A continuous score and the acute-VPAR group, respectively. No SNVs reached the genome-wide significance threshold; however, three SNVs (rs115788299, rs11563197, and rs117669164) in the secreted phosphoprotein 2 gene reached a gene-based false discovery rate-corrected significance threshold with response to valproate treatment. Significant markers were associated with the pathophysiological processes of bipolar disorders, including the immune response, acute phase reaction, and coagulation cascade. These results suggest that valproate effectively suppresses mechanisms associated with disease progression.
CONCLUSIONS
The markers identified in this study could be valuable indicators of the underlying mechanisms associated with response to valproate treatment.
PubMed: 38758284
DOI: 10.1186/s40345-024-00342-x -
Health Affairs Scholar Aug 2023Over the past decade, the age-adjusted suicide rate has increased by 35.2% in the United States. In primary care, practitioners often interact with patients at risk of...
Over the past decade, the age-adjusted suicide rate has increased by 35.2% in the United States. In primary care, practitioners often interact with patients at risk of dying by suicide, yet little is known about the prevalence of suicide risk in primary care populations. Patient data from 2017-2020, consisting of a national sample of patients referred from primary care and enrolled in collaborative care behavioral health services (n = 37 666), were analyzed. Controlling for demographic characteristics, logistic models were used to compare suicide risk prevalence by behavioral health diagnosis. An estimated 9.96% (95% confidence interval [CI]: 9.65-10.27)-or approximately 3751 individuals-of the total sample screened positively for suicide risk. Compared with individuals diagnosed with generalized anxiety disorder, individuals diagnosed with bipolar disorder had 8.21 times the odds (95% CI: 6.66-10.10) of screening for suicide risk. Practitioners and health care systems may benefit from adding suicide risk screeners as a standard practice for referred patients, which may lead to further development of clinical pathways and provider training. The high rate of suicide risk across the sample suggests that more research is needed to understand suicide risk prevalence across primary care and collaborative care populations.
PubMed: 38756240
DOI: 10.1093/haschl/qxad029 -
Health Affairs Scholar Apr 2024Mental health remains an urgent global priority, alongside efforts to address underlying social determinants of health (SDoH) that contribute to the onset or exacerbate... (Review)
Review
Mental health remains an urgent global priority, alongside efforts to address underlying social determinants of health (SDoH) that contribute to the onset or exacerbate mental illness. SDoH factors can be captured in the form of International Classification of Disease, Tenth Revision, Clinical Modification (ICD-10-CM), SDoH Z codes. In this scoping review, we describe current SDoH Z-code documentation practices, with a focus on mental health care contexts. Among 2 743 061 374 health care encounters noted across 12 studies in the United States, SDoH Z-code documentation rates ranged from 0.5% to 2.4%. Documentation often involved patients under 64 years of age who are publicly insured and experience comorbidities, including depression, bipolar disorder and schizophrenia, chronic pulmonary disease, and substance abuse disorders. Documentation varied across hospital types, number of beds per facility, patient race/ethnicity, and geographic region. Variation was observed regarding patient sex/gender, although SDoH Z codes were more frequently documented for males. Documentation was most observed in government, nonfederal, and private not-for-profit hospitals. From these insights, we offer policy and practice recommendations, as well as considerations for patient data privacy, security, and confidentiality, to incentivize more routine documentation of Z codes to better assist patients with complex mental health care needs.
PubMed: 38756172
DOI: 10.1093/haschl/qxae046 -
Anesthesiology May 2024Observational studies of anesthetic neurotoxicity may be biased because children requiring anesthesia commonly have medical conditions associated with neurobehavioral...
BACKGROUND
Observational studies of anesthetic neurotoxicity may be biased because children requiring anesthesia commonly have medical conditions associated with neurobehavioral problems. This study takes advantage of a natural experiment associated with appendicitis, in order to determine if anesthesia and surgery in childhood were specifically associated with subsequent neurobehavioral outcomes.
METHODS
We identified 134,388 healthy children with appendectomy and examined the incidence of subsequent externalizing or behavioral disorders (conduct, impulse control, oppositional defiant, or attention-deficit/hyperactivity disorder); or internalizing or mood/anxiety disorders (depression, anxiety, or bipolar disorder) when compared to 671,940 matched healthy controls as identified in Medicaid data between 2001-2018. For comparison, we also examined 154,887 otherwise healthy children admitted to the hospital for pneumonia, cellulitis, and gastroenteritis, of which only 8% received anesthesia, and compared them to 774,435 matched healthy controls. We also examined the difference-in-differences between matched appendectomy patients and their controls and matched medical admission patients and their controls.
RESULTS
Compared to controls, children with appendectomy were more likely to have subsequent behavioral disorders (the hazard ratio (HR) was 1.04 (95% CI 1.01, 1.06), P = 0.0010), and mood/anxiety disorders (HR: 1.15 (95% CI 1.13, 1.17), P < 0.0001). Relative to controls, children with medical admissions were also more likely to have subsequent behavioral (HR: 1.20 (95% CI 1.18, 1.22), P < 0.0001), and mood/anxiety (HR: 1.25 (95% CI 1.23, 1.27), P < 0.0001) disorders. Comparing the difference between matched appendectomy patients and their matched controls to the difference between matched medical patients and their matched controls, medical patients had more subsequent neurobehavioral problems than appendectomy patients.
CONCLUSIONS
Although there is an association between neurobehavioral diagnoses and appendectomy, this association is not specific to anesthesia exposure, and is stronger in medical admissions. Medical admissions, generally without anesthesia exposure, displayed significantly higher rates of these disorders than appendectomy-exposed patients.
PubMed: 38753986
DOI: 10.1097/ALN.0000000000005075 -
PloS One 2024Human Endogenous Retroviruses (HERVs) are fossil viruses that composes 8% of the human genome and plays several important roles in human physiology, including muscle...
BACKGROUND
Human Endogenous Retroviruses (HERVs) are fossil viruses that composes 8% of the human genome and plays several important roles in human physiology, including muscle repair/myogenesis. It is believed that inflammation may also regulate HERV expression, and therefore may contribute in the muscle repair, especially after training exercise. Hence, this study aimed to assess the level of HERVs expression and inflammation profile in practitioners' resistance exercises after an acute strength training session.
METHODS
Healthy volunteers were separated in regular practitioners of resistance exercise training group (REG, n = 27) and non-trained individuals (Control Group, n = 20). All individuals performed a strength exercise section. Blood samples were collected before the exercise (T0) and 45 minutes after the training session (T1). HERV-K (HML1-10) and W were relatively quantified, cytokine concentration and circulating microparticles were assessed.
RESULTS
REG presented higher level of HERV-W expression (~2.5 fold change) than CG at T1 (p<0.01). No difference was observed in the levels of HERV-K expression between the groups as well as the time points. Higher serum TNF-α and IL-10 levels were verified post-training session in REG and CG (p<0.01), and in REG was found a positive correlation between the levels of TNF-α at T1 and IL-10 at T0 (p = 0.01). Finally, a lower endothelial microparticle percentage was observed in REG at T1 than in T0 (p = 0.04).
CONCLUSION
REG individuals exhibited a significant upregulation of HERV-W and modulation of inflammatory markers when compared to CG. This combined effect could potentially support the process of skeletal muscle repair in the exercised individuals.
Topics: Humans; Endogenous Retroviruses; Resistance Training; Biomarkers; Male; Adult; Inflammation; Female; Young Adult; Tumor Necrosis Factor-alpha; Exercise; Interleukin-10
PubMed: 38753716
DOI: 10.1371/journal.pone.0303798 -
JMIR Mental Health May 2024The care environment significantly influences the experiences of patients with severe mental illness and the quality of their care. While a welcoming and stimulating...
BACKGROUND
The care environment significantly influences the experiences of patients with severe mental illness and the quality of their care. While a welcoming and stimulating environment enhances patient satisfaction and health outcomes, psychiatric facilities often prioritize staff workflow over patient needs. Addressing these challenges is crucial to improving patient experiences and outcomes in mental health care.
OBJECTIVE
This study is part of the Patient-Reported Experience Measure for Improving Quality of Care in Mental Health (PREMIUM) project and aims to establish an item bank (PREMIUM-CE) and to develop computerized adaptive tests (CATs) to measure the experience of the care environment of adult patients with schizophrenia, bipolar disorder, or major depressive disorder.
METHODS
We performed psychometric analyses including assessments of item response theory (IRT) model assumptions, IRT model fit, differential item functioning (DIF), item bank validity, and CAT simulations.
RESULTS
In this multicenter cross-sectional study, 498 patients were recruited from outpatient and inpatient settings. The final PREMIUM-CE 13-item bank was sufficiently unidimensional (root mean square error of approximation=0.082, 95% CI 0.067-0.097; comparative fit index=0.974; Tucker-Lewis index=0.968) and showed an adequate fit to the IRT model (infit mean square statistic ranging between 0.7 and 1.0). DIF analysis revealed no item biases according to gender, health care settings, diagnosis, or mode of study participation. PREMIUM-CE scores correlated strongly with satisfaction measures (r=0.69-0.78; P<.001) and weakly with quality-of-life measures (r=0.11-0.21; P<.001). CAT simulations showed a strong correlation (r=0.98) between CAT scores and those of the full item bank, and around 79.5% (396/498) of the participants obtained a reliable score with the administration of an average of 7 items.
CONCLUSIONS
The PREMIUM-CE item bank and its CAT version have shown excellent psychometric properties, making them reliable measures for evaluating the patient experience of the care environment among adults with severe mental illness in both outpatient and inpatient settings. These measures are a valuable addition to the existing landscape of patient experience assessment, capturing what truly matters to patients and enhancing the understanding of their care experiences.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02491866; https://clinicaltrials.gov/study/NCT02491866.
Topics: Humans; Male; Psychometrics; Female; Adult; Middle Aged; Cross-Sectional Studies; Mental Disorders; Patient Satisfaction; Patient Reported Outcome Measures; Reproducibility of Results; Surveys and Questionnaires
PubMed: 38753416
DOI: 10.2196/49916