A multicenter double-blind comparison of nefazodone and paroxetine in the treatment of outpatients with moderate-to-severe depression.

BACKGROUND: The efficacy, safety, and tolerance of nefazodone and paroxetine in the treatment of depressed outpatients were compared in a randomized, double-blind parallel group study at 20 centers in the United Kingdom and Republic of Ireland. METHOD: The study population comprised 206 outpatients meeting DSM-III-R criteria for a moderate-to-severe nonpsychotic major depressive episode. Patients considered to be at serious risk of suicide were excluded from participation in the study. After a drug-free baseline phase of 1 to 4 weeks, patients were randomly assigned to treatment with either nefazodone or paroxetine. Outcome measures for efficacy included the Clinical Global Impressions scales, Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Montgomery-Asberg Depression Rating Scale, and Patient Global Assessment scale. Tolerance and safety were assessed using spontaneously reported adverse events, vital signs, and laboratory investigations. RESULTS: There were no significant differences between the groups in clinical outcome. Analysis of the efficacy measures revealed a consistent and continuous improvement in both groups. A similar proportion of patients in each group discontinued treatment owing to adverse events: 15 (14%) in the nefazodone group and 13 (13%) in the paroxetine group. CONCLUSION: Nefazodone and paroxetine have similar efficacy and tolerability in the treatment of outpatients with major depression.

A double-blind comparison of oral amitriptyline and low-dose intramuscular flupenthixol decanoate in depressive illness.

Fifty-seven hospital out-patients with depressive symptoms were studied in a double-blind manner for up to 4 weeks, 30 whilst being treated with intramuscular flupenthixol decanoate (5 to 10 mg/fortnight) and 27 with oral amitriptyline (75 to 150 mg/day). The results of assessment using the Hamilton Rating Scale for Depression, the Leeds Self-Rating Scale for Depression and the Clinical Global Impressions severity scale showed that both therapies were effective in resolving depression in the patients studied. The two treatments were well tolerated and side-effect profiles were similar, dry mouth, faintness/dizziness and drowsiness being the most frequently reported adverse events. Extrapyramidal signs were seen in similar numbers of patients in each treatment group. One patient from each of the two groups was withdrawn from therapy before the end of the study because of adverse events.