Table 2.

Overview of dosing and tolerability across unpublished double-blind and single-blind clinical trials from 1974 to 1976 investigating viloxazine immediate-release (original formulation) in adults with depression

Principal investigator, study site, year	Study title	Number of patients [treatment duration]	Patient type(s)/disorder(s)	Viloxazine dose, mg/day [regimen]	Available tolerability commentarya
Ekdawi, UK, 1974	Double-blind controlled comparison of imipramine and viloxazine in depression	59 (29 viloxazine) [6 weeks, compared to imipramine]	Depression [inpatients]	300 mg [100 mg tid]	50% treated patients had no AEs after 2 weeks
Hamilton, UK, 1974	Double-blind between-patient study of viloxazine vs. placebo in depression	36 (21 viloxazine) [1 week]	Depression [inpatients]	400 mg [100 mg qid]	20/21 treated, 12/15 placebo reported side effects
Magnus, UK, 1974	Double-blind four-way crossover study of viloxazine, perphenazine, the combination, and placebo in depression	24 [2 weeks per drug, crossover design compared to perphenazine]	Depression and anxiety [inpatients]	150 mg [50 mg tid]	Most common AE: mild nausea
Magnus, UK, 1974	Double-blind four-way crossover study of viloxazine, diazepam, the combination, and placebo in depression	27 [2 weeks per drug, crossover design compared to diazepam]	Depression and anxiety [outpatient]	150 mg [50 mg tid]	AEs were not significantly greater than placebo
Floru and Czarny, Germany, 1976	Double-blind study with the new antidepressant viloxazine compared to imipramine in 50 inpatients [translated]	50 (25 viloxazine) [4 weeks, compared to imipramine]	Depression [inpatient]	150–300 mg	Lower withdrawal rate (n = 2) compared to imipramine (n = 7)
Frank, UK, date unknownb	Double-blind study of low doses of viloxazine vs. placebo in mild depression in general practice	63 (30 viloxazine) [2 weeks]	Mild depression [outpatient]	100 mg [50 mg bid]	Significantly higher withdrawal rate because of AEs than placebo, lower AEs than placebo in completers

AEs adverse events, bid twice a day, qid four times a day, tid three times a day

^aTolerability commentary compiled per available safety statements in acquired study reports

^bData are from acquired unpublished study reports of trials conducted prior to 1976