Patients (n = 490) suffering from a major depressive episode according to DSM-III criteria were randomly allocated to groups receiving either moclobemide, imipramine, or placebo treatment. Subjects were treated as out-patients for 6 weeks. On overall assessment of efficacy and on results of the Hamilton Rating Scale for Depression, both moclobemide and imipramine were superior to placebo, but the differences between moclobemide and imipramine were not significant. Premature termination due to insufficient efficacy was more frequent with placebo than with moclobemide or with imipramine, these differences being significant. The overall assessment of tolerance clearly favoured placebo and moclobemide over imipramine. This was also reflected in the frequency of premature terminations due to poor tolerance, as well as in the frequency of adverse events, which were highest in the imipramine group. The only cardiovascular finding was an increase of the mean heart rate with imipramine, maximum at the end of week 1, while placebo and moclobemide displayed no relevant changes. There were no other important drug-related changes.

Rats with chemical diabetes were submitted to repeated restraint in order to investigate the diabetogenic potentiality of stress. Material and MethodUnfasted, adult Sprague-Dawley rats of about 150 g initial b.w. were employed. Blood and urine glucose determinations were performed by the glucose oxidase strip method (Vargas, Bronfman and Kawada 1974). Basal glycemia for normal rats was 92 + 0.6 mg% (M + SEM of 104 determinations). The samples were taken immediately before stress (time 0), every 60 min along 240 minutes. Restraint stress was provoked by immobilization of the rats on the operating table by moans of rubber bands tied to their extremities, procedure that permits escape movements.Two series of rats, 67 with 80% pancreatectomy and 14 with 90 % pancreatectomy (80%-P~ and 90%-P~), were submitted to repeated restraint stress. The stress began 7 days and 3 months after pancreatectomy, respectively. The 80% pancreatectomy was performed following the procedure reported by Bates and Garrison (1967).A third series of 20 intact male and 25 intact female rats was used as control. Another series consisting of 5 controls and 5 80 %-P~rats was studied at mid-day by the Oral Glucose Test (200 mg/100 g, 40% glucose solution).The post-stress glycemia-glycosuria response was classified as: a) hyperglycemic response when glycemia was between 150 and 179 mg%, without glycosuria; b) diabetic response when glycemia rose over 180 mg% accompanied by glycosuria, and came back to normal values within 4 hours; c) transient diabetes when the diabetic response lasted 8 hours or more, but returned to normal levels, and d) permanent diabetes when the diabetic response was irreversible.

No abstract

Sixty out-patients with different nosological types of depression were assigned at random to three different treatment groups and were treated under double-blind conditions for 6 weeks. Two groups received diclofensine in capsules of either 15 or 25 mg, and a third group received capsules with imipramine 25 mg. The dosage schedule provided an initial dose of 2 capsules/day which was to be gradually increased up to a maximum dose of 9 capsules/day. The daily mean dosages actually given over the entire trial period were 64.0 mg diclofensine for group I, 97.6 mg diclofensine for group II, and 102.9 mg imipramine for group III. All treatment groups showed a good improvement of the patients’ clinical states within the 6-week period, but the imipramine-treated patients improved more slowly than the diclofensine-treated patients. This was demonstrated by the mean total scores of the Hamilton Depression Rating Scale (HDRS). Evaluation of different factors of the HDRS yielded differences between the two drugs in favour of diclofensine for the factor ‘inhibition’ from the end of week 1 until the end of week 3 and for the factor ‘somatic complaints’ during week 3. Side effects were – dose dependently – less frequent, less severe, and lasted shorter in the diclofensine-treated patients than in the imipramine-treated ones. The most frequently reported side effects in the diclofensine-treated patients were dry mouth, insomnia, dizziness, and agitation. In the imipramine group side effects were mainly dry mouth, tremor, dizziness, and sleepiness. In conclusion, this study shows an impressively faster onset of efficacy of diclofensine over imipramine, a finding which should be replicated by further studies.