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Biomedical subjects

Andrew C Leon

Publications and source records attributed to Andrew C Leon.

45 records · Page 3Linked to original sources
PubMed2003

Toward rapproachment in the placebo control debate. A calculated compromise of power.

In an effort to minimize risk to participants, some investigators avoid using placebo controls in randomized controlled clinical trials (RCT) if an effective treatment is available. An unintended consequence of this approach is that substantially more participants remain acutely ill (i.e., nonresponders) throughout an active-comparator trial than a placebo-controlled trial. This is due to the increased sample size required to detect smaller differences between investigational and proven active agents. The objective of this article is to identify an RCT design that will minimize both the number assigned to placebo and the number of nonresponders. To do so, two aspects of clinical trial design are manipulated: choice of comparator and treatment allocation ratio. Several examples illustrate empirically that placebo-controlled trials that are designed to randomize twice as many participants to the investigational cell could appeal to potential study participants, clinical researchers, and Institutional Review Boards alike.

Algorithms↗
PubMed2002

The long-term natural history of the weekly symptomatic status of bipolar I disorder.

BACKGROUND: To our knowledge, this is the first prospective natural history study of weekly symptomatic status of patients with bipolar I disorder (BP-I) during long-term follow-up. METHODS: Analyses are based on ongoing prospective follow-up of 146 patients with Research Diagnostic Criteria BP-I, who entered the National Institute of Mental Health (Bethesda, Md) Collaborative Depression Study from 1978 through 1981. Weekly affective symptom status ratings were analyzed by polarity and severity, ranging from asymptomatic, to subthreshold levels, to full-blown major depression and mania. Percentages of follow-up weeks at each level as well as number of shifts in symptom status and polarity during the entire follow-up period were examined. Finally, 2 new measures of chronicity were evaluated in relation to previously identified predictors of chronicity for BP-I. RESULTS: Patients with BP-I were symptomatically ill 47.3% of weeks throughout a mean of 12.8 years of follow-up. Depressive symptoms (31.9% of total follow-up weeks) predominated over manic/hypomanic symptoms (8.9% of weeks) or cycling/mixed symptoms (5.9% of weeks). Subsyndromal, minor depressive, and hypomanic symptoms combined were nearly 3 times more frequent than syndromal-level major depressive and manic symptoms (29.9% vs 11.2% of weeks, respectively). Patients with BP-I changed symptom status an average of 6 times per year and polarity more than 3 times per year. Longer intake episodes and those with depression-only or cycling polarity predicted greater chronicity during long-term follow-up, as did comorbid drug-use disorder. CONCLUSIONS: The longitudinal weekly symptomatic course of BP-I is chronic. Overall, the symptomatic structure is primarily depressive rather than manic, and subsyndromal and minor affective symptoms predominate. 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.

Adolescent↗
PubMed2002

The prospectively observed course of illness among depressed patients who commit suicide.

OBJECTIVE: These analyses were conducted to describe the course of illness among patients with major affective disorders who commit suicide. METHOD: Twenty-nine patients who entered a long-term, high-intensity follow-up study of major affective disorders and who later committed suicide within 1 year of their last follow-up interview were individually matched to other patients by age, sex, the presence or absence of lifetime drug or alcohol abuse, time to last interview and polarity. Those who suicided were compared with their controls by depressive and substance abuse morbidity during follow-up, treatment resistance, treatment compliance, suicidal behavior and psychosocial adjustment. RESULTS: Among the various measures used to characterize the course of illness during a mean follow-up of 4.3 years, only those pertaining to suicidal behavior robustly separated the suicide group from their controls. Suicidal behavior in the remote past seemed as predictively important as suicidal behavior during follow-up. CONCLUSION: Of the various features monitored over time in patients with major affective disorder, suicidal behavior itself was the clearest correlate of risk for completed suicide.

Adult↗
PubMed2002

Drugs and firearm deaths in New York City, 1990-1998.

Firearm deaths remain among the leading causes of mortality in the United States. Changing law enforcement activities, incarceration, drug use, and socioeconomic conditions may have played roles in the declining rates of firearm deaths during the 1990s. Using records from the Office of the Chief Medical Examiner, we analyzed the role of drugs in firearm deaths in New York City between 1990 and 1998. Positive drug toxicology was present in over half of all firearm death victims during this time. Cocaine, cannabis, opiates, and alcohol accounted for almost all of these deaths with drug-positive toxicology. There were decreases in cocaine- and alcohol-positive toxicology for firearm deaths in New York City starting in the early 1990s; there was a more gradual decrease in heroin-positive toxicology for firearm deaths. Cannabis-positive toxicology for firearm deaths increased in the early part of the 1990s and then decreased starting in the mid-1990s. Although the disparities between minority and white firearm death rates narrowed during this time, minorities remained about three times more likely to be victims of fatal firearm violence than whites in 1998. The highest firearm death rates were among African American and Latino male decedents, with a larger proportion of Latinos testing cocaine or opiate positive, while a larger proportion of African Americans tested cannabis positive. These results suggest a complex role of drugs in firearm-related deaths.

Adolescent↗
PubMed2002

Assessment and treatment of depression in disability claimants: a cost-benefit simulation study.

The economic burden of depression includes direct costs of treatment, as well as absenteeism and reduced productivity. In this study, we consider the costs and benefits of an intervention to assess and treat depressive symptoms in long-term disability claimants with nonpsychiatric medical illnesses. Cost-benefit simulations were conducted using data from a study sample of long-term disability claimants (N = 1229) and estimates of both the costs of treatment of depressive symptoms and the savings in claims payments for those who return to work as a result of treatment. We show that the savings that stem from returning a very few claimants to work can offset the assumed cost of a comprehensive program for the assessment of depressive symptoms in all claimants and intensive treatment of those with depressive symptoms. The economic and public health benefits both point toward the value of such an intervention for disability claimants.

Comorbidity↗
PubMed2002

Suicide among New York City police officers, 1977-1996.

OBJECTIVE: The authors assessed the suicide rates of New York City police officers during a recent period. METHOD: The authors reviewed death certificates of active New York City police officers who died from 1977 through 1996 (N=668); age-, gender-, and race-specific suicide rates among New York City police officers and the city's residents were determined. RESULTS: The police suicide rate was 14.9 per 100,000 person-years, compared with a demographically adjusted suicide rate of New York City residents of 18.3 per 100,000 person-years. Suicide rates among male police officers were comparable to their reference population. Female police officers had a higher risk of suicide than female residents of New York, but the number of suicides of female police officers was small. CONCLUSIONS: The rate of suicide among New York City police officers is equal to, or even lower than, the suicide rate of the city's resident population.

Adult↗
PubMedDate not supplied

Psychosocial impairment and recurrence of major depression.

Major depressive disorder is often marked by multiple recurrences. Unfortunately, it is difficult to predict specifically which patients will suffer a recurrence. This study examined whether psychosocial impairment is a risk factor for recurrence. A total of 290 subjects with unipolar major depressive disorder according to Research Diagnostic Criteria (RDC) were prospectively followed for up to 15 years as part of the Collaborative Depression Study (CDS), a multicenter longitudinal observational study of the mood disorders. Follow-up data on course of illness and psychosocial functioning were collected with the Longitudinal Interval Follow-up Evaluation (LIFE). The association of psychosocial impairment with recurrence of major depression was examined with mixed-effects logistic regression. The mean (SD) score for psychosocial functioning during recovery from an episode of major depression was 9.0 (2.7), with a possible range of 4 (no impairment) to 20 (severe impairment). For euthymic subjects who recovered from an episode of major depression, elevated psychosocial impairment was significantly associated with subsequent recurrence of major depression, with an odds ratio of 1.12 (95% confidence interval [CI], 1.06 to 1.19). The odds ratio of 1.12 indicates that for each 1-point increase in the functional impairment score, the risk of recurrence increases by about 12%. 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.

Adolescent↗
PubMedDate not supplied

The course of depression in elderly patients.

OBJECTIVE: 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. METHODS: Utilizing 15 years of prospective data from the NIMH Collaborative Depression Study, the authors examined the index episode of MDD and the time until first observed recurrence in those who recovered for subjects in four age-groups defined by age at intake: 17-30, 31-50, 51-64, and 65-79 years. Assessments were conducted every 6 months for 5 years and annually thereafter. Survival analysis examined time until recovery and time to first recurrence. RESULTS: Median time-to-recovery was similar for the four groups. Median time-to-first recurrence was significantly shorter for oldest versus the 51-64-year-old group but not the two other groups. The oldest age-group was distinguished from the younger groups by being more likely to be divorced/widowed/separated, to have primary depression, and to have a history of medical illness, particularly cardiovascular disease or cancer. There was no difference in the generally low levels of pharmacotherapy prescribed during the index episode or the subsequent well interval. CONCLUSIONS: Elderly patients with MDD may have a greater risk of recurrence than younger individuals. Low levels of treatment characterize the somatic treatment in all the study subjects, regardless of age-group.

Adolescent↗