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Biomedical subjects

Suzanne DiFilippo

Publications and source records attributed to Suzanne DiFilippo.

4 recordsLinked to original sources

Simvastatin causes changes in affective processes in elderly volunteers.

OBJECTIVES: To test for simvastatin-induced changes in affect and affective processes in elderly volunteers. DESIGN: Randomized, clinical trial. SETTING: The Geriatric Behavioral Psychopharmacology Laboratory at the University of Pennsylvania. PARTICIPANTS: Eighty older volunteers, average age 70, with high normal/mildly elevated serum cholesterol. INTERVENTION: Simvastatin up to 20 mg/d or placebo for 15 weeks. MEASUREMENTS: Daily diary records of positive and negative affects and of events and biweekly measures of depressive symptoms. Affect ratings were obtained using the Lawton positive and negative affect scales; independent raters coded the valences of events. RESULTS: Thirty-one of 39 subjects assigned to placebo and 33 of 41 receiving simvastatin completed the study. During biweekly assessments, four subjects on simvastatin and one on placebo experienced depressive symptoms, as manifest by Center for Epidemiological Studies Depression scale scores greater than 16 (exact P=.36). Diary data demonstrated significant effects on affective processes. For positive affect, there was a significant medication-by-time interaction that reflected decreases in positive affect in subjects receiving simvastatin, greatest in those patients whose final total cholesterol levels were below 148 mg/dL. For negative affect, there were significant medication-by-event, and medication-by-event-by-time interactions, reflecting a time-limited increase in the apparent effect of negative events. CONCLUSION: Simvastatin has statistically significant effects on affect and affective processes in elderly volunteers. The decrease in positive affect may be significant clinically and relevant to the quality of life of many patients.

Affect↗

Probing for affective side effects of drugs used in geriatric practice: use of daily diaries to test for effects of metoclopramide and naproxen.

The aim of this study was to develop the use of daily diaries of affects and events as measures of pharmacological effects on affective processes and to apply them to evaluate the possible affective toxicity of metoclopramide and naproxen, two medications commonly used in geriatric practice. In all, 105 adults aged 65 years or older were randomized to receive metoclopramide (up to 40 mg/day), naproxen (up to 1000 mg/day), or placebo under double-blind conditions for a period of 5 weeks. Patients were seen weekly for evaluations of affective and cognitive outcomes as well as safety. In addition, patients kept diaries with daily records of positive and negative affect and reports of significant daily events. Findings included mixed model analyses of drug assignment, time, events, and interactions for both positive affect and days with significant negative affect. Subjects exhibited high levels of adherence in completing daily diaries. Neither the pattern of dropouts nor the weekly assessments demonstrated significant drug effects on mood or affect. However, diary data demonstrated that metoclopramide increased the apparent impact of negative events on both positive and negative affect relative to placebo, and that naproxen increased the apparent impact of positive events on positive affect and, possibly, of negative events on negative affect relative to placebo. The findings confirm the utility of diary methods for studying drug effects on affective processes in normal elderly subjects. They suggest that both metoclopramide and naproxen can affect the associations between daily events and affects. If replicated, they would demonstrate that drug effects can extend beyond the intensity of affect and/or the emergence of full-fledged psychiatric disorders to include moderation of the interactions between daily events and affect.

Affect↗

Probing the safety of medications in the frail elderly: evidence from a randomized clinical trial of sertraline and venlafaxine in depressed nursing home residents.

BACKGROUND: In nursing home residents and other frail elderly patients, old age and potential drug-drug and drug-disease interactions may affect the relative safety and efficacy of medications. The purpose of this study was to examine the efficacy and tolerability of venlafaxine and sertraline for the treatment of depression among nursing home residents. METHOD: The study was a 10-week randomized, double-blind, controlled trial of venlafaxine (doses up to 150 mg/day) versus sertraline (doses up to 100 mg/day) among 52 elderly nursing home residents with a DSM-IV depressive disorder and, at most, moderate dementia. The primary measure of outcome was the Hamilton Rating Scale for Depression (HAM-D). Adverse events were monitored and recorded systematically during the trial. RESULTS: Twelve subjects were discontinued due to serious adverse events (SAE), 5 were discontinued due to other significant side effects, and 2 withdrew consent. Tolerability estimated by the time to termination was lower for venlafaxine than sertraline for serious adverse events (log rank statistic = 5.28, p =.022), for serious adverse events or side effects (log rank statistic = 8.08, p =.005), or for serious adverse events, side effects, or withdrawal of consent (log rank statistic = 10.04, p =.002). Mean (SD) HAM-D scores at baseline were 20.2 (3.4) for sertraline and 20.3 (3.7) for venlafaxine; intent-to-treat endpoint HAM-D scores were 12.2 (5.1) and 15.7 (6.2) (F = 3.45; p =.069). There were no differences in categorical responses for the intent-to-treat sample or completers. CONCLUSION: In this frail elderly population, venlafaxine was less well tolerated and, possibly, less safe than sertraline without evidence for an increase in efficacy. This unexpected finding demonstrates the need for systematic research on the safety of drugs in the frail elderly.

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Pharmacologic treatment of depression in nursing home residents: a mental health services perspective.

Over the past 10 to 15 years, there has been marked progress in clinical research on depression in nursing home residents. There have also been significant changes in federal regulations designed to improve the quality of care. In 1987, only 10% of nursing home residents diagnosed with depression were receiving treatment, but by 1999,25% of all residents were receiving antidepressants. We report on two studies: one demonstrating that treatment for depression has a substantial, ecologically relevant impact in the nursing home and another demonstrating that profound changes have occurred in the clinical epidemiology of depression and its treatment in the nursing home. Although the numbers of nursing home residents receiving antidepressants have increased dramatically, there are now second-generation problems that must be addressed to ensure the delivery of effective treatment. Developing models to ensure quality of care will require focused mental health services research.

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