The efficacy and tolerability of the new antidepressant Org 3770 were evaluated in a multicentre, double-blind, clomipramine-controlled trial. In total, 174 patients (126 women and 48 men), aged 18-75 years, who were suffering from a moderate or severe major depressive episode, were randomly assigned to 6 weeks of treatment with either Org 3770, 20-80 mg/day, or clomipramine, 50-200 mg/day. All patients were hospitalized at the time of the trial. Depressive symptoms, assessed by 21-item HPRSD, MADRS, BPRS and GAS, improved significantly in both groups of patients after 6 weeks of treatment. Org 3770 was comparable to clomipramine with respect to improvements assessed by all the primary efficacy variables, both in moderately and severely depressed patients. Adverse clinical experiences, such as dry mouth, constipation, tremor, vertigo/dizziness, faintness on rising, and nausea, were reported by fewer patients in the Org 3770-treated group than in the clomipramine-treated group. These differences were particularly pronounced during the first 3 weeks df treatment. With respect to tremor, the difference between the two groups was statistically significant @,-s,ded = 0.03) after both 3 and 6 weeks of treatment. This study shows that Org 3770 is as effective as clomipramine in treating moderate or severe depression, while being better tolerated.

In a double-blind trial, comprising 96 depressed patients, citalopram was compared with maprotiline. The trial period was 6 weeks with ratings (MADRS, CGI) and side effects recordings taking place at Weeks 0, 1, 2, 4, and 6. Both drugs were administered as a single evening dose, 40 or 60 mg for citalopram, and 75 or 150 mg for maprotiline. MADRS total scores and CGI scores showed a highly significant reduction in both groups with no significant difference between them, whether the groups were considered as a whole or whether they were subdivided into endogenously/non-endogenously depressed or melancholic/non-melancholic patients. Side effects were not significantly different, but the maprotiline group showed more anticholinergic side effects, whereas the citalopram group showed more nausea, increased sweating and headache. Two patients on maprotiline were withdrawn because of side effects (hypotension and somnolence in the one case; tremor and insomnia in the other). One patient in each group was withdrawn because of increased transaminases, the citalopram-treated patient having increased values, however, already at baseline. Apart from this, no cardiovascular side effects and no pathological laboratory values related to treatment were observed. The authors conclude that citalopram is a safe antidepressant drug and as effective as maprotiline.

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