Professor Michael Berk
University of Melbourne, VIC
Mental Health Pilot Study 2010
Professor Michael Berk is currently appointed to the Chair of Psychiatry for Barwon Health and The Geelong Clinic at The University of Melbourne. He also is an Honorary Professorial Research fellow at the Mental Health Research Institute, and leads the first episode bipolar program at Orygen Youth Health. He is Chairman of the International Society of Bipolar Disorders, and Vice Chairman of the Australasian Society of Bipolar Disorders. He has published over 300 papers on a range of topics with his research interests focusing on mood and psychotic disorders, particularly bipolar disorder and depression. His greatest contribution to the field is in the discovery and implementation of novel therapies. He has published 17 self-initiated, non-industry randomised controlled trials, predominantly in bipolar disorder. He is a committee member of both the Collegium Internationale Psychopharmacologicum and World Federation of Societies of Biological Psychiatry is a member of a number of international advisory boards. He was the founding editor of The Journal of Depression and Anxiety, has served as guest editor or is on the editorial board of 12 other journals as well as being a reviewer of 30 journals.
He is the recipient of a number of grants, including a NHMRC CCRE and 3 project grants, a two Beyondblue grants and two Stanley Medical Research Institute awards. He is regularly invited as a guest speaker at international meetings. In 2008, he was awarded the Australasian Society of Psychiatric Research Eli Lilly Oration, the Pathcare Smart Geelong Research and Learning Expo Health and Lifestyle award and the G Force Recruitment Researcher Of The Year award for this work. Since relocating to Australia in 2001, he has established a new research unit at Barwon Health, which now has 15 researchers and 6 students engaged in 33 projects, multiple, local national and international collaborations, as well as heading a clinical Professorial Unit at the Geelong Clinic.
SUMMARY OF PROJECT:
Efficacy of N-acetylcysteine in Autism: A double-blind, placebo-controlled randomised trial
Background
Autism is a severe illness characterized by impairments in communication, reciprocal social interactions and stereotyped patterns of interest or behaviours. There are few treatment options available to treat children with autism, and current treatment options are associated with limited results. There is an urgent need for the development of new treatments, which may significantly improve the lives of children with autism and their carers.
Recent there has been interest in finding out more about a link between autism and increased oxidative stress, which may contribute to the development and symptoms of this disease. Consequences of oxidative stress include purkinje cell loss, altered purkinje cell physiology, altered brain volume, and a link with heavy metal toxicity, all of which have also been linked to autism.
Oxidative stress can be reversed using strategies to decrease the levels of reactive oxygen species in the body or by boosting defences. N-acetylcysteine (NAC) is a naturally occurring antioxidant. NAC is an ideal therapeutic candidate as it increases brain glutathione after oral administration, and is better tolerated than other agents used to treat autism. Our group has successfully used NAC as add-on therapy in the treatment of schizophrenia and bipolar disorder, where significant improvements in core symptoms, quality of life and functioning were achieved. NAC has also been successfully trialled in Alzheimer’s disease.
Objectives Of The Research
1g daily of NAC or placebo will be given to recently diagnosed young children with autism. The study is a 26-week randomised, placebo-controlled trial. A range of outcome measures will be included. The researchers hope that NAC treatment will be associated with better outcomes for people with autism.
Method
Study Group: Twenty recently diagnosed patients with autism aged 3-6 years.
Recruitment Procedure: Children with recently diagnosed autism presenting to Barwon Health, Geelong Australia, and the Monash Centre for Autism Research Education and Service (CARES), Melbourne, Australia, will be selected. All will be treated as per standard clinical practice, and NAC (N=10) or placebo (N=10) will be added to this procedure. Their guardians or parents will sign informed written consent.
Dosage strategy:At baseline, all individual will receive one capsule of 500mg NAC or placebo twice daily.
Outcomes and Significance
Autism is a severe disorder. There are few pharmacological options in this disorder, and treatment outcomes are sub-optimal in most individuals. Currently available options largely target secondary symptoms such as disruptive behaviour. This study is an exciting opportunity to study a novel, tolerable, affordable, available and practical adjunctive therapy with a solid theoretical foundation to its use. Research has already demonstrated changes in oxidative markers in autism. Positive results from studies of NAC to treat schizophrenia and bipolar disorder present a compelling indication to examine the role of NAC in autism. This is augmented by the established excellent tolerability profile of NAC, together with its appeal as a “natural” option. In addition to establishing a novel treatment, this study will demonstrate new insights into the role of oxidative stress in of autism.