Comment: The quality of evidence is downgraded by inconsistency (heterogeneity in patients and outcomes), imprecise results (few trials for each comparison) and indirectness (short follow-up time)
A Cochrane review [Abstract] 1 included 9 studies with a total of 310 patients with schizophrenia. All studies compared mirtazapine adjunct with placebo adjunct and were of short-term duration (from one to 8 weeks). One trial (n=20) defined a reduction in the Scale for the Assessment of Negative Symptoms (SANS) overall score from baseline of at least 20% as no important response for negative symptoms. There was no difference between the two groups (RR 0.81, 95% CI 0.57 to 1.14; 1 RCT, n = 20). Clinically important change in overall mental state was reported by 2 trials (n=77), there was a favourable effect for mirtazapine (RR 0.69, 95% CI 0.51 to 0.92; 2 RCTs, n = 77). There was no difference for numbers of patients leaving the study early (RR 1.03, 95% CI 0.64 to 1.66, 9 RCTs, n = 310), or in global state Clinical Global Impressions Scale (CGI) severity scores (MD -0.10, 95% CI -0.68 to 0.48, 1 RCT, n = 39). A favourable effect for mirtazapine adjunct was found for the clinically important change in akathisia (RR 0.33, 95% CI 0.20 to 0.52, 2 RCTs, n = 86). Mirtazapine adjunct groups were associated with an increased risk of weight gain (RR 3.19, 95% CI 1.17 to 8.65, 4 RCTs, n = 127) and sedation/drowsiness (RR 1.64, 95% CI 1.01 to 2.68, 7 RCTs, n = 223).
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