A double-blind comparison of fluoxetine, imipramine and placebo in outpatients with major depression.

Fluoxetine is the first selective serotonin reuptake inhibitor antidepressant to be marketed in the U.S. In this double-blind trial fluoxetine was compared with imipramine and placebo among 198 outpatients with DSM-III major depression, of whom 145 completed at least 2 weeks of active treatment and were evaluated for efficacy. Significantly fewer patients in each active drug group terminated early due to lack of efficacy compared to placebo. Both imipramine and fluoxetine were significantly superior to placebo on most measures. There were no consistently significant differences between the two active drugs although a trend favored imipramine on a number of measures. Fluoxetine was generally well tolerated. Significantly more imipramine than placebo patients terminated early due to side-effects while the fluoxetine-placebo difference was not significant. The results support previous studies which suggest fluoxetine's superior side-effect profile and the approximate antidepressant equivalence of fluoxetine and TCAs.

Multicenter placebo-controlled evaluation of nomifensine treatment in depressed outpatients.

Outpatients aged 18-65 who met Feighner et al. criteria for primary affective disorder-depression and had Hamilton Depression Rating Scale (HDRS) scores greater than or equal to 20 were randomly assigned to receive nomifensine (N = 61) or placebo (N = 63) for 4 weeks. On all measures of efficacy (HDRS, Clinical Global Impressions, Hopkins Symptom Check List, Brief Psychiatric Rating Scale), patients treated with nomifensine showed significant improvement compared to placebo patients; improvement was evident after 1 week on some scales. No clinically important changes were seen over the course of treatment in findings of physical examinations, ECGs, and clinical laboratory evaluations. Side effects associated with active treatment were mild to moderate in severity and rarely led to cessation of therapy. Thus, significant clinical improvement was seen in these moderately to severely depressed outpatients, without significant adverse experiences.

A double-blind comparative evaluation of the efficacy and safety of nomifensine, imipramine, and placebo in depressed geriatric outpatients.

Nomifensine, imipramine, and placebo were compared in 61 depressed geriatric outpatients over a 35-day period. At average daily doses of 150 mg, nomifensine and imipramine were significantly more effective than placebo in reducing symptoms of depression in this sample of elderly depressed patients. Nomifensine and imipramine were generally comparable in clinical effect; 78% of the nomifensine-treated patients were rated as improved at the end of treatment as compared with 64% of imipramine and 20% of placebo patients. The findings suggest a more favorable side effect profile for nomifensine, which was associated with a lower frequency of sedating and anticholinergic effects than was seen in the imipramine group.

The use of bupropion in hospitalized depressed patients.

Bupropion and placebo were compared in hospitalized nonpsychotic depressed patients over a 28-day period. It was found that bupropion was significantly more effective than placebo in alleviating depression and that the incidence of adverse effects was similar in bupropion- and placebo-treated patients.

A double-blind comparative trial with mianserin and amitriptyline in outpatients with major depressive disorders.

1 A double-blind trial with parallel treatment groups was conducted to compare the safety and efficacy of mianserin with amitriptyline. 2 This was a six week trial with weekly visits. Measurements at each visit included: 21 item Hamilton Depression (HAMD) Scale. Clinical Global Impression (CGI) Scale and Treatment Emergent Symptom Scale (TESS). 3 Mianserin and amitriptyline were comparable with respect to efficacy. 4 More adverse experiences were reported by amitriptyline patients. The predominant amitriptyline adverse experiences were of the anticholinergic type; the predominant mianserin adverse experience was drowsiness/fatigue. 5 The Efficacy Index (EI), a scale combining efficacy and adverse experiences, clearly demonstrated the superiority of mianserin over amitriptyline.

A double-blind, controlled evaluation of zimeldine, imipramine and placebo in patients with primary affective disorders.

Zimeldine, imipramine and placebo were studied in a randomized, double-blind, parallel group comparison of 119 patients with primary affective disorders. These out-patients were between 18 and 65 years of age and all received placebo single-blind during an initial 3-7-day washout period. During the subsequent 6-week double-blind period, patients were titrated from 50 mg b.d. to 150 mg b.d. with zimeldine, a potent and selective inhibitor of 5-HT reuptake, with imipramine, an inhibitor of noradrenaline and 5-HT reuptake, or with a corresponding number of placebo capsules. The zimeldine treatment group had significantly lower mean HAM-D scale total scores than the placebo and imipramine groups at week 4 and last available assessment. There was a significantly greater proportion of patients showing an improvement of 50% or more in HAM-D score, among the zimeldine group than in the placebo group at week 4, and among the imipramine group at weeks 4, 6 and last available assessment. The Clinical Global Impression (CGI) scales and the 56-item Hopkins Symptom Check-list (HSCL-56) self-rating inventory both showed significantly more improvement in the zimeldine patients than in the placebo or the imipramine patients. Fewer zimeldine patients reported adverse experiences than imipramine patients. Dry mouth was the most frequently reported adverse experience, occurring significantly more often in the imipramine group than the zimeldine or the placebo groups; significantly more zimeldine than placebo patients reported dry mouth. Headache was the only other adverse experience which occurred more often in the zimeldine than in the placebo group. The imipramine group had consistently higher mean pulse rates than the other two groups, and postural hypotension was also more common in the imipramine group.

A double-blind comparison of buspirone and diazepam in outpatients with generalized anxiety disorder.

The safety and antianxiety and antidepressive effects of buspirone (average 16.5 mg/day) were compared in a double-blind trial with those of diazepam (15 mg/day). The two drugs were nearly equivalent in relieving symptoms of both anxiety and depression in 100 patients. Scores on the impaired cognition factor of the SCL-56 and confusion factor of the POMS showed significantly greater improvement with buspirone than with diazepam. Side effects, such as sedation and drowsiness, were significantly more frequent and severe with diazepam. Buspirone may be particularly indicated for anxious patients with associated depression.