Once-daily venlafaxine extended release (XR)
and venlafaxine immediate release (IR) in outpatients with major
depression. Venlafaxine XR 208 Study Group
Cunningham LA
Vine Street Clinical Research Center,
Springfield, Illinois 62701, USA.
Ann Clin Psychiatry 1997 Sep; 9(3):157-64
ABSTRACT
This was a randomized, double-blind,
placebo-controlled comparison of the efficacy and safety of once-daily
venlafaxine extended release (XR) and venlafaxine immediate release (IR).
Outpatients with DSM-III-R major depression were randomly assigned to
venlafaxine XR, 75 mg once daily, venlafaxine IR, 37.5 mg twice daily, or
placebo for a maximum of 12 weeks. If the response was inadequate after 2
weeks of treatment, the dosage of venlafaxine XR or IR could be increased to
150 mg daily. The primary efficacy variables were the 21-item Hamilton
Depression (HAM-D) Rating Scale total score and depressed mood item, the
Montgomery-Asberg Rating Scale (MADRS) total scores, and the Clinical Global
Impressions (CGI) severity scale. Two hundred seventy-eight patients were
evaluated for efficacy. Venlafaxine XR was significantly superior (p <
0.05) to placebo beginning at week 2 for the HAM-D, week 3 for the MADRS,
and week 4 for the CGI severity. Similarly, venlafaxine IR was significantly
superior (p < 0.05) to placebo beginning at week 2 on the HAM-D total and
depressed mood item, week 3 on the MADRS total, and week 6 on the CGI
severity scales. Venlafaxine XR exhibited superiority (p < 0.05) over
venlafaxine IR at week 12 for all efficacy variables. The most common
treatment-emergent adverse event with venlafaxine XR was nausea. The
incidence of nausea was highest during the first 2 weeks with a low
likelihood of developing nausea thereafter. The results of this study
indicate that venlafaxine XR is safe, effective, and well tolerated for the
treatment of major depression at once-daily doses ranging from 75 to 150 mg.
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