title: Treatment of clozapine-associated obesity and diabetes with exenatide (CODEX) in adults with schizophrenia: study protocol for a pilot randomised controlled trial.
abstract: BACKGROUND
  Clozapine causes significant metabolic disturbances including obesity and type 2 diabetes. Recent evidence that reduced glucagon-like-peptide-1 (GLP-1) may contribute to aetiology of clozapine-associated metabolic dysregulation suggests a potential therapeutic role for GLP-1 agonists.
  
  
  METHODS
  This open-label, pilot randomised controlled trial evaluates the effect of exenatide in clozapine-treated obese adults who have schizophrenia, with or without poorly controlled diabetes. Sixty out-patients will be randomised to once weekly extended release exenatide or treatment as usual for 24 weeks.
  
  
  OBJECTIVE
  To evaluate the feasibility of larger studies regarding methodology, acceptability, tolerability and estimate efficacy for glycaemic control or weight loss. Secondary outcomes are psychosis severity and metabolic parameters.
  
  
  CONCLUSIONS
  This is the first trial investigating GLP-1 agonists for glycaemic control and weight loss in clozapine-treated patients with either diabetes or obesity. Clozapine-associated obesity and diabetes with exenatide (CODEX) will provide proof-of-concept empirical evidence addressing whether this novel treatment is practical and worthy of further investigation.
  
  
  BACKGROUND
  A.W.R. has received speaker honoraria and travel grants from AstraZeneca, BoehringerIngelheim, Eli Lilly, MSD, Novo Nordisk and Sanofi and has participated on advisory panels for MSD and Novo Nordisk.
  © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.
authors.affiliation: , BPharm (Hons) student, School of Pharmacy, University of Queensland, Brisbane, Australia.
authors.forename: Karla
authors.initials: K
authors.lastname: Mayfield
authors.affiliation: , MBBS, MPH, PhD, FRANZCP, Metro South Addiction and Mental Health Service, Princess Alexandra Hospital, Brisbane, Australia; School of Medicine, University of Queensland, Brisbane, Australia.
authors.forename: Dan
authors.initials: D
authors.lastname: Siskind
authors.affiliation: , BPharm, Cert Clin Phar, Dip Pharm Pract, Cert Psych Therap, School of Pharmacy, University of Queensland, Brisbane, Australia; Pharmacy Department, Princess Alexandra Hospital, Brisbane, Australia.
authors.forename: Karl
authors.initials: K
authors.lastname: Winckel
authors.affiliation: , BSc (Hons), PhD, MPH, School of Pharmacy, University of Queensland, Brisbane, Australia.
authors.forename: Samantha
authors.initials: S
authors.lastname: Hollingworth
authors.affiliation: , MD, PhD, FRANZCP, FRCPsych, FAFPHM, FFPH, FAChAM, School of Medicine, University of Queensland, Brisbane, Australia.
authors.forename: Steve
authors.initials: S
authors.lastname: Kisely
authors.affiliation: , MBBS, PhD, FRACP, School of Medicine, University of Queensland, Brisbane, Australia; Department of Diabetes and Endocrinology, Princess Alexandra Hospital, Brisbane, Australia.
authors.forename: Anthony W
authors.initials: AW
authors.lastname: Russell