Clin Psychopharmacol Neurosci 2019; 17(2): 297-307  
Protocol and Rationale: A 24-week Double-blind, Randomized, Placebo Controlled Trial of the Efficacy of Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia
Alyna Turner1,2,3, John J. McGrath4,5,6, Olivia M. Dean1,3,7, Seetal Dodd1,3,8, Andrea Baker4, Susan M. Cotton8,9, James G. Scott4,10,11, Bianca E. Kavanagh1, Melanie M. Ashton1,7,12, Adam J. Walker1, Ellie Brown1,8,9, Michael Berk1,3,7,9
1IMPACT Strategic Research Centre, School of Medicine, Deakin University, Barwon Health, Geelong, 2Faculty of Health and Medicine, School of Medicine and Public Health, The University of Newcastle, Callaghan, 3Department of Psychiatry, University of Melbourne, Royal Melbourne Hospital, Parkville, 4Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, 5Queensland Brain Institute, University of Queensland, St. Lucia, Australia, 6National Centre for Register-based Research, School of Business and Social Sciences, Aarhus University, Aarhus, Denmark, 7Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, 8Centre for Youth Mental Health, The University of Melbourne, Parkville, 9Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, 10Metro North Mental Health Service, 11Faculty of Medicine, The University of Queensland, Herston, 12Department of Psychiatry, University of Melbourne, Professorial Unit, The Melbourne Clinic, Richmond, Australia
Correspondence to: Alyna Turner, PhD IMPACT Strategic Research Centre, P.O. Box 281, Geelong 3220, VIC, Australia
Tel: +61-3-4215-3313, Fax: +61-3-4215-3491 E-mail: a.turner@deakin.edu.au
ORCID: https://orcid.org/0000-0001-7389-2546
Received: September 7, 2018; Revised: October 31, 2018; Accepted: November 1, 2018; Published online: May 31, 2019.
© The Korean College of Neuropsychopharmacology. All rights reserved.

This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Objective: Garcinia mangostana Linn., commonly known as mangosteen, is a tropical fruit with a thick pericarp rind containing bioactive compounds that may be beneficial as an adjunctive treatment for schizophrenia. The biological underpinnings of schizophrenia are believed to involve altered neurotransmission, inflammation, redox systems, mitochondrial dysfunction, and neurogenesis. Mangosteen pericarp contains xanthones which may target these biological pathways and improve symptoms; this is supported by preclinical evidence. Here we outline the protocol for a double- blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp (1,000 mg/day), compared to placebo, in the treatment of schizophrenia.
Methods: We aim to recruit 150 participants across two sites (Geelong and Brisbane). Participants diagnosed with schizophrenia or schizoaffective disorder will be randomized to receive 24 weeks of either adjunctive 1,000 mg/day of mangosteen pericarp or matched placebo, in addition to their usual treatment. The primary outcome measure is mean change in the Positive and Negative Symptom Scale (total score) over the 24 weeks. Secondary outcomes include positive and negative symptoms, general psychopathology, clinical global severity and improvement, depressive symptoms, life satisfaction, functioning, participants reported overall improvement, substance use, cognition, safety and biological data. A 4-week post treatment interview at week 28 will explore post-discontinuations effects.
Results: Ethical and governance approvals were gained and the trial commenced.
Conclusion: A positive finding in this study has the potential to provide a new adjunctive treatment option for people with schizophrenia and schizoaffective disorder. It may also lead to a greater understanding of the pathophysiology of the disorder.
Keywords: Mangosteen; Garcinia mangostana Linn.; Schizophrenia; Psychotic disorder; Treatment clinical trial; Oxidative stress.


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