This report presents the results of a retrospective analysis of pooled efficacy data from eight studies in which buspirone was compared to placebo in 520 patients with generalized anxiety disorder (GAD). In addition to evaluating overall efficacy in the composite patient data base, four criteria were used to identify subsets of patients with GAD who had coexisting depressive symptoms of at least moderate intensity: (1) a score of ≧ 2 on the Hamilton Anxiety (HAM-A) Rating Scale item 6 (depressed mood), (2) a score of ≧ 2 on the Hamilton Depression (HAM-D) Rating Scale item 1 (depressed mood), (3) a HAM-D total score of ≧ 18, or (4) a HAM-D Retardation Factor value (items 1,7,8, and 14) greater than the median for the group. Overall, patients treated with buspirone demonstrated significant (p ≤ 0.001) improvement over baseline in total HAM-A scores compared to patients who received placebo. Buspirone also produced significant (p ≤ 0.001) global improvement compared to placebo as assessed by the attending physician. Of the GAD patients stratified according to the four criteria for coexisting depressive symptoms, a substantial percentage (44-64%) of the total patient sample exhibited significant depressive symptoms as part of their anxiety disorder. Patients with GAD and coexisting depressive symptoms of at least moderate intensity exhibited significantly greater improvement with buspirone compared to placebo treatment regardless of the stratification criterion used. They also responded at least as well or better to buspirone therapy as did those with GAD who had less intense depressive symptoms. Weekly ratings indicated that buspirone produced a progressively increasing anxiolytic response relative to placebo throughout the 4-week double-blind treatment period. These findings indicate that buspirone is an effective anxiolytic for patients with GAD who experience coexisting depressive symptoms regardless of the intensity of those symptoms.