Abstract:
:On September 18, 2007, a collaborative session between the International Society for CNS Clinical Trials and Methodology and the International Society for CNS Drug Development was held in Brussels, Belgium. Both groups, with membership from industry, academia, and governmental and nongovernmental agencies, have been formed to address scientific, clinical, regulatory, and methodological challenges in the development of central nervous system therapeutic agents. The focus of this joint session was the apparent diminution of drug-placebo differences in recent multicenter trials of antipsychotic medications for schizophrenia. To characterize the nature of the problem, some presenters reported data from several recent trials that indicated higher rates of placebo response and lower rates of drug response (even to previously established, comparator drugs), when compared with earlier trials. As a means to identify the possible causes of the problem, discussions covered a range of methodological factors such as participant characteristics, trial designs, site characteristics, clinical setting (inpatient vs outpatient), inclusion/exclusion criteria, and diagnostic specificity. Finally, possible solutions were discussed, such as improving precision of participant selection criteria, improving assessment instruments and/or assessment methodology to increase reliability of outcome measures, innovative methods to encourage greater subject adherence and investigator involvement, improved rater training and accountability metrics at clinical sites to increase quality assurance, and advanced methods of pharmacokinetic/pharmacodynamic modeling to optimize dosing prior to initiating large phase 3 trials. The session closed with a roundtable discussion and recommendations for data sharing to further explore potential causes and viable solutions to be applied in future trials.
journal_name
Schizophr Bulljournal_title
Schizophrenia bulletinauthors
Kemp AS,Schooler NR,Kalali AH,Alphs L,Anand R,Awad G,Davidson M,Dubé S,Ereshefsky L,Gharabawi G,Leon AC,Lepine JP,Potkin SG,Vermeulen Adoi
10.1093/schbul/sbn110subject
Has Abstractpub_date
2010-05-01 00:00:00pages
504-9issue
3eissn
0586-7614issn
1745-1701pii
sbn110journal_volume
36pub_type
杂志文章abstract::The objective of this study is to compare the effectiveness among sulpiride, risperidone, olanzapine, and haloperidol by evaluating the persistence of drug use. A retrospective cohort study was conducted by analyzing the National Health Insurance Research Database of Taiwan. Patients with schizophrenia aged 18-65 year...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbs002
更新日期:2013-05-01 00:00:00
abstract::Most research literature concerning pharmacological treatments reports results from controlled clinical trials, which provide data critical to assess the efficacy of new treatments in research populations. Fewer studies examine how treatments are adopted in everyday practice settings, where comorbid disorders and envi...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/oxfordjournals.schbul.a006924
更新日期:2002-01-01 00:00:00
abstract::There is some evidence that schizotypal traits are related to a genetic or familial liability to develop schizophrenia. However, it is unclear whether the number of schizotypal traits is elevated in parents of schizophrenia patients compared with controls. This study used the Schizotypal Personality Questionnaire to i...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/oxfordjournals.schbul.a007131
更新日期:2004-01-01 00:00:00
abstract::Advances in psychopharmacology have produced medications with substantial efficacy in the treatment of positive and negative symptoms of schizophrenia and the prevention of relapse or symptom exacerbation after an acute episode. In the clinical setting, the individual patient's acceptance or rejection of prescribed ph...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章,评审
doi:10.1093/schbul/23.4.637
更新日期:1997-01-01 00:00:00
abstract::Self-experience anomalies are elementary features of schizophrenic pathology. Such deficits can have a profound impact on self-other relationship, but how they are related through aberrant brain function remains poorly understood. In this functional magnetic resonance imaging (fMRI) study, we provide new evidence for ...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbt153
更新日期:2014-09-01 00:00:00
abstract:Objective:A proinflammatory imbalance in the tumor necrosis factor (TNF) system may contribute to the pathogenesis of schizophrenia (SCZ) and bipolar disorders (BDs) and related comorbidities. We investigated the relative distribution of TNF-related molecules in blood and dorsolateral prefrontal cortex (DLPFC) in these...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbw183
更新日期:2017-07-01 00:00:00
abstract::Little is known about the neurobiological factors that determine functional outcome in people at high risk for psychosis. We use multimodal neuroimaging to investigate whether cortical responses during a cognitive task and thalamic glutamate levels were associated with subsequent functional outcome. Sixty subjects par...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbu115
更新日期:2015-03-01 00:00:00
abstract:OBJECTIVE:Embodied emotions arise from interoceptive and somatosensory processes, and are essential to the development of a stable sense of self. Emotional embodiment is therefore inherently interwoven with our sense of bodily self-awareness, and allows us to navigate complex social situations. Given that the core feat...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sby179
更新日期:2019-09-11 00:00:00
abstract:BACKGROUND:Patients with deficit schizophrenia differ from nondeficit patients with schizophrenia relative to several neurobiological correlates and relative to the risk factors of family history and season of birth. Exposure to human herpesviruses is a possible risk factor for schizophrenia. We hypothesized that there...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbi054
更新日期:2006-04-01 00:00:00
abstract:BACKGROUND:Emotion dysregulation is crucial to both poor social functioning and psychotic symptom formation in patients with schizophrenia. The efficient use of emotion regulation strategies, such as cognitive reappraisal, has been less frequently observed in the early phases of psychotic disorder. It is unknown whethe...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbaa080
更新日期:2021-01-23 00:00:00
abstract::A series of human and animal investigations has suggested that altered expression and function of the alpha7-nicotinic cholinergic receptor may be responsible for the auditory sensory gating deficit characterized in schizophrenia patients and their relatives as diminished suppression of an auditory-evoked response (P5...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章,评审
doi:10.1093/oxfordjournals.schbul.a033320
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND:Deficits in emotion processing are thought to underlie the key negative symptoms flat affect and anhedonia observed in psychotic disorders. This study investigated emotional experience and social behavior in the realm of daily life in a sample of patients with schizophrenia and schizoaffective disorder, stra...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbr137
更新日期:2013-01-01 00:00:00
abstract:OBJECTIVE:Stressful life events have been implicated in the onset of psychotic disorders, but there are few robust studies. We sought to examine the nature and magnitude of associations between adult life events and difficulties and first-episode psychoses, particularly focusing on contextual characteristics, including...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbaa005
更新日期:2020-07-08 00:00:00
abstract::The evidence suggesting that genetic factors are involved in the etiology of schizophrenia is reviewed. Despite methodological and other difficulties, independent lines of research--family, twin, and adoption studies--point in a common direction: Persons genetically at risk for schizophrenia are more likely to become ...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章,评审
doi:10.1093/schbul/6.3.404
更新日期:1980-01-01 00:00:00
abstract::The question of whether schizophrenia is associated with structural or functional abnormalities of the nervous system, or both, has become the principal focus of biological studies of schizophrenia. Computed tomography studies have revealed ventricular enlargement and cortical atrophy in a subgroup of schizophrenic pa...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/13.1.77
更新日期:1987-01-01 00:00:00
abstract::This article combines a review and meta-analysis of research on IQ in schizophrenia, with emphasis on areas of convergence in the findings, as well as questions that remain to be answered. Taken together, the findings suggest that early-onset and adult-onset schizophrenia are associated with intellectual deficits acro...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章,评审
doi:10.1093/schbul/10.3.430
更新日期:1984-01-01 00:00:00
abstract::The role of negative cognition and effect in maintaining psychotic symptoms is increasingly recognized but has yet to be substantiated though longitudinal analysis. Based on an a priori theoretical model, we hypothesized that negative cognition and depressed mood play a direct causal role in maintaining paranoia in pe...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbr019
更新日期:2012-09-01 00:00:00
abstract::Mobile assessment techniques have been used for nearly 3 decades in mental health research, including in investigations of individuals with schizophrenia and other severe disorders. This article reviews the benefits of these data collection strategies relative to traditional self-report or clinician-administered measu...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章,评审
doi:10.1093/schbul/sbr186
更新日期:2012-05-01 00:00:00
abstract::A greater understanding of the links between cognitive and social functioning changes is needed to refine cognitive treatments for schizophrenia. To date, studies have been cross-sectional, and few have investigated the impact of cognitive change. This single-blind randomized controlled trial explored the links betwee...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章,随机对照试验
doi:10.1093/schbul/sbl019
更新日期:2006-10-01 00:00:00
abstract::It is increasingly evident that the brain is not truly an immune privileged site and that cells of the central nervous system are sensitive to the inflammation generated when the brain is fighting off infection. Among the many microorganisms that have access to the brain, the apicomplexan protozoan Toxoplasma gondii h...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章,评审
doi:10.1093/schbul/sby082
更新日期:2018-08-20 00:00:00
abstract::The author reviews a number of studies which have shown that the overall mortality among patients with schizophrenia is about twice that in the general population. The highest excess mortality is found in suicide and violent death, but there seems to be an increased mortality also in cardiovascular disorders. Whether ...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/15.1.81
更新日期:1989-01-01 00:00:00
abstract:BACKGROUND:The clinical high-risk state for psychosis (HRP) is associated with an enhanced probability of developing a psychotic episode over a relatively short period of time. However, the extent to which different diagnostic types of illness develop remains unclear. METHODS:A systematic review was performed to ident...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章,meta分析,评审
doi:10.1093/schbul/sbs060
更新日期:2013-07-01 00:00:00
abstract::Abnormal reinforcement learning and representations of reward value are present in schizophrenia, and these impairments can manifest as deficits in risk/reward decision making. These abnormalities may be due in part to dopaminergic dysfunction within cortico-limbic-striatal circuitry. Evidence from studies with labora...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbu165
更新日期:2015-01-01 00:00:00
abstract::Schizotypal disorder is characterized by odd behavior and attenuated forms of schizophrenic features without the manifestation of overt and sustained psychoses. Past studies suggest that schizotypal disorder shares biological and psychological commonalties with schizophrenia. Structural magnetic resonance imaging (MRI...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbz051
更新日期:2020-02-26 00:00:00
abstract::The role of gender in schizophrenia is explored, and literature on gender and schizophrenia is critically reviewed. The importance of investigating gender differences in schizophrenia is underscored by the lack of sufficient research in this area to date and the comparative neglect of sociocultural issues during the "...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章,评审
doi:10.1093/oxfordjournals.schbul.a006944
更新日期:2002-01-01 00:00:00
abstract::The prodrome of psychosis has become a target for early identification and for treatments that address both symptoms and risk for future psychosis. Interest and activity in this realm is now worldwide. Clinical trials with rigorous methodology have only just begun, making treatment guidelines premature. Despite the sp...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章,多中心研究
doi:10.1093/schbul/sbm025
更新日期:2007-05-01 00:00:00
abstract::Thirty psychiatric inpatients each rated their relationship with their auditory hallucination using the Structural Analysis of Social Behavior questionnaires which assess partnerships in terms of interpersonal focus, love-hate, and enmeshment-differentiation. Results showed that all subjects had integrated, interperso...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/15.2.291
更新日期:1989-01-01 00:00:00
abstract::Many previous observers have reported some qualitative similarities between the normal mental state of dreaming and the abnormal mental state of psychosis. Recent psychological, tomographic, electrophysiological, and neurochemical data appear to confirm the functional similarities between these 2 states. In this study...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbm116
更新日期:2008-05-01 00:00:00
abstract::Changed synapse density has been suggested to be involved in the altered brain connectivity underlying schizophrenia (SCZ) pathology. However, postmortem studies addressing this topic are heterogeneous and it is not known whether changes are restricted to specific brain regions. Using meta-analysis, we systematically ...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sbz060
更新日期:2020-02-26 00:00:00
abstract::Genetic variants conferring risk for schizophrenia (SCZ) have been extensively studied, but the role of posttranscriptional mechanisms in SCZ is not well studied. Here we performed the first genome-wide microRNA (miRNA) expression profiling in serum-derived exosome from 49 first-episode, drug-free SCZ patients and 46 ...
journal_title:Schizophrenia bulletin
pub_type: 杂志文章
doi:10.1093/schbul/sby191
更新日期:2019-10-24 00:00:00