|
A 12-week study utilizing Effexor XR doses in a range 75 to 150 mg/ day (mean dose for completers was 136 mg/ day) and an 8-week study utilizing Effexor XR doses in a range 75 to 225 mg/ day (mean dose for completers was 177 mg/ day) both demonstrated superiority of Effexor XR over placebo on the HAM-D total score, HAM-D Depressed Mood Item, the MADRS total score, the Clinical Global Impressions (CGI) Severity of Illness item, and the CGI Global Improvement item. In both studies, Effexor XR was also significantly better than placebo for certain factors of the HAM-D, including the anxiety/ somatization factor, the cognitive disturbance factor, and the retardation factor, as well as for the psychic anxiety score. A 4-week study of inpatients meeting DSM-III-R criteria for major depressive disorder with melancholia utilizing Effexor (the immediate release form of venlafaxine) in a range of 150 to 375 mg/ day (t. i. d. schedule) demonstrated superiority of Effexor over placebo. The mean
dose in completers was 350 mg/ day. Examination of gender subsets of the population studied did not reveal any differential responsiveness on the basis of gender. In one longer-term study, outpatients meeting DSM-IV criteria for major depressive disorder who had responded during an 8-week open trial on Effexor XR (75, 150, or 225 mg, qAM) were randomized to continuation of their same Effexor XR dose or to placebo, for up to 26 weeks of observation for relapse. Response during the open phase was defined as a CGI Severity of Illness item score of 3 and a HAM-D-21 total score of 10 at the day 56 evaluation. Relapse during the double-blind phase was defined as follows: Text Continues Below
(1) a reappearance of major depressive disorder as defined by DSM-IV criteria and a CGI Severity of Illness item score of 4 (moderately ill), Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
