Placebo response in antipsychotic trials of patients with acute mania

Abstract We examined the role of placebo response in acute mania trials. Specifically, whether placebo response: (1) predicts treatment effect, (2) can be predicted by patient and study characteristics, and (3) can be predicted by a parsimonious model. We performed a meta-analysis of individual pati...

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Published in:European neuropsychopharmacology 2015-07, Vol.25 (7), p.1018-1026
Main Authors: Welten, C.C.M, Koeter, M.W.J, Wohlfarth, T, Storosum, J.G, van den Brink, W, Gispen-de Wied, C.C, Leufkens, H.G.M, Denys, D.A.J.P
Format: Article
Language:English
Subjects:
Antipsychotics
Bipolar mania
Internal Medicine
Placebo response
Predictors
Psychiatry
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Summary:Abstract We examined the role of placebo response in acute mania trials. Specifically, whether placebo response: (1) predicts treatment effect, (2) can be predicted by patient and study characteristics, and (3) can be predicted by a parsimonious model. We performed a meta-analysis of individual patient data from 10 registration studies ( n =1019) for the indication acute manic episode of bipolar disorder. We assessed the effect of 14 determinants on placebo response. Primary outcome measures were mean symptom change score (MCS) on the Young Mania Rating Scale (YMRS) and response rate (RR), defined as ≥50% YMRS symptom improvement from baseline to endpoint. The overall placebo response was 8.5 points improvement on the YMRS (=27.9%) with a RR of 32.8%. Placebo response was significantly associated with the overall treatment response. Five determinants significantly ( p
ISSN:0924-977X
1873-7862
DOI:10.1016/j.euroneuro.2015.03.010