Publications

OBJECTIVE

To determine the validity of a two-question case-finding instrument for depression as compared with six previously validated instruments.

DESIGN

The test characteristics of a two-question case-finding instrument that asks about depressed mood and anhedonia were compared with six common case-finding instruments, using the Quick Diagnostic Interview Schedule as a criterion standard for the diagnosis of major depression.

SETTING

Urgent care clinic at the San Francisco Department of Veterans Affairs Medical Center.

PARTICIPANTS

Five hundred thirty-six consecutive adult patients without mania or schizophrenia.

MEASUREMENTS AND MAIN RESULTS

Measurements were two questions from the Primary Care Evaluation of Mental Disorders patient questionnaire, both the long and short forms of the Center for Epidemiologic Studies Depression Scale, both the long and short forms of the Book Depression Inventory, the Symptom-Driven Diagnostic System for Primary Care, the Medical Outcomes Study depression measure, and the Quick Diagnostic Interview Schedule. The prevalence of depression, as determined by the standardized interview, was 18% (97 of 536). Overall, the case-finding instruments had sensitivities of 89% to 96% and specificities of 51% to 72% for diagnosing major depression. A positive response to the two-item instrument had a sensitivity of 96% (95% confidence interval [CI], 90-99%) and a specificity of 57% (95% CI 53-62%). Areas under the receiver operating characteristic curves were similar for all of the instruments, with a range of 0.82 to 0.89.

CONCLUSIONS

The two-question case-finding instrument is a useful measure for detecting depression in primary care. It has similar test characteristics to other case-finding instruments and is less time-consuming.

BACKGROUND

Increased serum levels of antigen-specific IgE are often associated with allergic respiratory disorders. RhuMAb-E25, a recombinant humanized monoclonal antibody, decreases free serum IgE by forming biologically inactive immune complexes with free IgE.

OBJECTIVE

We hypothesized that rhuMAb-E25 would decrease total serum IgE and reduce symptoms.

METHODS

Two hundred forty subjects were enrolled into five groups to determine the safety, tolerance, and efficacy of repeated administration of rhuMAb-E25 in adults with ragweed-induced allergic rhinitis and to explore the pharmacodynamic relationship of rhuMAb-E25 and IgE. One hundred eighty-one subjects received an initial intravenous loading dose (day 0, 1 month before ragweed season), followed by administration of rhuMAb-E25 (in mg/kg body weight) of 0.15 mg/kg subcutaneously, 0.15 mg/kg intravenously, or 0.5 mg/kg intravenously on days 7, 14, 28, 42, 56, 70, and 84. A subcutaneous placebo group and an intravenous placebo group were included. The total evaluation time included the 84-day treatment period, followed by a 42-day observation period.

RESULTS

Adverse events were mild, and no differences were observed in the rates between the three active and two placebo treatment groups. Ragweed-specific IgE levels correlated with symptom scores. RhuMAb-E25 decreased serum free IgE levels in a dose- and baseline IgE-dependent fashion. However, only 11 subjects had IgE levels that were suppressed to undetectable levels (< or = 24 ng/ml), a sample too small to demonstrate significant differences and clinical efficacy. Thus the case for efficacy was not proven. Nonetheless, the study confirms that it is safe to repeatedly administer rhuMAb-E25 over a period of months.

CONCLUSIONS

Because rhuMAb-E25 decreased serum free IgE in a dose-dependent fashion and because symptom scores correlated with antigen-specific IgE levels, the results suggest that if given in adequate doses, rhuMAb-E25 should be an effective therapy for allergic diseases.