Professor Michael Berk
University of Melbourne, VIC
Mental Health 2009 and 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:
The Efficacy of N-acetylcysteine as an Adjunctive Treatment in Unipolar Depression: A Double-blind, Randomised, Placebo-controlled Trial
This clinical trial in investigating the potential of an antioxidant treatment for the symptoms of major depression. Major depression is a relatively common illness affecting approximately one in five people over the course of their lifetime. While current therapies have been shown to be undeniably helpful in treating the symptoms of major depression there is still room to improve therapies for those who did not get optimal outcomes from conventional treatments.
It has been reported that there are changes in the levels of antioxidants in people with major depression. This may be causing increased oxidative stress in the brain. Oxidative stress is a term used to describe a situation of either decreased antioxidant levels or increased levels of free radicals (molecules which have additional oxygen particles which may be damaging to cells). When oxidative stress is present there is the potential for brain cells (neurons) to be damaged and no longer function correctly. It is believed that this situation may be involved in the symptoms of major depression. The most common antioxidant in the brain is glutathione. It is believed that the glutathione system may be altered in major depression. Based on this theory, we are proposing to conduct a clinical trial using a treatment that may increase the levels of brain glutathione and thereby potentially reduce the symptoms of major depression.
This clinical trial will be conducted using N-acetyl cysteine (NAC). NAC is a modified version of the amino acid, cysteine. In this form it is more efficiently taken up by the brain. Cysteine is a precursor for the production of glutathione. By giving trial participants NAC we believe we may be able to increase the levels of glutathione in the brain. This trial will be placebo controlled where half of the participants will receive NAC and the other half a ‘dummy drug’, which contains starch. Importantly, all participants will stay on their current treatments while taking the trial medication. Improvements are expected over those found with their current treatment and this also means that participants who are taking the placebo aren’t disadvantaged or untreated during the trial period.
Each participant will be required to take part in the trial for a total of 4 months. For the first three months they will take the trial medication (either NAC or placebo). During this time they will come in for five interviews where experienced research staff will ask them questions about their symptoms and general functioning. The participants’ answers will be documented on validated rating scales commonly used to investigate the symptoms of major depression in research trials. Four weeks after the end of the trial period, participants will be requested to take part in a final interview to assess their symptoms following the withdrawal of the trial medication.
At the completion of the trial the data will be analysed and comparisons made between the NAC and placebo groups. This will determine if NAC treatment has been beneficial to people while on the trial. Additionally, comparisons will be made between the end of the trial period and the final visit. This will reveal if any potential benefits of NAC treatment have lessened since the withdrawal of the NAC.
This clinical trial will not only assist in providing a potential new target for future therapies but may also further our understanding of the underlying causes of the symptoms of major depression. Ultimately, this trial aims to assist in providing better outcomes for people who have major depression so that they can live their lives to the fullest.