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

 

 


The Sarah Kelly Jones Scholarship in Complex Trauma Disorder:

In honour of Sarah Kelly Jones who lost her life to Complex Trauma Disorder earlier this year (2020), we are proud and privileged to establish the Sarah Kelly Jones Scholarship in complex trauma disorder to support a PhD candidate or medical doctor who will conduct focused research in this area to improve our understanding of this disorder and work to establish and promote new treatments for people living with CTD. With the support of the Jones family and many of Sarah's friends and supporters in Perth, W.A, an annual amount will be fund raised and donated to fund this scholarship. We look forward to awarding the scholarship in early 2021 once it has been established and to providing updates on the work conducted in this area. 

Sarah Kelly Jones


 

 

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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Depression

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

 

CLICK HERE TO FIND OUT MORE

 

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


Prax-114-202 Treatment trial for Perimenopausal Depression

 This is an industry sponsored clinical trial of a new class of medications that could help in the treatment of depression associated with menopause. To be eligible women must be experiencing current menopause symptoms, such as hot flushes, and have a diagnosis of major depression. Contact our friendly staff for more details and to find out if you might be eligible to participate. Email us at: participate.maprc@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
 

   
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 email maprc-nramp@monash.edu

 
 
 

 

 

 

PRAX-114 Research Study in Major Depressive Disorder

Background:

The Monash Alfred Psychiatry research centre (MAPrc), based at the Alfred Hospital is currently recruiting women suffering with peri-menopausal Major Depressive Disorder to participate in a clinical trial.

Major Depressive Disorder is a common but serious mood disorder. It causes severe symptoms that affect how you feel, think, and handle daily activities. Typically, it manifests as persistent feelings of sadness and loss of interest in normal day to day activities, often with symptoms such as disturbed sleeping, loss of interest in eating, or working.

The new treatment is called PRAX-114. PRAX-114 works by increasing the activity of GABA. GABA is a natural chemical in all brains that acts to decrease the function of some cells. One possible cause for depression is that GABA activity in the brain is too low.

MAPrc is currently recruiting for two parts of the study, Part A, and Part B. You can only participate in one of the two parts and your eligibility for either part will be determined by your study doctor.

Aim:

Primary Aim: To test the hypothesis that increasing GABA receptor neurotransmission, following an oral dose of PRAX-114, can provide therapeutic benefit to patients with MDD.

Secondary Aim: To assess the efficacy of PRAX-114 as an adjunctive antidepressant to standard of care in participants with MDD 

 

Participants:

Males and Females (between the ages of 18 and 65 years) with Major Depressive Disorder diagnosis without psychosis are invited to take part in this study.

Methods:

Before you begin the research study, we will give you detailed information about the research, study drug, and any other relevant information for participating int his research study. We encourage you to ask questions until you are sure that you fully understand the nature and the requirements.

This study has three parts, Part A, Part B, and Part C. You can only participate in one of the three parts, and your eligibility will be determined by your study doctor. At the moment, MAPrc are only recruiting participants for Part B and Part C.

  • Part B: Up to 24 participants (female with perimenopausal MDD), 14 oral doses of PRAX-114 up to 120 mg once every day (14 days outpatient). 


  • Part C: Up to 12 participants (male and female with MDD), 27 daily doses of PRAX-114 up to 120 mg once every day (27 days outpatient).

This study is open label which means that you will know which dose of study drug you are receiving, and the researchers will know as well. Part B will last about 6 weeks with a total of up to 6 visits. Part C will last about 8 weeks with a total of up to 8 visits. 

Project status

We are currently recruiting for both Part B and Part C.

For more information, please contact our team via email participate.maprc@monash.edu , or call 03 9076 6564.

 

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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-nitrous@monash.edu or call 03 9076 6591

 

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.


 
The Damian Project - The Use of Bazadoxifene as a Potential Treatment for Men with Schizophrenia
Thanks to the generous support of the Mohr family, and in honour of the memory of Damian Mohr, MAPrc is privileged to be able to conduct this exiciting new trial to explore the use of Bazadoxifene, a Selective Estrogen Receptor Modulator (SERM), as a potential treatment for men with Schizophrenia.  FOR MORE DETAILS CLICK HERE
 

 
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 us on 9076 6564 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: