Therapeutic and adverse effects of three dosages (1, 20 and 100 mg daily) of
flutroline, a new 7-carboline with a predinical pharmacological profile similar to active
neuroleptic agents, were compared in a double-blind clinical trial in 25 newly-admitted
schizophrenic patients. Therapeutic effects and extrapyramidal signs were seen at the 20 and
100-mg daily dosages, but not at the 1-mg dosage. Serum prolactin levels were significantly
elevated only at the 100-mg daily dosage.
In a 4-week double-blind trial, 33 patients with depressive neurosis were
randomly assigned to either viloxazine, imipramine or placebo. Statistically significant improvement
was observed in all treatment groups. Imipramine exhibited significant improvement
earlier in depressive symptoms, while viloxazine showed significant improvement earlier
in anxious symptoms. The same frequency of treatment emergent symptoms occurred in
the treatment groups. Premature termination as a consequence of adverse reactions was
required in only 1 viloxazine and 1 placebo patient.
In a multicenter series of trials, viloxazine was compared with imipramine,
amitriptyline, doxepin and placebo in 123 neurotic and endogenous depressive inpatients
and outpatients. While significant period effects reflecting improvement were obtained on
the majority of efficacy variables, no significant differences were obtained among the
treatment groups or depressive types. Imipramine and amitriptyline exhibited more anticholinergic
adverse reactions; while, viloxazine exhibited greater CNS effects. Dizziness
and nausea were much more frequent in neurotic depressives which may be related to their
psychopathology.
SummaryIn a four-week, double-blind, clinical trial thirty-one patients with depressive neurosis were treated with viloxazine, doxepin, or placebo. There were no differences among the three groups in therapeutic effects. Many depressed out-patients improve on placebo. Viloxazine hydrochloride is one of a series of compounds developed to explore the central nervous system activity of the aryloxypropanolamine type of β-adreno-receptor antagonists. Initial clinical studies support the hypothesis that viloxazine has antidepressant properties in man (Bayliss et al, 1974; Bereen, 1973; Pichot et al, 1975; Tsegos and Ekdawi, 1974).
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