A comparative clinical trial of fluoxetine, mianserin and placebo in depressed outpatients

Abstract

Fluoxetine, a selective serotonin reuptake inhibitor, was compared with mianserin and placebo in a double-blind study. In total, 81 depressed patients were included. Patients were rated weekly on the Hamilton Depression Rating Scale (HDRS) and the Montgomery & Asberg Depression Rating Scale (MADRS). The duration was 6 weeks, and 52 patients completed the study. Significantly more patients on fluoxetine improved than patients on placebo. For mianserin no significant differences were found with either fluoxetine or placebo. Mean HDRS at the end of the study was also statistically significantly lower for fluoxetine, but not for mianserin, than placebo. Subscores of the MADRS showed improved sleep on mianserin at weeks 2 and 3. Suicidal feelings were reduced to a greater degree on fluoxetine than on mianserin and placebo at weeks 6 and 7. Fluoxetine induced weight loss, while patients on mianserin gained weight. Side effects were present in most patients on the two active drugs; those on fluoxetine experienced nausea and vomiting, and those on mianserin drowsiness.

Clinical significance of 5-HT uptake inhibitors

“…A significant advantage has been shown for fluoxetine compared with a comparator antidepressant and placebo in reduction of suicidal thoughts, measured on the suicidal thoughts item of MADRS (Montgomery and Asberg, 1979), during treatment with fluvoxamine and fluoxetine compared with a comparator antidepressant and placebo (Jacobs and Wakelin, 1986;Muijen et al, 1988). This is consistent with similar reports for other 5-HT uptake inhibitors, zimelidine and citalopram (de Wilde et al, 1985).…”

A randomised, double-blind comparison of the efficacy and safety of citalopram compared to mianserin in elderly, depressed patients with or without mild to moderate dementia

“…In double-blind comparisons of¯uoxetine (20±80 mg) and mianserin (20±80 mg) over 6 weeks, the two drugs showed equivalent ecacy as measured on the Hamilton Depression Rating Scale in younger patients (Muijen et al, 1988) as well as in the elderly (La Pia et al, 1992). In a similar study,¯uvoxamine (100±150 mg) was compared with mianserin (30± 60 mg) in patients aged 18±60 years, over 8 weeks (Lavergne et al, 1996).…”

“…It has been used as a reference treatment in several other studies at recommended dose levels of 20±60 mg (Moon and Jesinger, 1991;Muijen et al, 1988). Mianserin enhances central noradrenergic turnover, presumably by blocking presynaptic noradrenergic receptor sites.…”

Antisuicide Properties of Psychotropic Drugs: A Critical Review

“…Additional small, short-term treatment studies of fluoxetine, 140 nortriptyline, 141 and phenelzine 141 all found the antidepressant to be statistically superior to placebo in reducing baseline suicidal ideation. Minimal data exist regarding the use of antidepressants in conjunction with other psychotropics, such as mood stabilizers, apart from the reported uncontrolled and nonrandomized observations by Angst and colleagues, 15 in which suicide completions were less frequent during antidepressant coadministration with lithium as compared to lithium without antidepressants.…”