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Showing 1-12 of 12 trials
NCT07589647
This study aims to stabilize the patients with bipolar disorder (BD) comorbid with obesity in the stable phase by using temporal interference stimulation (TIS ) intervention. It intends to investigate the changes in key metabolic molecules such as GLP-1 circadian rhythm, and further explore the molecular mechanism of their metabolic disorders.
NCT07445802
People living with serious mental illnesses such as schizophrenia and bipolar disorder often need long-term medication to stay well. However, many patients have difficulty taking medication regularly, which can increase the risk of relapse, hospitalization, and poorer quality of life. Traditionally, treatment adherence has been measured using self-report questionnaires, which may be influenced by memory or social desirability bias. With the recent expansion of electronic prescription systems in Spain, it is now possible to objectively verify whether patients collect their medications from the pharmacy. This provides a new opportunity to better understand and support treatment adherence. The ADHERA study will evaluate how well digital self-report questionnaires reflect real medication use compared with electronic dispensing records. We will also explore patient characteristics that may be associated with difficulties in medication adherence. Finally, we will test a new online psychoeducational program-including sessions led by mental health professionals and supported by peer-experience contributors-to determine whether it can help improve adherence. Participants with schizophrenia or bipolar disorder who are registered in the hospital's digital patient portal and have active antipsychotic prescriptions will be invited to complete brief adherence questionnaires online. Individuals with signs of reduced adherence will then be invited to take part in a telehealth intervention consisting of ten group sessions, where they will receive information, support, and practical strategies to maintain their treatment plan. Medication adherence will be reassessed after six months. If successful, this study may help improve how treatment adherence is measured in clinical practice, guide targeted interventions for individuals at higher risk of non-adherence, and provide evidence for scalable telehealth programs that can be easily implemented in other regions and medical conditions
NCT06488573
Individuals with Bipolar Disorder (BD) have twice the risk of being affected by metabolic comorbidities and a 1.8-fold increased risk of mortality from cardiovascular diseases when compared to the general population. These factors are fundamental in the 14-year reduction in the life expectancy of people with TB reported in recent meta-analyses. This occurs mainly due to the increased inflammation associated with the disease, the adverse effects of pharmacological treatments and unhealthy lifestyle habits that are more common in people diagnosed with BD. Nutrition has been studied as an adjunctive treatment in other psychiatric disorders, but there is a lack of studies about the role of nutrition in TB. Considering that diet can impact metabolic health, this randomized controlled study aims to evaluate the effect of a nutritional intervention on cardiovascular risk in patients with TB. The intervention is based on the dietary pattern recommended in the Dietary Guidelines for the Brazilian Population and will be applied by a registered dietitian. According to the literature, the sample size will be 72 individuals with TB (36 in the control group with usual treatment + 36 in the intervention group added to the usual treatment). The intervention will be carried out in 7 individual sessions and 8 group sessions with specific themes. The primary aim of this protocol will be an intervention to contribute to cardiovascular health - verified by serum markers, anthropometric measurements and the Framingham Cardiovascular Risk Score (algorithm used to estimate an individual's 10-year cardiovascular risk). The secondary stages will be the adherence of the intervention and the impact on the quality of life of the participants. The possible positive results of this nutritional intervention can open new clinical perspectives. Meaning that might show that better food choices can protect the cardiovascular health of individuals with TB, leading to a reduction in morbidity and mortality associated with the disease.
NCT07404085
The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood disorders (depression or bipolar disorder). The investigators hypothesize that the VR-based cognitive remediation training (VR-CRT) combined with HDACi butyrate vs. a VR-based control treatment combined with placebo will improve global cognition (primary outcome measure) over three weeks. Secondly, the investigators hypothesize that VR-CRT with placebo will improve cognition relative to the VR control treatment with placebo, although to a lesser extent than VR-CRT with HDACi butyrate. Thirdly, the investigators hypothesize that the HDACi butyrate with VR control treatment will not produce cognitive improvements relative to placebo with VR control treatment. Finally, the investigators hypothesize that the combined treatment (VR-CRT + HDACi butyrate) will enhance neuroplasticity (exploratory outcome) vs. VR control with placebo, as indicated by increase in hippocampal volume and/or memory-related activity shown with structural and functional MRI.
NCT07295652
Neuropsychiatric disorders are extremely common, severe, and disabling conditions. In the field of psychiatry, they notably include schizophrenia, mood disorders (depressive and bipolar disorders), autism spectrum or neurodevelopmental disorders, obsessive-compulsive disorder, eating disorders, and personality disorders. In the field of neurology, one can cite neurodegenerative diseases (such as Alzheimer's disease, but also frontotemporal dementia or Parkinson's disease, which often represent frequent and challenging differential diagnoses of psychiatric disorders), focal neurological lesions (notably strokes and tumors), or epilepsy. Cognitive impairments are present in nearly all neuropsychiatric disorders and contribute significantly to disability. While impairments in working memory and attention, executive functions, and social cognition have been relatively well studied, other cognitive domains remain largely unexplored in these populations. This is particularly the case for various aspects of motivation, metacognition, conscious access, or causal (Bayesian) inference. Although these domains likely play an important role in prognosis, no consensus currently exists regarding the methods for evaluating these functions. The main objective of this study is to define a multidimensional, transdiagnostic atlas of high-level cognitive impairments-both specific and shared-across severe psychiatric disorders (notably schizophrenia, depressive disorder, bipolar disorder, autism spectrum or neurodevelopmental disorders, and obsessive-compulsive disorder) and neurological disorders (notably neurodegenerative diseases, focal neurological lesions, and epilepsy), by comparing them to healthy volunteers. The investigators also aim to investigate the progression of cognitive impairments over time, across different phases of illness (symptom stabilization or exacerbation) or therapeutic intervention, through longitudinal follow-up of patients being monitored within the recruiting center. Finally, in a more exploratory manner, the investigators aim to investigate the neural correlates of the identified cognitive impairments.
NCT07031817
The goal of this interventional clinical trial is to assess the diagnostic performance of a composite diagnostic medical devise based on blood-based in vitro diagnostic device and Mood Disorder Questionnaire (MDQ) in identifying bipolar disorder among adult patients presenting with a current major depressive episode in primary care. The study will compare the results of the medical device diagnostic test to those of standardized psychiatric clinical evaluation, to evaluate its sensitivity, specificity, and overall clinical utility. The main research questions are : * Can the investigational medical device accurately distinguish bipolar disorder from unipolar depression ? * How does its diagnostic accuracy compare with validated psychiatric questionnaires commonly used in clinical practice ? Participants will : * Provide a blood sample for biomarker analysis using the investigational diagnostic device. * Complete a few validated psychiatric assessment tools (e.g., MDQ, MINI). * Share sociodemographic and clinical data relevant to psychiatric evaluation.
NCT07167563
The aim of the present study is to study compliance with lithium therapy and patterns of lithium intake among a representative group of patients with bipolar disorder in a real-world clinical setting. This will be studied via a pill box that registers the daily time when the participant took the lithium tablet out of the pill box, representing a proxy for the actual lithium intake. Participants will receive a weekly phone call asking for several aspects of lithium intake.
NCT06878937
Self-management strategies can be used by individuals with bipolar disorder (BD) to cope with symptoms and improve quality of life (QoL). Peer-facilitated education programs have the potential to diversify delivery of self-management information by capitalizing on the expertise of individuals who live well with BD. We have co-designed a novel, peer-facilitated, QoL-focused, group education program for people living with BD. This project will involve administration of the program and an evaluation of the feasibility, acceptability, and efficacy of this program for self-management of BD.
NCT06968598
Demonstrate the existence of neurodevelopmental alterations in organoids derived from samples of patients with bipolar disorder (BD) with a neurodevelopmental (ND) component, compared with patients with bipolar disorder (BD) without an ND component.
NCT06829316
Aim of Study: * To assess DNA methylation of the IL1-B gene in individuals with BD compared to healthy controls. * To evaluate the expression of 5-hydroxytryptamine (serotonin) receptors in BD and shed more light into its role into the pathophysioogy of BD. * To measure differences of glutamic acid levels between study groups. * To investigate correlations between these biomarkers among study groups, and their alignment with clinical presentations.
NCT06729541
Schizophrenia (SCH), major depressive disorder (MDD), and bipolar disorder (BPD) are prevalent, disabling psychiatric conditions that not only cause significant suffering for affected individuals and their families but also impose a substantial socioeconomic burden and challenge societal well-being. Addressing the mental health challenges faced by patients, their families, and the healthcare system is a critical global public health priority. However, a comprehensive and systematic precision treatment approach for mental disorders remains largely absent in current clinical practice. This study leveraged pharmacogenomic insights tailored specifically to the Chinese Han population to guide individualized medication selection. The approach incorporated quantitative assessment-based treatment protocols alongside therapeutic drug monitoring throughout the treatment process. The overarching goal was to establish a systematic precision treatment model that integrates "quantitative assessment-based treatment + pharmacogenomics + therapeutic drug monitoring." This model aims to optimize treatment outcomes, enhance safety, improve efficiency, and reduce costs, ultimately benefiting patients with psychiatric disorders.
NCT06662526
INTRODUCTION: Mood disorders, bipolar disorder and recurrent unipolar depression, are among the most common mental health conditions worldwide. Patients with mood conditions are considered a high-risk group for cognitive impairment. Specifically, the risk estimates for developing dementia range from 1.90 to 3.02 for MDD, and 2.36 to 5.58 for mood conditions. Mild cognitive impairment (MCI), is an intermediate stage between the expected cognitive decline of normal aging and the more serious decline of dementia. On the other hand, Lithium has long been recognized as the gold standard treatment for mood conditions and the eventual effect as neurocognitive agent. It has been reported that long-term treatment with lithium decreased the prevalence of dementia compared to patients not receiving lithium treatment. The prevalence of Alzheimer is lower in patients with bipolar disorder who are on chronic lithium therapy compared to those who are not, and low-dose lithium (from 300 mcgr to 50 mg/day) may provide neuroprotective benefits without significant side effects. This trace dosage is hypothesized to be sufficient to activate neuroprotective pathways while minimizing toxicity. AIM: to investigate the effect of trace dosage of lithium on cognitive function in individuals at risk of developing these conditions. Specifically, this study will randomize healthy participants and patients with mild cognitive impairment to receive either a low-dose lithium supplement (50 mg daily) or a placebo, with the primary outcome being the incidence of MCI or worsening of the preexisting MCI. HYPOTHESIS: Patients with mood conditions exposed to trace lithium dosage will have a smaller incidence of MCI or less worsening of the preexisting MCI compared with patients receiving placebo. GOALS: A)To examine the effectiveness of lithium in prevention of mild cognitive impairment in patients with the high-risk factor of preexisting mood illnesses (i.e., unipolar depression or bipolar illness). The primary outcome is incidence of newly diagnosed mild cognitive impairment (MCI) or worsening of preexisting MCI. B) To assess, in an exploratory analysis, the clinical predictors of good lithium response in this sample. These analyses will also assess lithium effects on suicide, mortality, quality of life, functional impairment, and overall medical morbidity. METHODOLOGY: The study will be double-blind randomized placebo-controlled trial. Patients will be recruited from two sites in Santiago, Chile, the Psychiatric Institute Dr. José Horwitz Barak and the Psychiatric Clinic of the University of Chile. Subjects aged 55 to 75 years, who present mood disorders and are not currently on lithium therapy, will be invited to participate. Inclusion Criteria are: Age 55-75, DSM-5 diagnosis of major depressive disorder or bipolar disorder (types I or II), current or lifetime, prior to participation in this study, each subject must sign an informed consent. Exclusion Criteria are: current mood treatment with lithium, alcohol dependency within the past month, current serious unstable medical conditions or history of medical illness that would contraindicate a trial of lithium, current or past severe kidney disease or baseline creatinine higher than 1.5 mg/dl, active suicidal ideation with plan and intent (Columbia Suicide Severity Rating Scale Screen Version (C-SSRS Screen) higher than points), current or past severe thyroid disease or baseline TSH higher than 5.0 uUI/dl, current diagnosis of dementia of any kind. Participants will be randomized into one of two arms: a trace dose lithium or placebo, each group consisting of 125 subjects. Block randomization will be stratified by diagnosis (bipolar vs MDD), gender, decade of age, and presence or absence of any baseline cognitive impairment Interventions. All participants will receive their usual clinical medical treatment during the time the study is conducted. All psychotropic medications will be allowed to be given per standard of care except lithium. The study defined randomization to lithium or placebo arms as adjuncts to other medications. Intervention arm will consist in lithium 50 mg oral tablets per day (trace doses). Control arm will consist in placebo tablet. OUTCOME: The primary outcome measure will be the incidence of Mild Cognitive Impairment (MCI) or worsening of preexisting MCI at one, three, and four years. This primary outcome will be defined as change from patients initially with a Clinical Dementia Rating Scale (CDR) score of 0 to 0.5 (MCI) or patients initially with a score in the CDR of 0.5 that change to 1. (worsening of MCI). The primary analysis will employ a Cox regression model to analyze the time to first clinical diagnosis of MCI or worsening of MCI.