A randomized, open-label comparison of venlafaxine and fluoxetine in depressed outpatients

• Published in: Clinical therapeutics Vol. 20; no. 3; pp. 467 - 476
• Main Authors: Diaz-Martinez, Alejandro, Benassinni, Oscar, Ontiveros, Alfonso, Gonzalez, Salvador, Salin, Rafael, Basquedano, Gaspar, Martinez, Rene A.
• Format: Journal Article
• Language: English
• Published: Belle Mead, NJ EM Inc USA 01.05.1998; Excerpta Medica
• Subjects: Adolescent; Adult; Antidepressive Agents, Second-Generation - adverse effects; Antidepressive Agents, Second-Generation - therapeutic use; Biological and medical sciences; clinical study; Cyclohexanols - adverse effects; Cyclohexanols - therapeutic use; Depressive Disorder - drug therapy; Depressive Disorder - psychology; Female; fluoxetine; Fluoxetine - adverse effects; Fluoxetine - therapeutic use; Humans; major depression; Male; Medical sciences; Middle Aged; Neuropharmacology; Outpatients; Pharmacology. Drug treatments; Prospective Studies; Psychiatric Status Rating Scales; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease); Psychology. Psychoanalysis. Psychiatry; Psychopharmacology; venlafaxine; Venlafaxine Hydrochloride; clinical study; venlafaxine; fluoxetine; major depression; Mood disorder; Human; Serotonin; Fluoxetine; Psychotropic; Toxicity; Treatment efficiency; Depression; Reuptake inhibitor; Dose activity relation; Chemotherapy; Treatment; Antidepressant agent; Venlafaxine; Norepinephrine; Ambulatory; Comparative study
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(98)80056-8

In this randomized, open-label, 8-week comparative study, the efficacy and safety of venlafaxine and fluoxetine were assessed in outpatients with major depression. One hundred forty-five patients were assigned to receive venlafaxine 37.5 mg twice daily or fluoxetine 20 mg once daily. On day 15, if clinically indicated to improve patient response, the dosage could be increased at the investigator's discretion to venlafaxine 75 mg twice daily or fluoxetine 40 mg once daily. One hundred forty-five patients were evaluated for safety and 110, for efficacy. The mean age was 37 years, and 70% of the patients were female. In both treatment groups, mean scores on the Hamilton Depression Rating Scale decreased significantly between baseline (27.8, venlafaxine; 29.2, fluoxetine) and the end of the study (8.7, venlafaxine; 8.2, fluoxetine). Similarly, mean scores on the Montgomery-Asberg Depression Rating Scale decreased significantly between baseline (31.4, venlafaxine; 31.6, fluoxetine) and the end of the study (8.3, venlafaxine; 7.6, fluoxetine). In venlafaxine patients, the most common adverse events were nausea (44.3%), headache (40.0%), insomnia (31.4%), dizziness (30.0%), and dry mouth (22.9%); in fluoxetine patients, they were headache (32.0%), nausea (28.0%), insomnia (24.0%), anxiety (21.3%), sleepiness (20.0%), and generalized tremor (20.0%). The results of this study indicate that venlafaxine is effective and well tolerated for the treatment of major depression at doses of 37.5 or 75 mg twice daily and not significantly different from fluoxetine 20 or 40 mg once daily.