Brief ReportsDoes Insight Affect the Efficacy of Antipsychotics in Acute Mania? An Individual Patient Data Regression Meta-AnalysisWelten, Carlijn C.M. MD*†; Koeter, Maarten W.J. PhD*; Wohlfarth, Tamar D. PhD†; Storosum, Jitschak G. MD, PhD*; van den Brink, Wim MD, PhD*; Gispen-de Wied, Christine C. MD, PhD†; Leufkens, Hubert G.M. PhD†; Denys, Damiaan A.J.P. MD, PhD*‡Author Information From the *Department of Psychiatry, Academic Medical Centre, University of Amsterdam, Amsterdam; †Medicines Evaluation Board, Utrecht; and ‡Netherlands Institute for Neuroscience, Royal Netherlands Academy of Arts and Sciences, Amsterdam, The Netherlands. Received May 7, 2015; accepted after revision October 13, 2015. Reprints: Carlijn C.M. Welten, MD, Department of Psychiatry, Academic Medical Centre, Room PA 2-179, Meibergdreef 9, 1105AZ, Amsterdam, The Netherlands (e-mail: [email protected]). Journal of Clinical Psychopharmacology: February 2016 - Volume 36 - Issue 1 - p 71-76 doi: 10.1097/JCP.0000000000000435 Buy Metrics Abstract Patients having an acute manic episode of bipolar disorder often lack insight into their condition. Because little is known about the possible effect of insight on treatment efficacy, we examined whether insight at the start of treatment affects the efficacy of antipsychotic treatment in patients with acute mania. We used individual patient data from 7 randomized, double-blind, placebo-controlled registration studies of 4 antipsychotics in patients with acute mania (N = 1904). Insight was measured with item 11 of the Young Mania Rating Scale (YMRS) at baseline and study endpoint 3 weeks later. Treatment outcome was defined by (a) mean change score, (b) response defined as 50% or more improvement on YMRS, and (c) remission defined as YMRS score less than 8 at study endpoint. We used multilevel mixed effect linear (or logistic) regression analyses of individual patient data to assess the interaction between baseline insight and treatment outcomes. At treatment initiation, 1207 (63.5%) patients had impaired or no insight into their condition. Level of insight significantly modified the efficacy of treatment by mean change score (P = 0.039), response rate (P = 0.033), and remission rate (P = 0.043), with greater improvement in patients with more impaired insight. We therefore recommend that patients experiencing acute mania should be treated immediately and not be delayed until patients regain insight. Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.