M57. Gastrointestinal Disease Impact on Antipsychotic Induced Weight Gain in Schizophrenia: Analysis of Randomized Controlled Trials

Abstract

Background: Although atypical antipsychotics have been effective at treating psychotic symptoms, secondary effects including weight gain contribute to the development and exacerbation of chronic disease leading to poor outcomes and attenuated lifespan in schizophrenia. The aim of this study was to estimate the overall incidence of gastrointestinal disorders for people with schizophrenia actively participating in antipsychotic medication trials in order to determine the relationship between gastrointestinal disorders and antipsychotic induced weight gain.

Methods: Randomized, double­blind, placebo and active comparator antipsychotic monotherapy trial data from the NIMH CATIE Schizophrenia Distribution 15 has been obtained for subsequent analyses as part of the Open Translational Science in Schizophrenia (OPTICS) project. The participants included in these initial analyses were individuals diagnosed with schizophrenia or schizoaffective disorder from the CATIE phase 1 trials with baseline and post treatment outcome measures available. The primary outcome measure for these analyses was change in weight after accounting for sociodemographic factors.

Results: Preliminary analyses suggest that 7.5% of the study participants spontaneously reported a gastrointestinal (GI) disorder before study randomization. Of those with a GI disorder, 70.9% reported experiencing gastro-oesophogeal reflux disease (GERD), followed by 7.9% reporting history of irritable bowel syndrome (IBS). The overall incidence of GI disorder remained the same at the end of the Phase 1/1a. As previously reported, there was a significant increase in weight gain at the end of Phase 1, P = .014. Gastrointestinal disease did not independently contribute to antipsychotic induced weight gain, P = .891.

Conclusion: Further examination with additional schizophrenia case-control data sets will help determine whether there is increased prevalence of individual GI disorders in schizophrenia. Inclusion of additional antipsychotic medication trials are necessary to replicate and determine the generalizability of these findings. Future studies that include systematic assessment of gastrointestinal diseases and medical records that corroborate incidence of gastrointestinal disorders, will also be needed to confirm these preliminary findings.