title: Treatment of antipsychotic-associated obesity with a GLP-1 receptor agonist--protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded intervention study: the TAO study protocol.
abstract: BACKGROUND
  Antipsychotic medication is widely associated with dysmetabolism including obesity and type 2 diabetes, cardiovascular-related diseases and early death. Obesity is considered the single most important risk factor for cardiovascular morbidity and mortality. Interventions against antipsychotic-associated obesity are limited and insufficient. Glucagon-like peptide-1 (GLP-1) receptor agonists are approved for the treatment of type 2 diabetes, but their bodyweight-lowering effects have also been recognised in patients with non-diabetes. The primary endpoint of this trial is weight loss after 3 months of treatment with a GLP-1 receptor agonist (exenatide once weekly) in patients with non-diabetic schizophrenia with antipsychotic-associated obesity. Secondary endpoints include physiological and metabolic measurements, various psychopathological and cognitive measures, and structural and functional brain MRI.
  
  
  METHODS
  40 obese patients with schizophrenia or schizoaffective disorder treated with antipsychotic drugs will be randomised to subcutaneous injection of exenatide once weekly (2 mg) or placebo for 3 months, adjunctive to their antipsychotic treatment.
  
  
  BACKGROUND
  The trial has been approved by the Danish Health and Medicines Authority, the National Committee on Health Research Ethics and the Danish Data Protection Agency. Trial participation presupposes theoral and written patient informed consent. An external, independent monitoring committee (Good Clinical Practice Unit at Copenhagen University Hospital) will monitor the study according to the GCP Guidelines. Trial data, including positive, negative and inconclusive results, will be presented at national and international scientific meetings and conferences. Papers will be submitted to peer-reviewed journals.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01794429; National Committee on Health Research Ethics project number: 36378; EudraCT nr: 2012-005404-17; The Danish Data Protection Agency project number: RHP-2012-027.
authors.affiliation: Center for Neuropsychiatric Schizophrenia Research and Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research, Psychiatric Center Glostrup, Glostrup Hospital, University of Copenhagen, Glostrup, Denmark.
authors.forename: Pelle L
authors.initials: PL
authors.lastname: Ishøy
authors.forename: Filip K
authors.initials: FK
authors.lastname: Knop
authors.forename: Brian V
authors.initials: BV
authors.lastname: Broberg
authors.forename: Lone
authors.initials: L
authors.lastname: Baandrup
authors.forename: Birgitte
authors.initials: B
authors.lastname: Fagerlund
authors.forename: Niklas R
authors.initials: NR
authors.lastname: Jørgensen
authors.forename: Ulrik B
authors.initials: UB
authors.lastname: Andersen
authors.forename: Egill
authors.initials: E
authors.lastname: Rostrup
authors.forename: Birte Y
authors.initials: BY
authors.lastname: Glenthøj
authors.forename: Bjørn H
authors.initials: BH
authors.lastname: Ebdrup
mesh_terms: D014150:Antipsychotic Agents / Q000009:adverse effects*; D002985:Clinical Protocols; D004311:Double-Blind Method; D000077270:Exenatide; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D009765:Obesity / Q000139:chemically induced* / Q000188:drug therapy*; D010455:Peptides / Q000627:therapeutic use*; D011446:Prospective Studies; D011618:Psychotic Disorders / Q000188:drug therapy; D012559:Schizophrenia / Q000188:drug therapy; D014688:Venoms / Q000627:therapeutic use*; D000097789:Glucagon-Like Peptide-1 Receptor Agonists
chemical_list: D014150:Antipsychotic Agents; D007004:Hypoglycemic Agents; D010455:Peptides; D014688:Venoms; D000077270:Exenatide; D000097789:Glucagon-Like Peptide-1 Receptor Agonists
keywords: Antipsychotic-associated obesity; Cardiovascular disease; Glucagon-like peptide-1 (GLP-1) receptor agonist; The metabolic syndrome