Randomized double-blind study of fluvoxamine and maprotiline in treatment of depression.

In a six-week double-blind randomized trial, preceded by a one-week period of single-blind placebo treatment, the efficacy and the side-effects of fluvoxamine (100-300 mg/d) (n = 24) and maprotiline (50-150 mg/d) (n = 24) were compared in moderately depressed outpatients with DSM-III Major Depression (n = 22) or Dysthymic Disorder (n = 26). Efficacy was measured by means of the Hamilton Depression Rating Scale, the Zung Depression Selfrating Scale, and a Clinical Global Impression of Severity Scale. Side-effects were evaluated by an Adverse Event Inventory and a Psychosomatic Symptom Scale. A statistically significant improvement was achieved in both treatment groups but success rates were modest: in both groups, 29% of the patients achieved a clinically significant improvement after six weeks of treatment. After six weeks of treatment, no difference in efficacy was found between fluvoxamine and maprotiline. Nausea was the most common complaint in the fluvoxamine group, while in the maprotiline group, it was dry mouth and constipation. One maprotiline-treated patient developed a convulsive attack.

RCT Entities:   Population Interventions Outcomes