Treatment Trials

MAPrc researchers regularly seek people who have experience with mental illness, as well as those who do not, for participation in research projects and treatment trials.  See the drop-down menu above (under Treatment Trials) for details of current projects requiring research participants.

What is involved in participating will depend on the project, but it might involve one or more of the following:

Any personal information provided, and the record of participation, is treated as private health information and kept confidential.

All MAPrc studies have been approved, and are governed by, the Alfred Hospital Ethics Committee.

If you would like to forward a general expression of interest in participating in any of our research projects, please contact our centre on +61 (0)3 9076 6564 or email maprc@monash.edu

 

Complex Trauma Disorder (Borderline Personality Disorder)

 

Current treatment trials for Complex Trauma Disorder:

The Alison Project: understanding Complex Trauma Disorder and the role of Memantine

 

 

Resources for Complex Trauma Disorder:

1. How To Treat: Borderline Personality Disorder (Australian Doctor). This article was originally published by Australian Doctor. To see other articles like this click here.
 
 
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Dementia Clinical Trials

 

Alzheimer’s clinical trials

The clinical trials unit at Caulfield Hospital specialises in new treatments for Alzheimer’s disease.

Our Alzheimer's trials

Our team consists of doctors, nurses, neuropsychologists, and clinical trials coordinators with expertise in clinical trials for people with cognitive problems, including various types of dementia and neurodegenerative disorders.

Our main focus is on new medications for Alzheimer’s disease, both disease modifying drugs and symptomatic therapies. There are many treatments under development and we are usually recruiting interested patients into new studies.

Accessing Alzheimer's clinical trials

In order to be eligible to enter a clinical trial, participants need to have a formal diagnosis of Alzheimer’s disease or mild cognitive impairment due to Alzheimer’s. The diagnosis is usually made by a specialist, often a geriatrician, psychogeriatrician, neurologist or psychiatrist. Our service does not provide diagnostic cognitive assessments.

If you would like to know more about current clinical trials please contact us:

Members of the MAPrc Caulfield Dementia Clinical Trials Team

Depression

MAPrc’s researchers are currently working on a number of projects investigating new diagnostic and treatment methods for people experiencing depression

The following projects are currently recruiting participants. Please contact us if you wish to receive information or take part in a project.


Nitrous Oxide treatment for Major Depressive Disorder (MDD)

Clinical trial of Nitrous Oxide (laughing gas) treatment for the treatment of MDD has commenced at MAPrc in December 2018. To take part in the study you must be at least 18 years old, be experiencing MDD without psychosis, and have been stable on depression medication for at least 4 weeks. For further details, please contact Ms Alisa Turbic on 9076 6591 or email maprc-n2o-study@monash.edu

  
Tibolone and Escitalopram in Perimenopausal Depression
Clinical trials of a hormone treatment called Tibolone, for the treatment of depression in peri and post menopause. To take part in this study you must be physically well, aged 45-65 be experiencing depression and able to give informed consent. For further details click here or contact Caitlin Bleeker on 9076 6564 or email maprc.wmhresearch@monash.edu

 
Transcranial magnetic stimulation (TMS) for Depression
TMS uses magnetic pulses to change activity in the areas of the brain thought to be related to this illness, and is being investigated as an alternative treatment for people, who have not responded to antidepressant medication. For further information click here or contact the TMS team on 9076 8538 or email tms-enquiry@monash.edu

 
Deep Brain Stimulation for Depression
Deep Brain Stimulation involves the precise implantation of very small electrodes into specific areas of the brain, in an attempt to change activity in those and related areas and improve the symptoms of very severe, treatment-resistant depression.
 
As DBS is considered a treatment of last resort, only individuals who have trialled all less invasive antidepressant treatments and remained severely depressed can be considered for the procedure, This means having trialled multiple medications from all antidepressant drug classes, combinations of antidepressant medications, cognitive behavioural therapy, transcranial magnetic stimulation and extensive electroconvulsive therapy (ECT).
 
If you wish to be considered for the program, and you have tried all of the treatments listed above, you can have your psychiatrist send a detailed referral letter to Prof. Paul Fitzgerald at paul.fitzgerald@monash.edu

 
EVestG (ElectrovestibuloGraphy)
A new technique, EVestG (ElectrovestibuloGraphy) in being investigated as a possible objective method for diagnosing participants with depression. For further information click here or contact MAPrc on 9076 6564 or email maprc@monash.edu 

   
Mood and Oral Contraceptives 
An observational study of women taking / not taking hormonal contraception (i.e. COCP, POP, Implanon, DMPA) exploring current mood & risk and resistance factors for adverse mood change. To take part in this study you must be a female 18 years of age or older, able to give informed consent and not currently pregnant, breast-feeding or menopausal. For further information click here or contact Natalie Thomas on 9076 5033 or email natalie.thomas@monash.edu 

 
National Register of Antipsychotic Medication in Pregnancy (NRAMP)
An observational study aimed at evaluating the safety of antipsychotic medications for mothers and babies during pregnancy. NRAMP aims to develop evidence-based guidelines for the best use and effect of antipsychotic medications during pregnancy, birth, and postnatal phase, thereby assisting healthcare professionals and women with mental illness to make informed decisions about appropriate treatment options and encourage safer outcomes for mother and baby. For further information or to find out how you can participate in the study click here or contact Ms Alisa Turbic 9076 6591 or email maprc-nramp@monash.edu

 
 
 

 

 

 

Evaluation of the Antidepressant Effects of Nitrous Oxide in People with Major Depressive Disorder

 

Evaluation of the Antidepressant Effects of Nitrous Oxide in People with Major Depressive Disorder


Background:

Major depressive disorder (MDD) is a very common disease, with a lifetime prevalence of 15% and an annual incidence of about 7%. Nearly one-third of patients with MDD are severely depressed. MDD is associated with a two-fold increased risk of death compared with non-depressed individuals and is predicted to be the leading cause of disability in Western countries by 2030.

Although there is no definitive definition of treatment-resistant depression (TRD), an evolving consensus is failure to respond to a series of two adequate dose-duration antidepressant treatments. TRD is common, occurring in up to one-third of MDD patients, and is associated with a sense of ingrained hopelessness, high suicide risk, physical health decline, impairment in work, social and family life, and increased health care utilisation.


In collaboration with the Department of Anaesthesia at the Alfred Hospital, we are conducting a randomised trial to evaluate the antidepressant effects of nitrous oxide in people with major depressive disorder. This project will further evaluate these effects and identify the optimal dose and regimen to guide current practice, and to plan a future large pragmatic trial.


Aim:


Primary Aim: To determine whether a series of 4 x 60 min treatment sessions of inhaled nitrous oxide (once per week) has significant antidepressant activity.

 

Secondary Aims:

1.    To determine the acute (but post-drug elimination) effect of inhaled nitrous oxide at 24 hours after first treatment.

2.    To determine the persistent effect of inhaled nitrous oxide over a further 4 weeks’ post-treatment follow-up period (i.e. 7 weeks after initiation of study).

3.  To evaluate tolerability and safety profile of the 4-cycle treatments with nitrous oxide.

4.   To compare two doses (inhaled concentrations 25% and 50%) of nitrous oxide to establish whether the inhaled concentration is related to clinical response.

5.   To obtain pilot data to inform the design of a future large phase III trial.


Participants:

Adult (≥18 years, both sexes), with MDD diagnosis without psychosis are invited to take part in this study.


Methods:

This will be a randomised, patient- and assessor-blinded (double-blind), parallel-group, controlled trial, with patients randomly assigned (1:1) to nitrous oxide (Nitrous group) or oxygen-air mixture (FiO2 ≈0.3, Control group).  The Nitrous group will be further randomly assigned to either 50% nitrous oxide or 25% nitrous.

All patients will receive four treatment sessions, spaced at one week intervals (1st treatment = week 0), and will then be followed up for a further four weeks. Both nitrous oxide groups will be combined for the primary analysis. Ethics Committee approval and individual participant informed consent will be obtained before commencement of the trial.  

Project status

The study has began recruitment in December 2018. It is expected minimum 172 participants will be recruited across two sites.

For more information, please contact Ms Alisa Turbic via email at maprc-n2o-study@monash.edu or call 03 9076 6591

 

Fibromyalgia Study

 
Do you have a diagnosis of fibromyalgia?
 
The Monash Alfred Psychiatry Research Centre (MAPrc) at the Alfred Hospital is currently seeking volunteers for a clinical trial of a non-medication investigational treatment for fibromyalgia.
Theta Burst Stimulation (TBS) is a painless, safe, and non-invasive means of stimulating nerve cells in the brain. We are conducting this study to see whether we can reduce the symptoms of fibromyalgia.
To be involved, participants must be aged between 18 and 75 years and have a diagnosis of fibromyalgia. Participation will involve attending the Alfred for an initial 2 week period of daily (Monday-Friday) treatments followed by a 2 week period of 3 treatments per week. Each treatment appointment takes approximately 30 minutes.
 
For more information:
 
 - Download this flyer
 
 
 - Or contact Ms Freya Stockman
 
Email: freya.stockman@monash.edu
Phone: 03 9076 9896

Schizophrenia

 MAPrc’s researchers are currently working on a number of projects investigating new treatment methods for people experiencing schizophrenia

The following projects are currently recruiting participants. Please contact us if you wish to receive futher information or take part in a project.


 
 
Adjunctive SERM Hormone Treatment for Men and Women with Schizophrenia and Schizoaffective Disorder
Men and women who are 18 and over, with schizophrenia or schizoaffective disorder, are invited to take part in a 12-week adjunctive treatment study that is underway in Melbourne. Hormones are known to play a role in the expression of schizophrenia and related disorders. The Monash Alfred Psychiatry research centre is investigating whether a medication that targets hormone receptors in the brain, when taken in combination with regular antipsychotic medication, can better improve psychotic symptoms, mood and cognitive functioning. Participants will be reimbursed for their time and travel can be negotiated. For further details click here 
 
National Register for Antipsychotics in Pregnancy (NRAMP)
An observational study aimed at evaluating the safety of antipsychotic medications for mothers and babies during pregnancy. NRAMP aims to develop evidence-based guidelines for the best use and effect of antipsychotic medications during pregnancy, birth, and postnatal phase, thereby assisting healthcare professionals and women with mental illness to make informed decisions about appropriate treatment options and encourage safer outcomes for mother and baby.For further information or to find out how to take part in the study click here or contact Ms Alisa Turbic on 9076 6591 or email maprc-nramp@monash.edu 
 
EVestG (ElectrovestibuloGraphy)
We are currently trialling a new technique, EVestG (ElectrovestibuloGraphy) which is being investigated as a possible objective method for diagnosing participants with Schizophrenia.  For further information click here or contact MAPrc on 9076 6564 or email maprc@monash.edu 
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Bipolar Disorder

MAPrc’s researchers are currently working on a number of projects investigating new diagnostic and treatment methods for people experiencing bipolar disorders, the details of which can be found below

The following projects are currently recruiting participants.  Please contact us if you wish to receive futher information or to take part in a project.


 
EVestG (ElectrovestibuloGraphy)
We are currently trialling a new technique, EVestG (ElectrovestibuloGraphy) as an objective method for diagnosing participants with bipolar affective disorder. For further information click here or contact MAPrc on 9076 6564 or email maprc@monash.edu
 
 
National Register of Antipsychotic Medication in Pregnancy (NRAMP)
An observational study aimed at evaluating the safety of antipsychotic medications for mothers and babies during pregnancy. NRAMP aims to develop evidence-based guidelines for the best use and effect of antipsychotic medications during pregnancy, birth, and postnatal phase, thereby assisting healthcare professionals and women with mental illness to make informed decisions about appropriate treatment options and encourage safer outcomes for mother and baby. For further information or to find out how you can take part in the study click here or contact Ms Alisa Turbic on 9076 6591 or email maprc-nramp@monash.edu
 
 

 

Other Mental Illnesses

The following projects are currently recruiting participants. Please contact us if you wish to receive futher information or take part in a project.

Anxiety Disorders

MAPrc’s researchers are currently working on a number of projects investigating new treatment methods for people experiencing anxiety disorders, and the underlying brain mechanisms involved in the experience of anxiety symptoms.
 
Research Available at MAPrc: