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- Title
Effect Size and Blinding in Lumateperone Trial-Reply.
- Authors
Correll, Christoph U.; Lakkis, Hassan D.; Vanover, Kimberly E.
- Abstract
Comment & Response B In Reply b We thank Gouse et al for raising 2 points regarding the efficacy and safety of lumateperone.[1] The effect size of -0.30 for lumateperone, 42 mg, on the Positive and Negative Syndrome Scale total score is in the range of other recently approved antipsychotics: brexpiprazole (-0.26), cariprazine (-0.34), and lurasidone (-0.36).[2] More recent trials of antipsychotics[[2]] had higher placebo responses and therefore smaller effect size but not necessarily smaller improvement, which is what the patient and clinician would detect. Because a higher proportion of patients in the placebo group than the lumateperone group discontinued treatment owing to lack of efficacy, we conducted post hoc analyses based on the assumption that the missing data were missing not at random. The treatment difference between lumateperone, 42 mg, and placebo based on the comparison of medians (-6.5; unadjusted I P i =.004) or means in the better-half subset (-6.2; unadjusted I P i =.004) was larger than the mean difference for the primary MMRM.
- Subjects
BLIND experiment; TREATMENT effectiveness; DRUG therapy for schizophrenia; ANTIPSYCHOTIC agents
- Publication
JAMA Psychiatry, 2020, Vol 77, Issue 6, p651
- ISSN
2168-622X
- Publication type
letter
- DOI
10.1001/jamapsychiatry.2020.0613