A total of 115 elderly patients (60-85 years of age) with DSM III diagnosis of major depressive episode were randomly assigned to 6 weeks of treatment with either mirtazapine, 15-45 mg/day, or amitriptyline, 30-90 mg/day. Efficacy was assessed biweekly, using the Hamilton Rating Scale for Depression (HRSD) and Montgomery and Asberg Depression Rating Scale (MADRS) as primary outcome variables. The treatment with both drugs resulted in a similar reduction of total HRDS and MADRS scores, with no statistically significant differences between treatment groups at any assessment point or at endpoint. Statistically significant differences favouring amitriptyline were present according to CGI-Global Improvement Scale at endpoint, HRDS cognitive disturbance factor at weeks 2, 4 and 6 and endpoint and retardation factor at week 6. Adverse events were reported by a similar number of patients in both treatment groups. Additional research is needed to assess further the efficacy and tolerability of mirtazapine among elderly depressed patients.
Fluvoxamine is a highly selective 5-HT reuptake inhibitor used in the treatment of affective disorder. It is superior to placebo and comparable in efficacy to tricyclic antidepressives, but with a differing side effect profile and reduced cardiotoxicity.Fluvoxamine and dothiepin were compared in a six-week double-blind study of hospital outpatients with "a major depressive episode" (DSM III). Initial daily dosage was fluvoxamine 100 mg or dothiepin 75 mg. This was adjusted after the first week to a maximum of fluvoxamine 300 mg or dothiepin 225 mg. Efficacy was measured using the Hamilton Depression Rating Scale (HAMD), Clinical Global Impression (CGI) and Clinical Global Improvement (CGlmp).Seventy-eight patients were entered into the study. Five were excluded from the analysis because they did not satisfy the entry criteria. Data from 73 patients were analysed, of whom 50 completed the study. Both treatments were confirmed to be highly effective. HAMD scores showed a 60 per cent improvement at Week 6 which was reflected by the CGI and CGlmp results. There were no significant differences in efficacy, although there was a trend towards earlier improvement in suicide ideation in the fluvoxamine group.Both treatments were well tolerated. Concurrent effect profiles were consistent with each drug's pharmacology. Dothiepin was associated with significantly more anticholinergic effects, particularly dry mouth, whilst fluvoxamine was associated with more nausea and vomiting although this was not significant. This study shows fluvoxamine to be as effective as dothiepin but with a lower incidence of anticholinergic effects.
A controlled release (CR) formulation of remoxipride (Roxiam(®), Astra) given once-daily was compared to immediate release (IR) remoxipride given twice-daily, with respect to efficacy and tolerability, in a 4-week multicentre parallel-group dose titration (200-600 mg/day) study with acutely ill schizophrenic patients. Forty- three patients received remoxipride CR (mean dose 344 mg/day) and 49 patients received remoxipride IR (mean dose 346 mg/day). Efficacy was assessed using the Kolakowska version of the Brief Psychiatric Rating Scale (BPRS score of ≥ 18 points at entry) and the Clinical Global Impression scale (CGI), while extrapyramidal symptoms were rated using the Simpson and Angus scale. Both formulations of remoxipride produced clinical improvement, with the BPRS median total score falling from 35 at baseline to 16 at last rating in the remoxipride CR group, and from 33 to 12.5 in the remoxipride IR group. More than 70% of the patients in both groups were assessed as 'much improved' or 'very much improved' according to the CGI scale. Both formulations of remoxipride were well-tolerated, with a low incidence of treatment-emergent adverse symptoms, including extrapyramidal side effects. No statistically significant differences were detected between the treatment groups with regard to efficacy, safety or tolerability.
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