ANDREW LEON

..The applicability of mixed-effects models and the cure model to challenges in the study of onset of action is described...

..The simulations found that estimates were adversely affected by underrepresentation when there was lower ICC among repeated doses and among repeated outcomes...

..The present study examines the hypothesis that the three antiepileptics approved for bipolar disorder (carbamazepine, lamotrigine, and valproate) are associated with an elevated risk of suicide attempts and suicides...

..Ultimately, a DSMB's responsibilities are broader than that of the trial being monitored. It will protect potential study participants and eventually could affect patients seeking clinical treatment for the disorder being studied...

..NI hypothesis testing, on the other hand, requires an a priori NI margin and evidence of trial assay sensitivity. Either design demands unusually large samples, which could render such trials infeasible...

..The approach is illustrated in an evaluation of the effectiveness of somatic treatments for major depression in a longitudinal, observational study of affective disorders...

..Fundamental goals of RCT design are described. Strategies in design and analysis that contribute to the goals of an RCT and thereby enhance the likelihood of signal detection are considered...

..This approach is a useful strategy for observational studies of treatment effectiveness. It is capable of adjusting for selection bias, incorporating multiple observations per subject, and comparing effectiveness of ordinal doses...

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..Analyses of data from a randomized controlled clinical trial of treatments for mania in bipolar disorder are used to illustrate the application of the multiplicity adjustments...

..In addition, type I error rate and statistical power are examined. The approach is illustrated by applying it to a longitudinal, observational study of maintenance treatment of major depression...

..The objective of this article is to consider strategies that overcome the problems of unreliability and multiplicity...

..50; whereas the James procedure provides more statistical power with higher rho, the common correlation among the multiple outcomes. A study of gender differences in New York City homicides is used to illustrate the approaches...

..To determine the proportion of youth suicides in New York City from 1999 to 2002 in which antidepressants were detected at autopsy...

..Although likelihood-based statistical models such as mixed-effects models can accommodate incomplete data, the assumption of ignorable attrition is usually required for valid inferences...

..Nearly all suicidality in those trials was nonfatal suicide attempts and ideation. Here, we consider whether antidepressants are linked with adult suicide deaths...

..This information can be used to eliminate some of the very obstacles that lead to attrition, and can be incorporated in data analyses to reduce bias, but it will not eliminate all attrition bias...

..Here, a simple strategy is described that adjusts alpha for multiple primary efficacy measures, yet maintains statistical power for each test...

..The evolution of trial design and analysis during the lifespan of psychopharmacology is examined...

..As a result, trials with active comparators are more costly, require longer recruitment duration, and expose more participants to the risks of an experiment than do trials in which the only comparator is placebo...

..Evaluations presented here examine acute and maintenance antidepressant effectiveness and demonstrate effectiveness of the higher categorical doses...

..The goal of this study was to characterize primary care patients with false positive results on screens for mental disorders...

..The objective of this study was to examine the association of antidepressants with suicide attempts and with suicide deaths...

..Investigators should be forthright in stating these objectives of a pilot study. Grant reviewers and other stakeholders should expect no more...

..equivalence trial), and others are somewhat more discretionary (e.g., assessment tools, statistical procedures). Issues in the design and analysis of clinical trials comparing dual- and single-action antidepressants are discussed...

..When resources are abundant, the 2 × 2 design is the preferable approach for identifying personalized interventions because it directly tests the differential treatment effect, but its demand on research funds is extraordinary...

..CX516 was not effective for cognition or for symptoms of schizophrenia when added to clozapine, olanzapine, or risperidone...

..Symptom severity levels fluctuate, often within the same patient over time. Bipolar I disorder is expressed as a dimensional illness featuring the full range (spectrum) of affective symptom severity and polarity...

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..Longitudinally, BP-II is expressed as a dimensional illness involving the full severity range of depressive and hypomanic symptoms. Hypomania of long or short duration in BP-II seems to be part of the same disease process...

..e., general outpatient vs. methadone maintenance)...

..Both bipolar disorder type I and type II are characterized by frequent affective episode relapse and/or recurrence. An increasingly important goal of therapy is reducing chronicity by preventing or delaying additional episodes...

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..These results suggest a complex role of drugs in firearm-related deaths...

..We examined the frequency and severity of residual depressive symptoms in 2 studies comparing the selective serotonin reuptake inhibitor (SSRI) fluoxetine with the norepinephrine reuptake inhibitor (NRI) reboxetine...

..To compare the risk for cardiovascular mortality between bipolar I and bipolar II subtypes and determine correlates of cardiovascular mortality. Bipolar disorder conveys an increased risk of cardiovascular mortality...

..We examined postmortem evidence of antidepressant, analgesic, and anxiolytic-hypnotic drugs in suicide victims aged 65 years and older...

..Recent data indicate that lithium use for bipolar disorder has declined over the last decade and that lithium largely has been replaced with alternate, commercially promoted medications that may or may not result in better outcomes...

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..We hypothesized that patient preference at baseline would interact with treatment group to differentially affect treatment outcome...

..Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression (MD) with psychotic features...

..Previous studies have found that few chronically depressed patients remit with antidepressant medications alone...

..Recommendations at the design stage of a cluster-RCT are discussed...

..To determine whether an educational intervention would improve depression assessment and appropriate referral. Secondary analyses tested whether referral led to depression improvement...

..The results lend empirical support for the validity and reliability of this set of facial expressions as determined by accurate identification of expressions and high intra-participant agreement across two testing sessions, respectively...

..In 2004, the American Psychiatric Association's Committee on Research on Psychiatric Treatments appointed a subcommittee to investigate the status of empirical evidence with regard to psychodynamic psychotherapy...

..No data underlie this recommendation. This exploratory study assessed the moderating effect of personality disorder on psychodynamic and non-psychodynamic psychotherapy outcome...

..To the authors' knowledge, this is the first efficacy randomized controlled clinical trial of panic-focused psychodynamic psychotherapy, a manualized psychoanalytical psychotherapy for patients with DSM-IV panic disorder...

..This is illustrated using data from the Prevention Of Suicide in Primary care Elderly: Collaborative Trial (PROSPECT) study...

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..Among persons who died by fall from height, those 65 or older were more likely than others to have fallen from buildings where they lived...

..This observational study examined the effectiveness of somatic antidepressant treatments as administered in the community...

..Evidence of psychosocial disability in bipolar disorder is based primarily on bipolar I disorder (BP-I) and does not relate disability to affective symptom severity and polarity or to bipolar II disorder (BP-II)...

..The authors assessed the suicide rates of New York City police officers during a recent period...

..And we review studies that have identified 'core' symptoms of depression and compare these findings to the magnitude of individual symptom change we found in five studies of selective serotonergic or nonadrenergic antidepressants...

..A simulation study confirmed that theoretical power estimates based on the derived formulae are nearly identical to empirical estimates...

..limited symptom; spontaneous vs. situational) and between these subtypes, panic disorder subtypes, and other characteristics of panic disorder, especially agoraphobia...

..Using data from a longitudinal study of the mood disorders, the investigators address the phenomenon of unipolar mania...

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..Much remains unknown about the phenomenology of bipolar I disorder...

..The economic and public health benefits both point toward the value of such an intervention for disability claimants...

..These analyses were conducted to describe the course of illness among patients with major affective disorders who commit suicide...

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..quot; This criterion is problematic because different observers and constituencies often have different opinions about what types of change are clinically important and how much change is significant...

..This study examined psychosocial functioning as a predictor of recovery from episodes of unipolar major depression...

..Disinvestment in social and economic resources in unequal neighborhoods may explain this association. Public health interventions related to overdose risk should pay particular attention to highly unequal neighborhoods...

..To our knowledge, no prospective study has, as yet, described the course of this phenomenon beyond 5 years...

..Because treatment-seeking behavior is known to be associated with a worse prognosis, 23 weeks probably represents a lower-limit approximation of the median duration of an untreated depressive episode...

..Studies on the course of major depressive disorder (MDD) among elderly persons are limited to short periods of follow-up, seldom provide comparisons with younger cohorts, and raise other methodological concerns...

..In patients who have recovered from an episode of major depression, the presence of psychosocial impairment may help identify who is at increased risk of recurrence...

..The goal of this study was to develop and validate a brief instrument to screen for bipolar disorder in patients actively ill with major depression...

..This study describes recurrence of major depression despite maintenance pharmacotherapy, termed tachyphylaxis...

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..CONCLUSIONS: These data suggest that interventions to prevent accidental overdose mortality should address the use of drugs such as heroin, cocaine and alcohol in combination...

..Despite efforts devoted to areas, no study is without missing data. Once the study is completed, it is essential to assess the pattern of missing data and apply the appropriate statistical analysis...

..Its use could preclude the need for both endpoint and completer analyses. The performance of the proposed methodology will be evaluated and compared to standard procedures in a Simulation Study (Aim 4). ..

..In summary, this interdisciplinary project will inform methodologists about the proposed data analytic strategy and inform clinicians about effectiveness of treatments for PD, BDD, and bipolar depression. ..