A double-blind placebo-controlled study of Org 3770 in depressed outpatients.
90 patients between 18 and 65 years, with a DSM-III diagnosis of moderate or severe major depressive episode, were randomized to 6 weeks of treatment with Org 3770 or placebo in a double-blind trial. On main efficacy parameters, the 17-item HAMD, MADRS and CGI, Org 3770 was significantly superior to placebo (P < or = 0.05) in weeks 1-4 and at endpoint and recommended as continuation treatment to significantly more patients. The tolerability of Org 3770 was good: the only significant differences as compared with placebo were in the incidences of somnolence and increased appetite. The results show that Org 3770 is an effective and well-tolerated drug for the treatment of major depressive disorder.
Claghorn
J L
JL
Claghorn Lesem Research Clinic, Bellaire, TX 77401, USA.
Lesem
M D
MD
D000293:Adolescent; D000328:Adult; D000368:Aged; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008803:Mianserin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D000078785:Mirtazapine; D010555:Personality Inventory; D016896:Treatment Outcome
D000929:Antidepressive Agents, Tricyclic; D008803:Mianserin; D000078785:Mirtazapine