Effects of Gene Polymorphisms on Metabolic Features in Clozapine-treated Patients With Schizophrenia...
SchizophreniaSchizoaffective DisorderThe investigators would like to know the association of gene polymorphisms and metabolic adversities in clozapine-treated patients with schizophrenia in Taiwan.
An Adherence Study of Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective...
SchizophreniaSchizoaffective DisorderThis prospective study examines the differences among several measures of adherence to antipsychotic medications in outpatients with schizophrenia. Adherence is assessed by using self-report, physician report, pill count and electronic monitoring. The rates of adherence/non-adherence with various tools will be manifested. The association between antipsychotic adherence/non-adherence and various clinical status, including psychotic symptoms, depressive symptoms, side effects, neurocognitive function and insight are analyzed. Participants are assessed at baseline during a visit to their outpatient clinic and followed up for 8 weeks.
Imaging Synapses With [11C] UCB-J in the Human Brain
SchizophreniaThe purpose of this study is to utilize the radioactive positron emission tomography (PET) tracer [11C]UCB-J to test the neural synaptic pruning hypothesis of schizophrenia. This imaging method allows for the quantification of synaptic density in the living human brain and has the unprecedented ability to directly examine the synaptic pathology underlying neuropsychiatric disease. The neural synaptic pruning hypothesis posits that a key pathogenic process of schizophrenia is the over-exuberant elimination of neural synapses during development. The confirmation of reduced synaptic density in schizophrenia as evidenced by [11C]UCB-J has the potential to lead to a number of ground-breaking clinical innovations, such as laboratory-based diagnostics and prognostics, and novel, disease-modifying treatments.
Quantitative Investigation of Environment and Participation
Supported Accommodation ResidentsSchizophrenia3 moreSupported accommodation provides individuals with complex mental health difficulties the opportunity to maintain a tenancy with different levels of staff support provided to develop and maintain living skills and engage in social and work activities. Physical features of the place people live, the support they receive from staff and the individuals needs all have the potential to impact on their ability to engage in activities that enable then to have increasing independence within the community. The study will investigate the relationship between the physical and social features of supported accommodation environments and whether this facilitates or inhibits people with complex mental health difficulties' participation in everyday life, relationships, pursuing interests and work. The study will also consider whether people's needs have an effect on the relationship between the environment and their participation. The study will analyse data collected using measures of clients' levels of participation, features of the supported accommodation environment and how needs mediates this relationship. The aim is to inform ways of working with people with complex mental health difficulties in supported accommodation that increase opportunities for participation in the activities they need, want and enjoy doing.
Survey on Pre-ECT Evaluation and ECT Application
DepressionCatatonia4 moreThe aim of this study is to identify specifics of pre-ECT assessments and ECT application in European psychiatric services. We will engage European centres that provide ECT for psychiatric patients and for psychiatric indications. It could bring better insights on current standards and possibly give some further improvements in the field of European ECT practices.
Community-based Mental Health Care for People With Severe and Enduring Mental Ill Health (RECOVER-E)...
Severe Mental DisorderSchizophrenia2 moreTo contribute to improving the level of functioning and quality of life and mental health outcomes for people with severe and enduring mental ill health (SMI) (schizophrenia, bipolar disorder, depression) by adapting and up scaling the implementation of a community-based service delivery model in Croatia.
A Study in Italy About Evidence Based Psychosocial/Rehabilitative Interventions in Patients With...
SchizophreniaThis is a prospective, observational, naturalistic study conducted according to Italian law. The Investigators are interested in observing how often Evidence Based (EB) psychosocial and rehabilitative interventions are actually offered to patients in the real world clinical practice of psychiatric Italian services able to deliver this kind of treatments, focusing on a cohort of patients with recent onset schizophrenia, for whom delivery of integrated treatments is especially recommended, treated continuously with Long Acting Injection (LAI) antipsychotics. The primary objective of this study is to explore the level of implementation of EB psychosocial/rehabilitative treatments during a prospective 12-month period in patients with recent onset schizophrenia (≤ 5 years) being treated with a LAI Antipsychotic in Psychiatric Departments with expertise in the application of such interventions and to describe the reasons of implementing the particular EB psychosocial intervention and the clinical-functional characteristics of patients assigned to them. The prospective design is strictly required both for allowing consistent definition and application of such interventions and for describing reliably the characteristics of patients assigned to them. Secondary objectives are to describe the reasons for the choice of the specific assigned psychosocial intervention (if any) and the clinical and functional treatment outcomes of patients assigned or not-assigned to EB psychosocial therapies.The assignment of a patient to any particular treatment is not decided in advance by the study protocol, but falls within current clinical practice. Inclusion criteria are: Patients with schizophrenia (F20 according to ICD-10 version 2013) Onset of schizophrenia, defined as the first onset of symptoms that required specific antipsychotic treatment or hospitalization, as derived from anamnesis or available clinical documentation, not more than 5 years before study entry Age between 18 and 40 years Patients under treatment with a LAI on the basis of physician's decision (LAI started no longer than 6 months before study entry) and clinically stable (no relapse requiring hospitalization or change of treatment due to clinical worsening) during the last 1 month. Primary outcome of interest ("endpoint") is percentage of patients within the total study population who have been assigned to any EB psychosocial/rehabilitative treatment (listed below) for at least 1 month consecutively during the 12-month observation period (given the heterogeneity of interventions, this is an arbitrary duration which may reliably indicate a significant exposure to a given intervention). The percentage of each type of psychosocial intervention delivered together with frequency of sessions and length of treatment, and the reasons (categorized) given by the clinicians to justify the selected psychosocial intervention as well as the clinical-functional characteristics of patients assigned to them will be described. Patient assignment to the different interventions and their delivery will be traced in the patients' clinical charts. A list of key-words to describe each intervention will be provided in order to identify reliably and univocally the activities delivered. Secondary endpoints: Sociodemographic information Percentage of patients assigned during the 12-months period to at least one non EB intervention for at least 1 month consecutively (given the heterogeneity of interventions, this is an arbitrary duration which may reliably indicate a significant exposure to a given intervention) but not to any of the EB interventions. Percentage of relapses % of patients who discontinue drug treatment (for ineffectiveness, side effects or other reasons and patient/physician decision) and/or psychosocial interventions (for team or patient decision) Changes in clinical, cognitive, functional and quality of life measures Additional endpoints: - Health economic information collected through 3 specific questionnaires: detection of i) health resources consumption for the care of the disorder (direct costs, eg. drug cost, hospitalization, emergency visits, Day hospitals, General Physician visits…) and assessment of indirect costs through evaluation of : ii) patient's potential income loss, absenteeism and presenteeism to estimate work productivity, daily activity impairment due to the mental illness and of iii) caregiver's potential income loss, commitment of time for the patient's care, absenteeism and presenteeism to estimate work productivity, daily activity impairment because of the patient's mental illness
Therapeutic Drug Monitoring for Individualized Clozapine Therapy
SchizophreniaThe purpose of this study is to evaluate the factors affecting the occurrence of adverse drug reactions (glucose and lipid metabolism abnormality, changes in liver function index and sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment
Social Isolation and Loneliness in Older People
Very Late Onset SchizophreniaAlthough psychotic disorders such as schizophrenia usually present in late adolescence or early adulthood, research suggests that a substantial subset of people are diagnosed for the first time after the age of 60. This condition is referred to as 'very late-onset schizophrenia-like psychosis' (VLOSLP). People with VLOSLP are thought to experience high levels of social isolation, yet there has been little research systematically examining this. Additionally, little is known about how lonely people with VLOSLP feel, or how this group relate to and perceive other people. This study aims to examine levels of social isolation and loneliness in patients with VLOSLP. The investigators also aim to explore aspects of social cognition in relation to VLOSLP. A case-control study design will be used to examine the relationship between VLOSLP, loneliness, social isolation and social cognition. The case group will be people diagnosed with a non-organic psychotic disorder after age 60. The comparison group will be those aged 60 and above in contact with mental health services for a mental health difficulty, except from a psychotic disorder or dementia.
Phenomics and Genomics of Clozapine Pharmacotherapy
Schizophrenia Spectrum and Other Psychotic DisordersA burgeoning body of research has pointed to increased efficacy of clozapine (CLZ) over other antipsychotics in schizophrenia (SCZ). On the other hand, safety concerns likely cause underutilization across a range of European and other nations. The lack of data available to predict efficacy and adverse drug reactions (ADRs) of CLZ further contributes to underprescription rates in these countries. Here, we hypothesize that (epi)genetic and non-genetic factors aid to help predict treatment outcome (efficacy + ADRs) to CLZ. We furthermore posit that such prediction will result in enhanced quality of life of both patients and family members. Our primary objective is to predict CLZ treatment outcome based on phenotypic and genetic data obtained through the current design. The first secondary objective is to investigate which methylation levels/patterns are correlated with CLZ treatment outcome. The second secondary objective is to aid in the further elucidation of the genetic architecture of SCZ and any possible differences between 'regular' SCZ patients and those on CLZ, who are generally more severely ill. We thus intend to cover two currently unmet needs using a precision medicine approach: the lack of knowledge about determinants of treatment response to CLZ and the lack of insight into neurobiological differences between 'regular' SCZ and relatively treatment resistant subjects (CLZ users). The prime analysis will be a common variant hypothesis-generating genotyping endeavor investigating treatment response to CLZ. Additional analyses include whole-genome methylation and gene expression analyses and analyses of non-genetic determinants of response. We will include 2,500 CLZ treated patients for our discovery cohort, which is in line with previous whole-genome pharmacogenomics studies and our power calculations. We will replicate any genome-wide loci using our prospectively collected cohort of new users (N=59). Potential yields include a publicly available prediction tool to help identify patients responsive to CLZ in early disease stages and prevent harmful effects. In addition, common variant analyses compounded by pathway analyses may help elucidate the mechanisms of action of CLZ. We ask for broad informed consent from participants ensuring rich, longitudinal phenotypic and genotypic data resources for both currently planned and future analyses, allowing e.g. next-generation sequencing focused on both CLZ and SCZ disease genetics (e.g. in large consortia). We plan to also generate polygenic risk scores (PRS) of CLZ efficacy and use those to identify other diseases or patients for which CLZ may be helpful, e.g. schizoaffective disorder patients who are sometimes first treated with mood stabilizers. Last, evidence hints that disparaging genetic loci influence efficacy to different antipsychotics. Adding genetic data from our cohort to existing datasets of response to other antipsychotics may help identify such loci. Finally, comparison studies with non-CLZ using patients suffering from SCZ may deepen the understanding of biological mechanisms underlying treatment resistance (or: a relatively severe course of illness).The results of this genetic part of the study will be combined with the results from our other research protocol 'Phenomics and genomic of clozapine pharmacotherapy - New Users'.The overarching goal of both projects is to create a prediction model for clozapine outcome (response (and side effects). This model includes genetic, epigenetic and clinical data.