Generalizability of pharmacologic and psychotherapy trial results for late-life unipolar depression.

OBJECTIVES: Despite evidence of low representativeness of clinical trial results for depression in adults, the generalizability of clinical trial results for late-life depression is unknown. This study sought to quantify the representativeness of pharmacologic and psychotherapy clinical trial results for late-life unipolar depression. METHOD: Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a nationally representative sample of 34,653 adults from the United States population. To assess the generalizability of clinical trial results for late-life depression, we applied a standard set of eligibility criteria representative of pharmacologic and psychotherapy clinical trials to all individuals aged 65 years and older in NESARC with a DSM-IV diagnosis of MDE and no lifetime history of mania/hypomania (n = 273) and in a subsample of individuals seeking help for depression (n = 78). RESULTS: More than four of ten respondents and about two of ten respondents would have been excluded by at least one exclusion criterion in a typical pharmacologic and psychotherapy efficacy trial, respectively. Similar results (i.e.41.1% and 25.9%, respectively) were found in the subsample of individuals seeking help for depression. Excess percentage of exclusion in typical pharmacologic studies was accounted for by the criterion "significant medical condition". We also found that populations typically included in pharmacologic and psychotherapy clinical trials for late-life unipolar depression may substantially differ. CONCLUSION: Psychotherapy trial results may be representative of most patients with late-life unipolar depression in routine clinical practice. By contrast, pharmacologic clinical trials may not be readily generalizable to community samples.

Are participants in pharmacological and psychotherapy treatment trials for social anxiety disorder representative of patients in real-life settings?

BACKGROUND: The present study sought to quantify the generalizability of clinical trial results in individuals with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of social anxiety disorder (SAD) to a large representative community sample. METHODS: Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions, a large nationally representative sample of 34,653 adults from the US population. We applied a standard set of exclusion criteria representative of pharmacological and psychotherapy clinical trials to all adults with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of SAD (n = 965) in the past 12 months and then to a subsample of participants seeking treatment (n = 363). Our aim was to assess how many participants with SAD would fulfill typical eligibility criteria. RESULTS: We found that more than 7 of 10 respondents from the overall SAD sample in a typical pharmacological efficacy trial and more than 6 of 10 participants in a typical psychotherapy efficacy trial would have been excluded by at least 1 criterion. In addition, more than 8 of 10 respondents seeking treatment for SAD would have been excluded from participation in a typical pharmacological or psychotherapy efficacy trial. Having a current major depression explained a large proportion of ineligibility. CONCLUSIONS: Clinical trials should carefully consider the impact of exclusion criteria on the generalizability of their results and explain the rationale for their use. For SAD treatment trials to adequately inform clinical practice, the eligibility rate must be increased through a general relaxation of overly stringent eligibility criteria.

Generalizability of clinical trial results for generalized anxiety disorder to community samples.

BACKGROUND: There has been little research on the generalizability of clinical trials for generalized anxiety disorder (GAD). The present study examines the generalizability of pharmacological and psychotherapy clinical trials' results of individuals with DSM-IV GAD to a large community sample. METHODS: Data were drawn from the National Epidemiological Survey on Alcohol and Related Conditions (NESARC), a large national representative face-to-face sample of 43,093 adults of the United States population. We applied a standard set of eligibility criteria representative of GAD pharmacological and psychotherapy clinical trials to all adults with past 12 months GAD (n = 894), and to a subgroup of participants seeking treatment (n = 329). Our aim was to assess how many participants with GAD would fulfil typical eligibility criteria. RESULTS: We found that more than seven out of 10 participants with GAD were excluded by at least one criterion. In the subgroup of GAD participants who sought treatment, the exclusion rate by at least one criterion raised to more than eight out of 10 participants with GAD. For the overall sample and the treatment-seeking subsample, having a current depression was the criterion excluding the highest percentage of individuals. Having a lifetime history of bipolar disorder, a current significant medical condition, a current diagnosis of alcohol abuse or dependence, and a social or specific phobia also excluded a substantial proportion of individuals in both samples. CONCLUSIONS: Clinical trials exclude a majority of adults with GAD. Clinical trials should carefully consider the impact of eligibility criteria on the generalizability of their results.

Long-term care utilization within older adults with schizophrenia: Associated factors in a multicenter study.

OBJECTIVE: Data are scarce regarding the clinical factors associated with utilization of long-term care facilities among older adults with schizophrenia. In this multicenter study, we sought to examine potential clinical differences between older adults with schizophrenia who are living in a long-term care facility and their community-dwelling counterparts. METHOD: We used data from the French Cohort of individuals with Schizophrenia Aged 55-years or more (CSA) study, a large multicenter sample of older adults with schizophrenia (N = 353). RESULTS: The prevalence of long-term care utilization was 35.1% of older patients with schizophrenia. Living in a long term care facility was significantly and independently associated with higher level of depression (Adjusted odds ratio (AOR) [95%CI]=1.97 [1.06-3.64]), lower cognitive (AOR [95%CI]=0.94 [0.88-0.99]) and global functioning (AOR [95%CI]=0.97 [0.95-0.99]), greater lifetime number of hospitalizations in a psychiatric department (AOR [95%CI]=2.30 [1.18-4.50]), not having consulted a general practitioner in the past year (AOR [95%CI]=0.28 [0.0.14-0.56]), urbanicity (AOR [95%CI]=2.81 [1.37-5.80]), and older age (AOR [95%CI]=1.08 [1.03-1.13]). DISCUSSION: Older patients with schizophrenia who live in long-term care facilities appear to belong to a distinct group, marked by a more severe course of illness with higher level of depression and more severe cognitive deficits than older patients with schizophrenia living in other settings. Our study highlights the need of early assessment and management of depression and cognitive deficits in this population and the importance of monitoring closely this vulnerable population.

Management of panic disorder in the elderly.

Panic disorder in the elderly is an understudied disorder, despite being associated with substantial functional impairment, a diminished quality of life and an increased suicide risk in this population. This disorder is likely to be underdiagnosed and sometimes inadequately treated due to the absence of national and international guidelines for this vulnerable population. Few therapeutic trials have specifically focused on the efficacy and tolerability of pharmacological and psychotherapy treatments for panic disorder in the elderly and current approaches to detect and manage this disorder are mainly based on expert opinions or extrapolation from data available on younger adults. This report aims to provide a summary of current knowledge on pharmacological and psychotherapeutic treatments for panic disorder in the elderly and to propose a medical treatment algorithm, which should be viewed as a tool that may contribute to the choice of treatment, especially for treatment-resistant older patients with panic disorder. The main results here are the emphasis on antidepressant treatment, such as selective serotonin reuptake inhibitor (SSRI), restricted benzodiazepine usage, awareness of drug interactions and the importance of psychotherapy such as cognitive behavioural therapy (CBT).

[Management of panic disorder in the elderly]. / Prise en charge du trouble panique chez le sujet âgé.

Panic disorder in the elderly is an understudied disorder, despite being associated with substantial functional impairment, diminished quality of life and increased suicide risk in this population. This disorder is likely to be underdiagnosed and sometimes inadequately treated in the absence of national and international guidelines for this vulnerable population. Few therapeutic trials have specifically focused on the efficacy and tolerability of pharmacologic and psychotherapy treatments for panic disorder in the elderly, and current approaches to detect and manage this disorder are mainly based on experts' opinion or extrapolation from data available in younger adults. This report aims to provide a summary of current knowledge on pharmacologic and psychotherapeutic treatments for panic disorder in the elderly, and to propose a medical treatment algorithm, which should be viewed as a tool that may contribute to the choice of treatment, especially for treatment-resistant older patients with panic disorder. The main results here are the emphasis on antidepressant treatment, like selective serotonin reuptake inhibitor (SSRI), restricted benzodiazepine usage, take care of drug interactions, and importance of psychotherapy like cognitive behavioral therapy (CBT).

Effects of depression and cognitive impairment on quality of life in older adults with schizophrenia spectrum disorder: Results from a multicenter study.

BACKGROUND: Little is known about the respective effects of depression and cognitive impairment on quality of life among older adults with schizophrenia spectrum disorder. METHODS: We used data from the Cohort of individuals with Schizophrenia Aged 55-years or more (CSA) study, a large multicenter sample of older adults with schizophrenia or schizoaffective disorder (N = 353). Quality of life (QoL), depression and cognitive impairment were assessed using the Quality of Life Scale (QLS), the Center of Epidemiologic Studies Depression scale and the Mini-Mental State Examination, respectively. We used structural equation modeling to examine the shared and specific effects of depression and cognitive impairment on QoL, while adjusting for sociodemographic characteristics, general medical conditions, psychotropic medications and the duration of the disorder. RESULTS: Depression and cognitive impairment were positively associated (r = 0.24, p < 0.01) and both independently and negatively impacted on QoL (standardized ß = -0.41 and ß = -0.32, both p < 0.01) and on each QLS quality-of-life domains, except for depression on instrumental role and cognitive impairment on interpersonal relations in the sensitivity analyses excluding respondents with any missing data. Effects of depression and cognitive impairment on QoL were not due to specific depressive symptoms or specific cognitive domains, but rather mediated through two broad dimensions representing the shared effects across all depressive symptoms and all cognitive deficits, respectively. LIMITATIONS: Because of the cross-sectional design of this study, measures of association do not imply causal associations. CONCLUSIONS: Mechanisms underlying these two broad dimensions should be considered as important potential targets to improve quality of life of this vulnerable population.

Examining sex differences in DSM-IV-TR narcissistic personality disorder symptom expression using Item Response Theory (IRT).

The limited published literature on the subject suggests that there may be differences in how females and males experience narcissistic personality disorder (NPD) symptoms. The aim of this study was to use methods based on item response theory to examine whether, when equating for levels of NPD symptom severity, there are sex differences in the likelihood of reporting DSM-IV-TR NPD symptoms. We conducted these analyses using a large, nationally representative sample from the USA (n=34,653), the second wave of the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). There were statistically and clinically significant sex differences for 2 out of the 9 DSM-IV-TR NPD symptoms. We found that males were more likely to endorse the item 'lack of empathy' at lower levels of narcissistic personality disorder severity than females. The item 'being envious' was a better indicator of NPD severity in males than in females. There were no clinically significant sex differences on the remaining NPD symptoms. Overall, our findings indicate substantial sex differences in narcissistic personality disorder symptom expression. Although our results may reflect sex-bias in diagnostic criteria, they are consistent with recent views suggesting that narcissistic personality disorder may be underpinned by shared and sex-specific mechanisms.

Generalizability of clinical trial results for bipolar disorder to community samples: findings from the National Epidemiologic Survey on Alcohol and Related Conditions.

BACKGROUND: Research on the generalizability of clinical trial results for bipolar disorder is limited. The present post hoc study sought to quantify the generalizability of clinical trial results in individuals with DSM-IV bipolar disorder to a large representative community sample. METHOD: Data were derived from the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a large, nationally representative sample of 43,093 adults from the United States population. We applied a standard set of eligibility criteria representative of clinical trials to all adults with DSM-IV bipolar depression (n = 785) or mania (n = 724) in the past 12 months and then to a subsample of participants seeking treatment for bipolar depression (n = 276). Our aim was to determine the proportion of participants with bipolar depression or acute mania who would have been excluded from a clinical trial by typical eligibility criteria. RESULTS: We found that more than 5 of 10 participants with bipolar depression (58.17%) or mania (55.75%) would have been excluded by at least 1 eligibility criterion. In the subgroup of participants with bipolar depression who sought treatment, the exclusion rate by at least 1 criterion was higher (63.87%). Having a significant risk of suicide was the criterion excluding the highest percentage of participants in the bipolar depression samples, while having a current DSM-IV diagnosis of alcohol abuse or dependence was the one leading to the greatest exclusion rate in clinical trials for participants with acute mania. Exclusion rates were higher for participants with bipolar I depression compared with those with bipolar II depression. CONCLUSIONS: Traditional clinical trials tend to exclude a majority of individuals with bipolar disorder. Clinical trials should carefully consider the impact of eligibility criteria on the generalizability of their results and explain the rationale for their use. Future trials should weigh the trade-offs between internal validity and the representativeness of the study.

Gender effects in bullying: results from a national sample.

This study presents gender effects in sociodemographics and psychiatric correlates of bullying in the United States. Data were drawn from the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a nationally representative sample of U.S. adults. Face-to-face interviews of more than 43,000 adults were conducted during the 2001-2002 period. The present study compared 2460 respondents who ever bullied with 39,501 respondents who did not, stratified by gender. The prevalence of this behavior in the U.S. was significantly higher in men (8.5%) than in women (4.2%). Multivariate logistic regression analyses indicated strong associations in both genders with numerous psychiatric and addictive disorders with significant gender effects. Following adjustments for sociodemographic characteristics and other antisocial behaviors, women who ever bullied were significantly more likely to have any lifetime externalizing, including conduct disorder, as well as any lifetime internalizing spectrum disorder compared to men with such behavior. Bullying in women may be a symptom of a broader syndrome than in men, including more prevalent impairment of impulse control and more frequent affective disorders.

Estimated cost of a factitious disorder with 6-year follow-up.

Long-term follow up is rarely described for patients with Factitious Disorder, mainly because of the lack of access to patient's confidential information. In addition, the financial burden of multiple uses of health care system has not been examined so far. We report a 6-year follow-up for a patient with Factitious Disorder who first reported neurological then psychiatric symptoms, and investigate the cost of his detected hospitalizations.

Radiofrequency ablation of atrial fibrillation: the first 100 cases in Lyon.

The aim of the study was to estimate the efficacy and complications of the first ablations of atrial fibrillation (AF) performed in a single teaching institution. The first 100 consecutive patients with symptomatic paroxysmal, persistent or permanent AF treated by application of radiofrequency in the left atrium, were included. In the patients with paroxysmal AF, success was judged as complete in 21 out of the 35 (60%). The benefit was lower in patients with persistent arrhythmia (19 out of 42, 45%). In the 23 patients with permanent AF, there were 16 failures (69%) with recurrence of AF in 10 patients the day after the procedure. There were 13 patients (13%) with minor complications.