A meta-analysis of eight randomized, double-blind, controlled clinical trials of mirtazapine for the treatment of patients with major depression and symptoms of anxiety.

BACKGROUND: Patients diagnosed with major depression and prominent symptoms of anxiety often have a poor prognosis for recovery. A meta-analysis was performed to assess the efficacy of mirtazapine in comparison with placebo and amitriptyline for the relief of anxiety/agitation or anxiety/somatization in patients with major depressive illness.

METHOD: A meta-analysis of eight randomized, double-blind, placebo-controlled clinical trials was conducted for 161 mirtazapine-treated and 132 placebo-treated patients with a DSM-III diagnosis of major depression, baseline Hamilton Rating Scale for Depression (HAM-D) scores > or = 18, and a baseline score > or = 6 for the sum of HAM-D items 9, 10, and 11 (anxiety/agitation). Four of the clinical trials included an amitriptyline control group (N = 92).

RESULTS: Mirtazapine-treated patients demonstrated a statistically significant (p < or = .05) reduction in the sum of HAM-D items 9, 10, and 11 (anxiety/agitation) compared with placebo-treated patients at Weeks 1, 2, 4, and 6 and at the endpoint. There was no statistically significant difference between the mirtazapine- and amitriptyline-treated patients at Weeks 1, 3, 4, 5, and 6 and at the endpoint. Similar results were found for the analysis of the mean of HAM-D items 10, 11, 12, 13, 15, 17 (anxiety/somatization or HAM-D Factor Score I) using all treated patients with a post-baseline evaluation in all 8 studies. Mirtazapine-treated patients demonstrated a statistically significant (p < or = .03) greater reduction at Weeks 1-6 compared with placebo, and improvement in the mirtazapine group was comparable to improvement in the amitriptyline group at Weeks 1-6.

CONCLUSION: In this meta-analysis of eight randomized, double-blind, controlled clinical trials, mirtazapine was found to be superior to placebo and comparable to amitriptyline for the treatment of patients with major depression with symptoms of anxiety/agitation or anxiety/somatization.