This 28-day study (3) compared alprazolam and placebo in 462 clinically anxious patients whose depressed mood indicated at least moderate severity in the Hamilton Anxiety Rating Scale (HARS). The patients ranged in age from 18 to 70 years. Patients with obvious sociopathy or psychosis, primary affective disorder, or alcoholism, and those requiring medication other than the study drugs were excluded, as were patients who were known to be sensitive to ben­zodiazepines or who had serious liver, kidney, cardiovascular, or pulmonary disease. After a 4- to 7-day washout and screening period, the patients were randomly assigned to alprazolam (242) or placebo (220) regimens within a dosage range of 2 to 12 capsules per day (0.25-mg alprazolam capsules). The patients’ anxiety symptoms were assessed at the beginning of the treatment period and after 1, 2, and 4 weeks of medication on the HARS, a 35-item Self-Rating Symptom Scale (SRSS), a Target Symptoms Record, and the Patient’s and Physician’s Global Impressions scales. Side effects, or treatment-emergent symptoms, were recorded on a symptom and side effects checklist initially and at weeks 1, 2, and 4; symp­toms that appeared or worsened during treatment were considered side effects. Alprazolam was more effective than placebo in relieving anxiety associated with depressed mood on every efficacy measurement of each assessment period. By the fourth week, the difference between the two treatment groups was sig­nificant (p < 0.012) on almost every item of both the HARS and the SRSS (2,3). According to the Patient’s Global Impressions of how much change had oc­curred and the Physician’s Global Impressions of therapeutic effect, more than 75% of the patients given alprazolam responded favorably, whereas less than one-third of patients given placebo responded to treatment. The treatment-emergent symptom reported most often was drowsiness, which did not differ significantly in frequency between the groups. No other treatment-emergent symptom was reported by a significant number of patients in either group. Side effects caused four patients on placebo but no patients on alprazolam to drop out of the study.

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