Abstract：
:Early score fluctuation in double-blind, placebo-controlled studies may affect the reliability of the baseline measurement and adversely affect the eventual study outcome. We examined the effect of early score fluctuation during a 2-week double-blind placebo lead-in period in a phase II, double-blind, placebo-controlled trial of adjunctive s-adenosyl methionine (MSI-195) in MDD subjects who had had an inadequate response to ongoing antidepressant treatment. The overall study failed to meet its specified endpoints. We examined the score trajectories of all placebo-assigned subjects during the double-blind placebo lead-in period and subsequent 6-week treatment period. Placebo-assigned subjects with ≥20% HamD17 or MADRS score fluctuations (improvement or worsening) during the double-blind placebo lead-in period (prior to randomization) had significantly higher rates of placebo response and remission at week 8 compared to subjects with <20% response. A post-hoc analysis of evaluable subjects taken from the ITT population that excluded subjects with ≥20% early score response yielded higher effect sizes for both the HamD17 and MADRS sub-groups and statistical significance for MSI-195 over placebo in the MADRS sub-group (p = 0.012) with an effect size of 0.404. A reliable baseline measure is an asset for signal detection. These post-hoc findings suggest that study designs that anticipate and attempt to manage early response prior to randomization may yield more meaningful outcome data for trials of MDD and possibly other disorders as well.
journal_name
J Psychiatr Resjournal_title
Journal of psychiatric researchauthors
Targum SD,Cameron BR,Ferreira L,MacDonald IDdoi
10.1016/j.jpsychires.2019.11.014subject
Has Abstractpub_date
2020-02-01 00:00:00pages
118-125eissn
0022-3956issn
1879-1379pii
S0022-3956(19)31095-7journal_volume
121pub_type
杂志文章abstract：BACKGROUND:While most of the second generation antipsychotic agents are associated with abnormal glucose metabolism, previous studies have shown that risperidone has relatively little effect upon blood glucose levels. This study aimed to explore the effect of risperidone on the glucose-regulating mechanism of patients ...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2008.03.004
更新日期：2008-12-01 00:00:00
abstract：:Appetite and satiety responses in a test meal paradigm were studied in six anorexia nervosa patients (four had bingeing and purging behaviors) and in nine normal control women. The anorexic patients were distinguished from normal controls by the amounts of food taken and by the pattern of the hunger and fullness respo...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/0022-3956(85)90029-9
更新日期：1985-01-01 00:00:00
abstract：:The gut microbiome is emerging as an important factor in regulating mental health yet it remains unclear what the target should be for psychiatric treatment. We aimed to elucidate the complement of the gut-microbiome community for individuals with bipolar disorder relative to controls; and test for relationships with ...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2016.12.007
更新日期：2017-04-01 00:00:00
abstract：BACKGROUND:Previous studies indicate that negative symptoms reflect a separable domain of pathology from other symptoms of schizophrenia. However, it is currently unclear whether negative symptoms themselves are multi-faceted, and whether sub-groups of patients who display unique negative symptom profiles can be identi...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2013.01.015
更新日期：2013-06-01 00:00:00
abstract：:Oxidative DNA damage has been proposed as one of the causes of schizophrenia (SZ), and post mortem data indicate a dysregulation of apoptosis in SZ patients. To evaluate apoptosis in vivo we quantified the concentration of plasma cell-free DNA (cfDNA index, determined using fluorescence), the levels of 8-oxodG in cfDN...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2016.12.006
更新日期：2017-04-01 00:00:00
abstract：OBJECTIVE:Studies have documented the significant direct and indirect psychological, social, and economic consequences of the Coronavirus disease 2019 (COVID-19) in many countries but little is known on its impact in low- and middle-income countries (LMICs) already facing difficult living conditions and having vulnerab...
journal_title：Journal of psychiatric research
pub_type： 杂志文章,多中心研究
doi：10.1016/j.jpsychires.2020.09.031
更新日期：2021-01-01 00:00:00
abstract：:In a prospective study of a random sample of 1,007 young adults, we examined the association between migraine and psychiatric disorder, physical complaints, indicators of functional impairment, and use of mental health services. A history of migraine was associated with increased lifetime rates of major depression, an...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/0022-3956(93)90009-q
更新日期：1993-04-01 00:00:00
abstract：:Previous studies have reported abnormalities either in the cAMP-dependent endogenous phosphorylation or in the levels of Rap1 in platelets from bipolar patients. One limitation of these findings was that they come from different groups of patients in independent studies. To overcome this limitation, we designed the pr...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/s0022-3956(99)00047-3
更新日期：2000-03-01 00:00:00
abstract：BACKGROUND:Earlier age at onset of psychosis (AOP) has been associated with poor social adjustment and clinical outcome. Genetic and environmental factors such as obstetric complications, parental history of psychosis, advanced paternal age at time of birth, low birth weight and gestational age, and use of drugs have b...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2015.03.018
更新日期：2015-06-01 00:00:00
abstract：:Hoarding behaviors are positively associated with medical morbidity, however, current prevalence estimates and types of medical conditions associated with hoarding vary. This analysis aims to quantify the medical morbidity of hoarding disorder (HD). Cross-sectional data were collected online using the Brain Health Reg...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2020.12.032
更新日期：2020-12-15 00:00:00
abstract：:Molecular knowledge about schizophrenia--a psychotic, multifactorial mental disorder that affects about 1% of the population worldwide--is limited and no diagnostic biomarkers are available. The comparative proteome analysis of human brain tissue from patients with schizophrenia and healthy controls may supply useful ...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2010.03.003
更新日期：2010-10-01 00:00:00
abstract：:Diagnosing major depressive disorder (MDD) continues to be based on meeting phenomenological and descriptive criteria. As of yet, there is still no non-invasive, peripheral biomarker that would allow for a certain diagnosis of MDD. The objective of this paper is to use the receiver operating characteristic (ROC) analy...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2012.09.017
更新日期：2013-02-01 00:00:00
abstract：:Cannabis is commonly used recreationally for its euphoric and relaxing effects, while its medical use is permitted in several jurisdictions. With only low-quality evidence suggesting anxiolytic effects of cannabis and strong public sentiment surrounding such purported effects, the purpose of this study was to examine ...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2019.01.024
更新日期：2019-04-01 00:00:00
abstract：OBJECTIVES:Clinical research projects gather large amounts of data. Typically, information is captured on paper source documents for later transcription to an electronic format, where responses can be checked, and errors, omissions, and inconsistencies can be resolved. These steps contribute delays, cost, and complexit...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2006.07.015
更新日期：2007-11-01 00:00:00
abstract：BACKGROUND:Prior cross-sectional studies have suggested that being a late chronotype is associated with depression and depressive symptoms, but prospective data are lacking. METHODS:We examined the association between chronotype and incident depression (defined as self-reported physician/clinician-diagnosed depression...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2018.05.022
更新日期：2018-08-01 00:00:00
abstract：:The Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) formally introduced a dissociative subtype of posttraumatic stress disorder (PTSD). This study examined the proportion of U.S. veterans with DSM-5 PTSD that report dissociative symptoms; and compared veterans with PTSD with and without the ...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2015.04.017
更新日期：2015-07-01 00:00:00
abstract：:Efficacy trials with antidepressant drugs often fail to show significant treatment effect even though efficacious treatments are investigated. This failure can, amongst other factors, be attributed to the lack of sensitivity of the statistical method as well as of the endpoints to pharmacological activity. For regulat...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2007.11.009
更新日期：2008-10-01 00:00:00
abstract：:Elevated rates of cigarette smoking are observed prior to the onset of psychosis and remain stable early in the illness. Cannabis use frequently co-occurs with cigarette smoking and is independently associated with distinct clinical outcomes. However, past research has not controlled for cannabis use in cigarette smok...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2016.10.022
更新日期：2017-02-01 00:00:00
abstract：BACKGROUND:Since the onset, prevalence, and course of specific psychopathological features rarely have been analyzed simultaneously from the start of dissimilar psychotic illnesses, we compared symptom-clusters in first-episode DSM-IV affective and non-affective psychotic disorders. METHODS:Subjects (N=377) from the M...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2006.04.008
更新日期：2007-11-01 00:00:00
abstract：:Melatonin is a hormone that produces behavioral, pharmacological, and physiological effects through the activation of MT1 and MT2 melatonin receptors. Melatonin receptors participate in the modulation of the reinforcing effects of cocaine. Some studies report that dosing of melatonin decreases cocaine-induced locomoto...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2020.09.027
更新日期：2021-01-01 00:00:00
abstract：:Drop-out is a common phenomenon in clinical trials of drug treatments involving longitudinal assessments for a fixed duration of follow-up. For these trials intent-to-treat (IT) analysis is usually preferred because time effects are seen in practice. The IT analysis mandates that all subjects randomized to a treatment...
journal_title：Journal of psychiatric research
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1016/s0022-3956(98)00058-2
更新日期：1999-03-01 00:00:00
abstract：:Previous studies with 1.5 T or 3.0 T magnetic resonance imaging (MRI) have produced mixed results regarding the structural changes of the hippocampus in major depressive disorder (MDD). Subtle region-specific hippocampal tissue changes might be more sensitively detected by measuring the T2* relaxation time (T2*-RT) by...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2010.02.014
更新日期：2010-10-01 00:00:00
abstract：:The investigation of neural substrates of autism spectrum disorder using neuroimaging has been the focus of recent literature. In addition, machine-learning approaches have also been used to extract relevant information from neuroimaging data. There are only few studies directly exploring the inter-regional structural...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2012.11.017
更新日期：2013-04-01 00:00:00
abstract：:Reports have described how psychiatric patients respond to disasters. However, previous reports on the response depending on diagnostic categories have provided no clear consensus. Here we analyzed response to the Great East Japan Earthquake of March 11, 2011, among psychiatric patients in light of severity of pre-exi...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2013.06.006
更新日期：2013-10-01 00:00:00
abstract：:The typical reliance on self-report questionnaires in retrospective case-control studies of childhood abuse and psychotic disorders has been criticised, due to the potential for recall bias associated with, amongst other factors, cognitive impairments and detachment from reality, among individuals with psychosis. One ...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2020.02.002
更新日期：2020-04-01 00:00:00
abstract：:Lumbar puncture was performed on 12 healthy female volunteers at the L4-5 level. CSF concentrations of 5-HIAA, HVA and HMPG were included in turn as dependent variables in repeated analyses of covariance with age, height, tapping-time, atmospheric pressure and the distance on the spine in the lying position as regress...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/0022-3956(94)90041-8
更新日期：1994-11-01 00:00:00
abstract：OBJECTIVE:(a) To investigate the correlation between clinical symptoms and neurological soft signs in patients suffering from their first episode of schizophrenia and (b) to examine the relationship between soft signs and the reactivity of first episode treatment. METHODS:The trial included 92 male patients undergoing...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2005.03.008
更新日期：2006-03-01 00:00:00
abstract：BACKGROUND:Repeated exposure to the traumatic memory (RETM) is a common component of treatments for posttraumatic stress disorder (PTSD). This treatment is based on a fear extinction model; however, the degree to which this treatment actually engages and modifies neural networks mediating fear extinction is unknown. Th...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2013.09.013
更新日期：2014-01-01 00:00:00
abstract：:Anorexia nervosa (AN) is a severe mental disorder accompanied by extensive metabolic and endocrine abnormalities. It has been associated with hypercortisolism using short-term measurement methods such as 24 h-urine, saliva, and blood. The aim of this study was to examine whether the proposed hypercortisolism in acutel...
journal_title：Journal of psychiatric research
pub_type： 杂志文章
doi：10.1016/j.jpsychires.2017.11.010
更新日期：2018-03-01 00:00:00
abstract：:Serotonin modulates brain oscillatory activity, and serotonergic projections to the thalamus and cortex modulate the frequency of prefrontal rhythmic oscillations. Changes in serotonergic tone have been reported to shift oscillations between the combined delta-theta (2.5-8 Hz) and the alpha (8-12 Hz) frequency ranges....
journal_title：Journal of psychiatric research
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.jpsychires.2016.10.002
更新日期：2017-01-01 00:00:00
