In a double-blind, randomized, controlled, multicenter clinical trial in general practice, lasting 7 weeks, a fixed dose of moclobemide (400 mg daily) was compared with a fixed dose of clomipramine (150 mg daily). A total of 147 patients with DSM-III-R major depression were included in the study. After a 1-week drug-free washout period, patients were stratified, according to total scores on the Hamilton Rating Scale for Depression (HAM-D), into two groups-HAM-D total scores, 11 to 15 points, and HAM-D total scores, 16 points or more. A comparison of the therapeutic effect of the two treatments was based on HAM-D total scores and the classification of patients into therapeutic response categories defined on the basis of total rating score, complete response, HAM-D <or=to7 points; partial response, HAM-D, 8 to 15 points; or no response, HAM-D >or=to16 points. The Newcastle Diagnostic Rating Scale (1965) was used to classify the patients into two groups, endogenous and nonendogenous. Adverse events were registered by use of the UKU side effect scale. Clinical global assessments of severity, efficacy, and tolerance were completed during the active treatment period. Compliance to treatment was based on levels of the drugs in plasma and the number of returned capsules. One hundred forty-two patients were evaluated for clinical effects. The results of the efficacy analyses showed therapeutic equivalence between moclobemide and clomipramine. There were no differences in the outcome of the two treatment groups or the two diagnostic groups (endogenous and nonendogenous). Treatment with clomipramine resulted in a higher dropout rate (40%), mostly as the result of adverse events and a statistically higher frequency of side effects (p < 0.05); clomipramine was also significantly less tolerated than moclobemide (p < 0.0001). Important differences were found in the clinical characteristics between the included patients and a similar patient sample from an inpatient study; these clinical characteristics explained some of the differences in the conclusions of the trials with moclobemide and other new antidepressants. (J Clin Psychopharmacol 1995;15[Suppl 2]:24S-30S)
(KRAGH-SORENSEN, STAGE) Department of Psychiatry, Odense University Hospital, Odense; (MULLER, ANDERSEN) General Practice and (BUCH) Roche a/s, Medical Department, Copenhagen, Denmark
Address requests for reprints to: Dr. Per Kragh-Sorensen, Odense University Hospital, Department of Psychiatry, Odense, Denmark.