section name header

Evidence summaries

Asenapine Versus Placebo for Schizophrenia

Asenapine might possibly provide an improvement in positive, negative, and depressive symptoms of schizophrenia, whilst minimising the risk of adverse effects, although the evidence is insufficient. Level of evidence: "D"

Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment, high loss to follow-up), imprecise results (few studies for comparison) and indirectness (short follow-up time).

Summary

A Cochrane review [Abstract] 1 included 6 studies with a total of 1835 subjects. Six weeks was a common trial length and the duration varied from 16 days (one study) to 52 weeks (one study). Asenapine resulted in a clinically important change in global state (RR 0.81, 95% CI 0.68 to 0.97; 1 RCT, n = 336) and mental state (RR 0.72, 95% CI 0.59 to 0.86; 1 RCT, n = 336) at short-term (up to 12 weeks). People receiving asenapine demonstrated significant reductions in negative symptoms (MD -1.10, 95% CI -2.29 to 0.09; 1 RCT, n = 336) at short-term. Individuals receiving asenapine demonstrated significantly fewer incidents of serious adverse effects (RR 0.29, 95% CI 0.14 to 0.63; 1 RCT, n = 386) at medium-term (13 to 26 weeks). There was no clear difference in people discontinuing the study for any reason between asenapine and placebo at short-term (RR 0.91, 95% CI 0.80 to 1.04, 5 RCTs, n = 1046). No trial reported data for extrapyramidal symptoms or costs.

Clinical comments

Note

Date of latest search:

References

  • Hay A, Byers A, Sereno M et al. Asenapine versus placebo for schizophrenia. Cochrane Database Syst Rev 2015;11():CD011458. [PubMed]

Primary/Secondary Keywords