This study was planned and performed with the aim of monitoring system­atically both patient characteristics and the outcome of different treatment mo­dalities under routine clinical practice conditions. Based on previous reports and personal clinical experiences, a generally accepted standard treatment with IMI and a promising but less widely tried treatment with CLO, both in flexible dosages, were compared. The design allowed for baseline assessment and long-term routine monitoring of treatment response in a large sample of subjects with panic disorder. The advantages over other clinical reports are the random assignment of drugs, the systematic assessment using standardized rating scales and the opportunity to compare this sample of patients with a previously collected sample that was used in a general clinical trial by the same group. The 152 patients selected for the IMI-CLO study to date by a broad interpre­tation and application of DSM-III-R criteria differed surprisingly little from 80 other patients with panic disorder, selected by the same research group, according to more strict diagnostic criteria for a worldwide multicenter study of panic disorder. The demographic and psychopathological characteristics of the two groups widely overlapped. No significant differences were found in age, sex, number of spontaneous and situational panic attacks, percentage of time antic­ipatory anxiety distressed the patients, level of phobic avoidance, depressive mood (HDS) or social disability. In addition, these findings were confirmed by patients’ self-evaluations. The two groups did not differ at baseline on the HSCL factors of anxiety, phobic anxiety, or somatization. The CLO-IMI sample was significantly higher on the obsessive-compulsive factor, and their depression self-ratings were nearly significantly higher. The rank ordering of scores on the HSCL 9-factor profile was practically identical for the two samples, although the general profile level was somewhat higher for the CLO-IMI sample. These observations need further study. Panic disorders appeared to be sharply defined in both groups by profiles with greatest elevations on the anxiety, phobic anxiety, and somatization factors. Even though we included almost the whole spectrum of patients with panic attacks, including multiple diagnoses in axis one, the major clinical features of the CLO-IMI sample did not differ significantly from the typical symptomato-logical picture of panic disorder as presented by the Pisa subsample of what is probably the most carefully selected sample of panic disorder ever undertaken. This evidence supports the homogeneity, reliability, and stability of the panic disorder diagnosis across various patient samples and clinicians, and observa­tion times. The diagnostic subdivision of panic disorder according to DSM-III-R is based essentially on different degrees of phobic avoidance (none, limited, extreme). These diagnostic subtypes did not relate to different rates of drug response to IMI or CLO. This finding supports a more unitarian nosological conceptualiza­tion of panic disorder. Clinical response and side effects have not differed appreciably between the IMI and CLO groups. At similar dosages, both drugs appeared equally effective on the overall symptomatology of panic disorder and agoraphobia. Significant advantages for CLO were found on clinicians’ ratings of the psychic and somatic anxiety items from the HDS. On the former, CLO had faster action with an advantage at 2 weeks, but at 6 and 10 weeks, CLO and IMI were comparable. The CLO advantage on somatic anxiety was apparent at weeks 2 through 10. Since this evidence for treatment differences is relatively limited in view of the number of statistics applied, we prefer not to overinterpret it at this time. An important implication of our findings may be that CLO’s more predominantly serotonin-inhibiting effect does not seem to determine a different spectrum of activity in panic disorder. These data do not clearly support or indicate whether the panic attacks were blocked before the anticipatory anxiety and avoidance behavior decreased. A trend was noticed in favor of a better response of CLO on situational attacks, anticipatory anxiety, and phobic avoidance. Subsequent analyses of all data from the entire sample when the study is completed should better clarify these latter points.

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