Clinical Discovery Project
Michael Berk
The Barwon Psychiatric Research Unit
and the Mental Health Research Institute
are collaborating to investigate oxidative
stress and psychiatric illnesses.
At present, clinical trials investigating antioxidant
treatments for psychiatric illnesses are
being undertaken, as well as partnerships
on laboratory-based projects aimed at
clarifying the underlying mechanisms.
The Barwon Psychiatric Research Unit encompasses
a broad range of psychiatric research. These include
epidemiology studies looking primarily at prevention
of psychiatric disorders, diet, and the psychological
somatic interface. There is an active clinical trials unit,
focusing on oxidative biology and internet-based
therapies. Drug safety is a further focus. The unit aims
to further understand the underlying pathology of mental
illness and to assist in the discovery of better treatments
for people with these illnesses.
The team has published many papers and received
several awards, including 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.
Antioxidant trials
These trials are investigating the benefits of the
antioxidant N-acetyl cysteine (NAC) on the symptoms
of psychiatric illness. A clinical trial investigating
antioxidant treatments and bipolar disorder has been
completed with two additional trials underway.
One is investigating bipolar disorder using a larger trial with
an alternative design and has recruited a total of 155
participants. The second is investigating depression
and continues to recruit participants.
Two major publications have resulted from earlier trials
investigating NAC as an adjunct therapy in schizophrenia
and bipolar disorder. These showed that NAC (in addition
to participants’ usual treatment) was beneficial over
placebo in treating the symptoms of these illnesses.
In conjunction with these trials, magnetic resonance
spectroscopy is being used to investigate biochemical
markers following NAC treatment. The unit has also
formed a collaboration with Brian Dean (from the Rebecca
L Cooper Laboratory) and a team in Canada to investigate
oxidative markers in postmortem brain tissue.
NAC in bipolar disorder
This clinical trial is investigating the benefits of NAC
in treating the depressive phase of bipolar disorder.
The trial is a maintenance-designed trial where all
participants are given NAC for two months.
Following
this, participants are randomised into either continuing
NAC treatment or receiving a placebo. Participants
continue on the trial for a further six months and
interviews are conducted regularly to assess the
changes in participant’s symptoms. The trial of NAC
is being conducted in addition to the usual treatment
participants are undergoing. Recruitment for this study
has been completed and there are 31 participants
currently participating in the trial.
NAC in major depression
This clinical trial is using a double blind, randomised
design to investigate the benefits of NAC treatment
compared with placebo in people with unipolar (major)
depression. As with the bipolar disorder trial, participants
are maintained on their usual treatment and given either
NAC or placebo in addition to that. Participants are asked
to take trial medication for three months. Over this period,
participants are interviewed several times to determine
changes in their symptoms. Four weeks following the
end of the trial medication, a follow-up visit is conducted
to establish how participants’ symptoms have changed
following the discontinuation of NAC. The recruitment
target for this trial is 120 participants, of which 98 have
been recruited to date.
Funding
The Stanley Medical Research Institute has provided a
research grant to undertake the NAC in bipolar disorder
trial. A grant has also been provided from the Rotary
Foundation to assist in the funding of the depression trial.
Future directions
The unit is developing trials of the use of NAC in smoking cessation, and is examining trials in early intervention in psychosis. In addition, a series of projects examining the
biological foundation of the activity of NAC are planned.
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