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Biomedical subjects

W Vaughn McCall

Publications and source records attributed to W Vaughn McCall.

At least 19 recordsLinked to original sources

Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder.

BACKGROUND: Insomnia and major depressive disorder (MDD) can coexist. This study evaluated the effect of adding eszopiclone to fluoxetine. METHODS: Patients who met DSM-IV criteria for both MDD and insomnia (n = 545) received morning fluoxetine and were randomized to nightly eszopiclone 3 mg (ESZ+FLX) or placebo (PBO+FLX) for 8 weeks. Subjective sleep and daytime function were assessed weekly. Depression was assessed with the 17-item Hamilton Rating Scale for Depression (HAM-D-17) and the Clinical Global Impression Improvement (CGI-I) and Severity items (CGI-S). RESULTS: Patients in the ESZ+FLX group had significantly decreased sleep latency, wake time after sleep onset (WASO), increased total sleep time (TST), sleep quality, and depth of sleep at all double-blind time points (all p < .05). Eszopiclone co-therapy also resulted in: significantly greater changes in HAM-D-17 scores at Week 4 (p = .01) with progressive improvement at Week 8 (p = .002); significantly improved CGI-I and CGI-S scores at all time points beyond Week 1 (p < .05); and significantly more responders (59% vs. 48%; p = .009) and remitters (42% vs. 33%; p = .03) at Week 8. Treatment was well tolerated, with similar adverse event and dropout rates. CONCLUSIONS: In this study, eszopiclone/fluoxetine co-therapy was relatively well tolerated and associated with rapid, substantial, and sustained sleep improvement, a faster onset of antidepressant response on the basis of CGI, and a greater magnitude of the antidepressant effect.

Adult↗

Health-related quality of life following ECT in a large community sample.

BACKGROUND: While electroconvulsive therapy (ECT) is a potent antidepressant, little is known about its long-term effects on health-related quality of life (HRQOL). METHODS: Using a naturalistic, observational design, 283 depressed patients, who received ECT at 7 hospitals in the New York City area, were assessed for HRQOL with the Medical Outcomes Study Short Form - 36 (SF-36) at baseline, several days after ECT, and 24 weeks later. Depression severity was assessed with the Hamilton Rating Scale for Depression, and a neuropsychological battery was also administered. RESULTS: Baseline SF-36 scores were very low, indicating poor HRQOL. These scores were improved at postECT and at the 24-week follow-up. Unexpectedly, the degree of retrograde amnesia for autobiographical information was associated with better HRQOL in the immediate postECT period, but not at 24-week follow-up. In contrast, improvement in global cognitive status was associated with superior HRQOL at the 24-week time point. LIMITATIONS: This study was limited by the lack of a non-ECT comparison group, and the naturalistic design of treatment. CONCLUSIONS: ECT is associated with improved HRQOL in the short- and long-term, with the enhancements largely explained by improvements in depressive symptoms. The acute cognitive effects of ECT may also influence HRQOL assessment, and evaluations removed in time from the treatment may have greater validity.

Activities of Daily Living↗

Health-related quality of life and the practice of electroconvulsive therapy.

In the past several decades, health-related quality of life (HRQL) measures have become increasingly important as a type of patient-reported outcome documenting the subjective psychosocial burden associated with chronic illness. This article provides an introduction to HRQL, summarizes the measurement of HRQL in major depression and bipolar disorder, and reviews electroconvulsive therapy (ECT) studies that have measured HRQL. Health-related quality-of-life definitions and instruments vary widely but have nonetheless proven useful for evaluating the effects of disease and its treatment. Psychiatric disorders profoundly affect HRQL and, in many cases, exceed or contribute to the disease burden imposed by serious physical illness. An emerging literature demonstrates the importance of ECT in restoring function and HRQL in depressed patients. To keep pace as medicine is transformed along the dimensions outlined by the Institute of Medicine's Quality Chasm framework, ECT research must provide evidence supporting its safety and effectiveness and also that the treatment is patient-centered. A research agenda to demonstrate the subjective benefits of ECT must be mirrored by a practice of ECT that is increasingly customized to patient needs and values.

Antidepressive Agents↗

What predicts patients' expressed likelihood of choosing electroconvulsive therapy as a future treatment option?

OBJECTIVE: To examine the relationship between stated intention to choose electroconvulsive therapy (ECT) as a future treatment option and measures of function and quality of life, mood, and cognition in the month after this therapy. Understanding the factors influencing patient choice of ECT is a source of insight into the interplay between measures of response and perceived value of this treatment to patients, lending perspective to patient-centered quality improvement efforts. METHOD: In a prospective sample of 77 depressed patients given ECT, we surveyed recipients at 1 month about their expressed likelihood of choosing ECT given a future episode and examined predictors of their responses. RESULTS: Thirty-four subjects were classified as "likely" to choose a course of ECT, whereas 33 patients were "unlikely." A model including Hamilton baseline and change scores as well as baseline scores in instrumental activities of daily living significantly predicted likeliness after controlling for age and sex (R = 0.34, P < 0.0001). Other quality-of-life variables and measures of change in cognition were not significant in the model. CONCLUSIONS: In our sample, choosing ECT as a future treatment option was more likely for those who were more depressed before treatment, had more impaired instrumental activities at the outset of treatment, and experienced a more robust improvement in depressive symptoms. This variance was not explained by treatment-associated improvements in quality of life, function, or deficits in cognitive status.

Activities of Daily Living↗

Placebo effects in primary insomnia.

Placebo effects are commonly observed in insomnia clinical trials. With the advent of longer-term trials, such effects appear to be remarkably robust and durable. In this paper we review the classic factors that are believed to contribute to placebo effects and how these factors operate in insomnia randomized clinical trials. Beyond this we suggest that the episodic nature of insomnia may interact with patient preferences for intermittent dosing in such a way as to sustain placebo effects in the long term. An appreciation of the latter phenomenon may provide increased power to detect therapeutic outcomes and may be used to potentiate clinical gains.

Humans↗

A 2-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia.

STUDY OBJECTIVES: Evaluate the efficacy of eszopiclone in primary insomnia. DESIGN/SETTING: Randomized, double-blind, placebo-controlled multicenter in outpatient setting with weekly visits. PARTICIPANTS: Two-hundred thirty one men and women aged 65 to 85 years (mean age 72.3 years) with primary insomnia, as defined by the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition. INTERVENTIONS: Eszopiclone 1 mg (n = 72), eszopiclone 2 mg (n = 79), or placebo (n = 80) nightly for 2 weeks. MEASUREMENTS/RESULTS: Efficacy was assessed using an interactive voice response system. Following the predefined hierarchical testing strategy, the eszopiclone 2-mg group had a significantly shorter sleep latency compared with placebo over the double-blind period (P = .0034). The eszopiclone 2-mg group had significantly longer total sleep time (P = .0003) and eszopiclone 1-mg group had significantly shorter sleep latency (P < or = .012) compared with placebo. The eszopiclone 1-mg group was not significantly different from placebo on total sleep time or any other secondary efficacy endpoint. Secondary analyses indicated that the eszopiclone 2-mg group had significantly less wake after sleep onset; significantly fewer and shorter in duration daytime naps; and significantly higher ratings of sleep quality and depth, daytime alertness, and sense of physical well-being compared with placebo (P < .05). Eszopiclone was well tolerated. The most frequent treatment-related adverse event was unpleasant taste. CONCLUSION: Nightly treatment with eszopiclone 1 mg effectively induced sleep, while the 2-mg dose was effective in inducing and maintaining sleep. Eszopiclone was well tolerated in elderly patients with primary insomnia, and the sleep efficacy was accompanied by significantly less napping and significantly higher ratings of daytime alertness, sense of physical well-being, and several quality-of-life parameters at the higher dose.

Aged↗

Seizure length and clinical outcome in electroconvulsive therapy using methohexital or thiopental.

Seizure duration is an extensively studied and controversial indicator of treatment quality in electroconvulsive therapy. Previous research comparing the effect of the barbiturate anesthetics methohexital and thiopental on seizure duration has yielded conflicting results. A recent period of unavailability of methohexital in the United States allowed for retrospective comparison of seizure length as well as clinical improvement in treatment using each agent. Retrospective review was made of 837 treatments administered to 97 patients between January 2, 2002, and May 31, 2003, examining anesthetic, seizure duration, and Global Assessment of Functioning (GAF) scores of inpatients at hospital admission and discharge. Analysis of variance of treatments 2-5 showed no significant effect for anesthetic on seizure duration. Analysis on a treatment-by-treatment basis revealed a marginally significant trend toward shorter EEG seizures in the thiopental group at the second treatment (50.5 +/- 23.6 s vs. 61.1 +/- 27.9 s; P = 0.07) and fifth treatment (41.7 +/- 16.9 s vs. 51.8 +/- 24.0 s; P = 0.07). A difference approaching statistical significance revealed shorter convulsion length in the thiopental group at treatment 5 (29.0 +/- 12.3 s vs. 34.8 +/- 12.3 s; P = 0.07). Comparison of GAF score improvement at hospital discharge revealed no significant difference (GAF increase 26.4 +/- 9.4 for methohexital-treated patients vs. 24.8 +/- 12.0 for thiopental-treated patients; t = 1.00, df = 82, P > 0.1). Trends approaching significance in treatments 2 and 5 revealed shorter seizures in the thiopental group. However, data on clinical recovery reveals no greater improvement in the methohexital group. Thus, this study calls further into question the premise that choice of barbiturate anesthetic may affect clinical efficacy.

Aged↗

Diagnosis and management of insomnia in older people.

Insomnia is a common but underrecognized problem in elderly patients. Five basic steps can help clinicians identify and treat insomnia. The first step is to ask a single question about sleep at every new patient visit, which goes a long way toward detection of patients with insomnia. The second step is to perform an initial evaluation of the problem, including symptoms, contributing factors, and effects on daytime function. Step three is to determine whether the patient is in crisis. True sleep emergencies are rare, and in most cases, treatment can be delayed until another appointment can be made for a full evaluation of the problem. A sleep evaluation constitutes the fourth step and focuses mainly on a thorough sleep history; blood tests and polysomnography rarely have a role. The final step is intervention. Nonpharmacological strategies are a mainstay of treatment for chronic insomnia, but hypnotics have a role in treating transient insomnia and chronic insomnia that does not improve with nonpharmacological treatment or treatment of associated primary conditions. Pharmacological therapy usually consists of benzodiazepines with short half-lives or nonbenzodiazepines such as zolpidem and zaleplon, although lack of demonstrated efficacy against sleep maintenance difficulties, one of the primary symptoms of insomnia among older people, limits use of these agents. Emerging nonbenzodiazepine agents such as indiplon and eszopiclone may specifically address sleep maintenance problems in elderly patients and are pending Food and Drug Administration (FDA) approval. (Editor's note: Since preparation of this manuscript, the FDA has approved eszopiclone for treatment of insomnia.).

Aged↗

Derivation of research diagnostic criteria for insomnia: report of an American Academy of Sleep Medicine Work Group.

Insomnia is a highly prevalent, often debilitating, and economically burdensome form of sleep disturbance caused by various situational, medical, emotional, environmental and behavioral factors. Although several consensually-derived nosologies have described numerous insomnia phenotypes, research concerning these phenotypes has been greatly hampered by a lack of widely accepted operational research diagnostic criteria (RDC) for their definition. The lack of RDC has, in turn, led to inconsistent research findings for most phenotypes largely due to the variable definitions used for their ascertainment. Given this problem, the American Academy of Sleep Medicine (AASM) commissioned a Work Group (WG) to review the literature and identify those insomnia phenotypes that appear most valid and tenable. In addition, this WG was asked to derive standardized RDC for these phenotypes and recommend assessment procedures for their ascertainment. This report outlines the WG's findings, the insomnia RDC derived, and research assessment procedures the WG recommends for identifying study participants who meet these RDC.

Diagnostic and Statistical Manual of Mental Disord↗

Efficiency of outpatient ECT.

OBJECTIVE: To compare the efficiency of acute-phase outpatient electroconvulsive therapy (ECT), maintenance ECT, and inpatient ECT regarding completion of scheduled treatments. BACKGROUND: Psychiatric research suggests a trend toward greater use of outpatient ECT and that this modality may offer certain advantages over inpatient ECT. Possible concerns about outpatient ECT may be uncompleted treatments due to transportation problems, forgotten appointments, noncompliance with NPO status, or other variables more easily controlled in the inpatient setting. In addition, without the constant monitoring offered by the hospital setting, physicians prescribing outpatient ECT may less successfully gauge the number of required treatments. METHODS: Completion rates of all scheduled ECTs in a tertiary care hospital setting were monitored prospectively for 8 months. Completed treatment totals were estimated by numbers of outpatient treatments billed for, institutional policy prohibiting charges for missed appointments. Outpatients scheduled for more than 1 treatment per week were considered acute-phase patients; maintenance therapy was defined as 1 or fewer treatments per week. RESULTS: Of 257 scheduled outpatient maintenance treatments, 91% were completed compared with 65% of 456 scheduled inpatient treatments. This difference was statistically significant (P < 0.0001; chi2 = 59.6; df = 1). Completion rate of acute outpatient treatments was 62% of 78 scheduled, showing a statistically significant difference from that of maintenance ECT (P < 0.0001; chi2 = 39.1; df = 1). No significant difference was detected between the completion rates of inpatient and acute outpatient ECT. CONCLUSIONS: These findings suggest that the efficiency of maintenance ECT is high, comparing favorably with that of convulsive therapy for the acutely ill, and further support maintenance ECT as a useful and cost-effective modality.

Aged↗

Letting go.

Explore the source record for details and available documents.

Aged↗

Quality of life and function after electroconvulsive therapy.

BACKGROUND: The National Institute for Clinical Excellence in the UK has recommended limiting the use of electroconvulsive therapy (ECT), partly because of the inadequacy of research into the effects of ECT on quality of life and function. AIMS: To examine the effects of ECT on function and quality of life, particularly as they relate to changes in mood and cognition in the month following this therapy. METHOD: We measured changes in quality of life, function, mood and cognition in a prospective sample of 77 depressed patients given ECT. RESULTS: All quality of life and function outcomes were improved at the 2-week and 4-week marks after ECT. Improvement in quality of life was related to mood, whereas improvement in instrumental activities of daily living function was related to improvement in global cognition. CONCLUSIONS: Electroconvulsive therapy is associated with early improvement in function and quality of life. A restrictive attitude towards this therapy is not warranted on the basis of its effects on quality of life and function.

Cognition Disorders↗

Long-term, non-nightly administration of zolpidem in the treatment of patients with primary insomnia.

INTRODUCTION: While it is common practice that hypnotics are used on a non-nightly basis, few investigations have been undertaken to evaluate the efficacy of the intermittent dosing strategy. The present study was designed to further evaluate this issue within a large scale, double-blind, placebo-controlled, long-term trial. METHOD: Patients who met DSM-IV criteria for primary insomnia participated in the study from January 2000 through October 2001. Patients were randomly assigned to 1 of 2 treatment groups (zolpidem 10 mg or placebo) for a period of 12 weeks. Ten pills were provided in foil packs on an every-other-week basis, and patients were instructed to take no fewer than 3 and no more than 5 pills per week. Sleep was evaluated daily with sleep diaries. Pill use was recorded in the sleep diaries. RESULTS: 199 patients (mean +/- SD age = 41.0 +/- 12.8 years; 71% female) were randomly assigned to treatment. On mean, patients receiving zolpidem exhibited (vs. baseline) a 42% decrease in sleep latency, a 52% reduction in number of awakenings, a 55% decrease in wake time after sleep onset, and a 27% increase in total sleep time. These positive clinical gains did not diminish with time and were not associated with dose escalation. There was also no evidence of rebound insomnia. CONCLUSIONS: Over a period of 12 weeks of intermittent treatment with zolpidem, sleep continuity was significantly improved, the clinical gains were sustained, and there was no evidence of subjective rebound insomnia between doses or increases in the amount of medication used during the study interval.

Adolescent↗

Sleep in the Elderly: Burden, Diagnosis, and Treatment.

Insomnia is commonly seen in elderly populations and is associated with numerous individual and socioeconomic consequences. Elderly patients are more likely to suffer from chronic insomnia characterized by difficulty maintaining sleep than difficulty initiating sleep. Management of insomnia in these patients requires very careful evaluation and exclusion of an underlying medical or psychiatric condition. Nonpharmacologic interventions in elderly patients, especially use of behavioral therapy, have demonstrated some success. Commonly prescribed medications have also been effective, though they have limitations. Newer agents currently under investigation for insomnia hold promise for good efficacy and safety in the elderly population. The following review presents clinical studies, survey results, and guidelines retrieved from peer-reviewed journals in the PubMed database using the search terms elderly, temazepam, trazodone, zolpidem, zaleplon, insomnia, and prevalence and the dates 1980 to 2003. In addition, newer research with emerging agents has been included for completeness.

Journal Article↗