Active clinical trials for "Schizophrenia"

Schizophrenia has very significant economic consequences. Costs fall on many different parts of society, especially on individuals with schizophrenia and their families. The first five years after onset appears to be a critical period in which the symptoms are more responsive to treatment. In addition, if left untreated for a long time, psychosis can impact many areas of a person's life. The evidence base regarding the effectiveness of specialist early intervention services for psychosis has grown steadily and evidence from randomized controlled trials in Denmark, the United Kingdom and Spain has demonstrated the superiority of specialized early intervention programs over standard care on a broad range of outcomes including symptomatic and vocational, social functioning, and reduced inpatient care and treatment dropout, as measured over follow-up intervals of 2-3 years. Information about the cost-effectiveness of early intervention programs for first-episode psychosis is limited. The provision of such services requires investment by health departments and services, and the question of whether such services represent value for money has to date received little research attention. Only a few international studies, and none conducted in Spain, have investigated the cost effectiveness of early intervention in psychotic disorders at medium (3 years) and long-term (up to 10 years). In this study, the investigators aimed to analyse the cost-effectiveness of an intensive early-intervention programme, using data from First Episode Psychosis Clinical Program (PAFIP), the largest trial treating first episode non-affective psychosis in Spain to date.

The purpose of the study is to investigate these effects of Second-Generation Antipsychotic (SGAs) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore the relationship between genes polymorphisms (such as drug metabolic enzyme, Endogenous Cannabinoid Receptor Type 1(CB1) and so on) and the SGAs-induced glucose and lipid metabolic disorder in Chinese Han persons with schizophrenia who are taking one of the SGAs(olanzapine, risperidone or ziprasidone).

Background: Schizophrenia is a serious mental illness. The diagnosis and severity evaluations of schizophrenia are generally based on patient behaviors. Biomarkers are objectively measured and used as indicators for diagnosis confirmation, symptom assessment, and evaluation of pharmacologic responses to therapeutic interventions. Neuroendocrine and metabolite substrates are potential biomarkers of the pathogenic processes in schizophrenia. Aims: The aims of this study are to determine (a) the differences in neuroendocrine and metabolite substrates between patients diagnosed with schizophrenia and healthy controls; and (b) the associations among the neuroendocrine and metabolite substrates, cognitive function, clinical symptoms, and treatment responses of patients diagnosed with schizophrenia. Methods: (a) The investigators plan to recruit 100 patients diagnosed with schizophrenia and 100 healthy controls as participants. (b) At the baseline and Week 12, patient blood samples will be obtained to measure the levels of neuroendocrine substrates and metabolite markers. Clinical symptoms and cognitive function will be evaluated. (c) For the healthy control participants, blood samples will be obtained once to measure neuroendocrine and metabolite marker levels. Expected Results: The results of this study may contribute to identifying potential neuroendocrine and metabolite biomarkers of schizophrenia, and clarify the associations among the neuroendocrine and metabolite substrates, cognitive function, clinical symptoms, and treatment responses of patients diagnosed with schizophrenia. Such information is crucial for clinical evaluations and future research.

This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications that propose to enrich pre-existing resources for schizophrenia in the National Institute of Mental Health (NIMH) Human Genetics Initiative and to apply genomic methods to further the investigators understanding of the molecular etiology of the disorder. The overarching aims of this proposal are to quickly and cost-effectively ascertain a large sample of trio families affected by schizophrenia, and to discover causal variants for the disorder in the first family-based genome-wide association study (GWAS) of the disorder. In Taiwan, there is no such kind of policy to support this kind of GWAS study as it is a very expensive study, including collecting large family samples and genome-wide single-nucleotide polymorphism (SNP) scanning. The investigators, thus, collaborate with Professor Ming T, Tsuang and his entended subcontracted researchers to apply for this project. The investigators, the research team in Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia. Through additional ascertainment within this framework, the investigators will collect an aggregate sample with adequate power for detecting in a GWAS those variants that make even small contributions to the risk for the disorder. The investigators will meet the overarching goals of this project by accomplishing several Specific Aims, as follows: 1) Rapidly ascertain schizophrenia trio families from Taiwanese clinical ascertainment sites; 2) Supplement NIMH Genetics Initiative collections by sending all clinical data and biomaterials to the appropriate repositories; 3) Assess the association of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms (SNPs) and their constituent haplotypes; 4) Analyze quantitative schizophrenia phenotypes such as age at onset ; 5) Perform a genome-wide survey for copy-number variations related to schizophrenia; 6) Test for gene-gene interactions (epistasis); and 7) Test for gene-environment interactions, such as the well-established effect of season of birth.

To examine the feasibility of molecular imaging markers in clinical psychopharmacology

This proposal responds to Request for Applications RFA-MH-08-131, which seeks applications that propose to enrich pre-existing resources for schizophrenia in the NIMH Human Genetics Initiative and to apply genomic methods to further our understanding of the molecular etiology of the disorder. The overarching aims of this proposal are to quickly and cost-effectively ascertain a large sample of trio families affected by schizophrenia, and to discover causal variants for the disorder in the first family-based genome-wide association study (GWAS) of the disorder. In Taiwan, there is no such kind of policy to support this kind of GWAS study as it is a very expensive study, including collecting large family samples and genome-wide SNP scanning. The investigators, thus, collaborate with Professor Ming T, Tsuang and his intended subcontracted researchers to apply for this project. The investigators, the research team in Taiwan, will collect 3800 trio families (11400 subjects) of schizophrenia. The investigators will meet the overarching goals of this project by accomplishing several Specific Aims, as follows: 1) Rapidly ascertain schizophrenia trio families from Taiwanese clinical ascertainment sites; 2) Supplement NIMH Genetics Initiative collections by sending all clinical data and biomaterials to the appropriate repositories; 3) Assess the association of schizophrenia with a genome-wide panel of single-nucleotide polymorphisms (SNPs) and their constituent haplotypes; 4) Analyze quantitative schizophrenia phenotypes such as age at onset ; 5) Perform a genome-wide survey for copy-number variations related to schizophrenia; 6) Test for gene-gene interactions (epistasis); and 7) Test for gene-environment interactions, such as the well-established effect of season of birth.

Theory of mind (TOM), a main component of social cognition processes, refers to the capacity to infer one's own and other person's mental states. Deficits in social cognition are found in patients with schizophrenia and bipolar disorder. The purpose of this study is to compare the neurofunctional profiles of schizophrenic patients, bipolar patients and healthy participants during the performance of a TOM task. Results may help to understand the neural bases of the impairments in social cognition in schizophrenia and bipolar disorder, which may in turn help to propose potential new psychosocial therapeutic approaches in these disorders.

The purpose of this study is to investigate the efficacy and safety of long-term psychopharmacotherapy in schizophrenia or bipolar disorder in terms of psychopathology and side effects.

This project entitled "A Study on Risk Mutations of the Vulnerability Genes of Schizophrenia" (RIGOS) is a continuous effort following the well founded and arduous work of genetic study on schizophrenia (SCH) by the Genomic Psychiatry Study Group (GENOP) of National Taiwan University Hospital. So far the GENOP has established several important data banks, including DNA bank and lymphoblastoid (EVB transformed) cell bank of 725 affected sib-pair SCH families, 200 Trio SCH families, and 150 normal controls; and the clinical database of serial follow-ups. An ongoing project, Positional Cloning Study on the Vulnerability Genes of SCH (POCOS), carried out by the GENOP has found 11 candidate vulnerability genes with identified expression in the brain. Besides, on the basis of two related projects, the Multiple Psychopathological Study of SCH (MPSS) and the Etiological Study on SCH (SEFOS), the GENOP has established endophotype indicators for schizophrenia in neuropsychological and neurophysiological domains. The GENOP, a multidisciplinary research team, is thus ready to search for risk mutations of the candidate vulnerability genes for schizophrenia in this new proposal. The basic strategy of this RIGOS Project is to search for risk mutations, based on case-control design with sufficient statistical power, and then to validate these risk mutations by convergent evidence of genetic epidemiological analyses, functional variation studies using in vitro cell line experiments, microarray study, and neurophysiological study (PPI) on mice model. Thus, this RIGOS Project has integrated 5 lines of experimental designs to achieve 5 specific aims to identify and validate the risk mutations from 11 candidate vulnerability genes found in the ongoing POCOS project based on Taiwanese Sample. We are confident to be at the frontier work of searching for the risk mutations, with functional validity, of SCH. The achievement of the RIGOS will be a mile stone to create new era of genetic functional study to tackle pathophysiological mechanism of SCH and will be the basis of developing novel diagnostic method and novel intervention method at the early stage of SCH in the future.

This PPG entitled "A Study on Psychopathological Progress of Early Schizophrenia-like Disorder (SOPRES)" is designed to study the "Progress of Psychopathology" of pre-psychotic state of schizophrenia (SCH) using a prospective follow-up design. Based on the neurodevelopment hypothesis of schizophrenia, the neurobiological dysfunctions, such as cognitive impairment, neurophysiological dysfunction, neuroanatomical pathology, is the core pathology. The pathology may exist prior to onset of psychotic symptoms, and at post psychotic state. It also presents in the first-degree relatives. SCH is mainly with a gradual mode of onset, ranging from pre-schizotypal (or pan-neurotic state), schizotypal, prodromal to frank psychotic SCH (DSM-IV criteria) state. Up to the present time, there are arbitray criteria for diagnosing schizotypal disorder and frank psychiatric schizophrenia, but the valid clinical assessment method of pre-schizotypal and prodromal state is still controversial. The psychopathological progress from pre-schizotypal to frank psychotic SCH state is still unclear. In this SOPRES, we intend to establish a set of valid clinical assessments for defining the cases of early SCH-like disorder [ESLD], to examine the clinical progression, such as conversion rate of psychosis from non-psychotic state in a prospective longitudinal follow-up; to validate the clinically defined cases of ESLD with different dimensions of neurobiological studies, including niacin skin flush test, neuropsychological, neurophysiological (such as prepulse inhibition [PPI], P50 inhibition [P50I]), and magnetic resonance spectrometry (MRS) and Diffusion Tensor Imaging (TDI); to demonstrate the validity of the ESLD using the family genetic-epidemiological data and to explore the awareness, reaction, coping strategy, social stigma, and help seeking process of the patients and the families of ESLD. In order to achieve these goals, we designed this PPG of SOPRES, which comprises of 4 inter-locked projects and one core unit. Project No.1 is the "Clinical Phenomenological Follow-up Study of ELSD: Clinical Validity"; Project No. 2 is the "Validity Study of Neurobiological Tests of ELSD"; Project No. 3 is the "Validity Study of Family Genetic Study of ELSD"; and Project No. 4 is the "Awareness and Pathways of Help Seeking of ELSD". The only one core unit is designed for the purposed of monitoring research progress, communication among researchers such managing PPG research meeting, data management, and budget management and other research-related administrative secretary work. These 4 projects are integrated study approaches by means of (1) using the same samples; (2) study different levels of psychopathology, including clinical symptoms, neurobiological impairment, family genetic data, and psychosocial variables; and (3) mutual hypothesis testing. We expect that this SOPRES research will create a new frontier of SCH research in the fields of early intervention of SCH for preventing the recurrence of frank psychotic state of schizophrenia, and will provide the background for improving treatment outcome and quality of life of SCH.