Outcome measures and serious asthma exacerbation in clinical trials of asthma controller medications.

Background: With the introduction and approval of several new asthma controller medications for pediatric use, the risk-benefit ratio of these medications has not been fully evaluated.

Objective: To determine whether physiologic pulmonary measurements are superior to other measures in evaluating outcomes and to determine whether asthmatic children have a higher risk of serious adverse events than adults.

Methods: We obtained data on asthma controller medications approved between 1997 and 2010 from the US Food and Drug Administration archives.

The effect of a switch to ziprasidone in an adult population with autistic disorder: chart review of naturalistic, open-label treatment.

Background: The present investigation retrospectively assessed the effect of an open-label switch to ziprasidone from other atypical antipsychotics on behavior, weight, and lipid levels in an adult population with autistic disorder.

Method: We conducted a chart review of 10 adults (mean +/- SD age = 43.8 +/- 6.

Placebo response and antidepressant clinical trial outcome.

Placebo response magnitude is suspected to affect the outcome of antidepressant clinical trials. To evaluate this, 52 randomized, double-blind, placebo-controlled clinical trials obtained from the FDA were examined to correlate placebo response magnitude with trial outcome. The magnitude of symptom reduction, percentage mean change from baseline in the Hamilton Depression Rating Scale (HAM-D), was assessed for patients assigned to placebo or an antidepressant.

Frequency of positive studies among fixed and flexible dose antidepressant clinical trials: an analysis of the food and drug administration summary basis of approval reports.

The assumption that the design of an antidepressant clinical trial affects the outcome of that trial is based on sparse data. We sought to examine if the dosing schedule, either a fixed dose or a flexible dose type, in an antidepressant clinical trial affects the frequency with which antidepressants show statistical superiority over placebo. Randomized, placebo-controlled clinical trials of nine antidepressants approved by the Food and Drug Administration between 1985 and 2000 were reviewed.

An application of the revised CONSORT standards to FDA summary reports of recently approved antidepressants and antipsychotics.

Background: Recent years have seen the introduction of many antidepressants and antipsychotics. Typically, efficacy of these agents is based on published positive clinical trials; however, the Food and Drug Administration (FDA) compiles summary reports of all pivotal randomized clinical trials, which are available for public review under the Freedom of Information Act. They are rarely accessed but may have public health utility.

Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database.

Some studies suggest that more severely ill patients with depression respond well to antidepressants and poorly to placebo, whereas those who are mildly ill respond equally well to antidepressants and placebo. This notion has implications for the design of clinical trials. To further assess and substantiate these putative predictors of antidepressant and placebo response, we assessed the Food and Drug Administration database of 45 phase II and III antidepressant clinical trials.