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. The incidence of nausea was highest during the first 2 weeks with a low likelihood of developing nausea thereafter. The most common treatment-emergent adverse event with venlafaxine XR was nausea. Venlafaxine XR exhibited superiority (p < 0.05) over venlafaxine IR at week 12 for all efficacy variables. 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 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. Two hundred seventy-eight patients were evaluated for efficacy. The antidepressant venlafaxine extended release has demonstrated efficacy for treating both MDD (Thase et al., 2017) and anxiety disorders in double-blind, placebo-controlled clinical trials (Rickels et al., 2000 Davidson et al., 1999 Allgulander et al., 2004b) and is approved for the treatment of generalized anxiety disorder (GAD), social anxiety disorder, and panic disorder in addition to MDD (Effexor package insert, 2017). 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. If the response was inadequate after 2 weeks of treatment, the dosage of venlafaxine XR or IR could be increased to 150 mg daily. 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. 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).
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