Clinical Trials Q&A

Firstly, what is a clinical trial? And can you explain the key goals of HER Centre Australia's clinical trials in the field of women's mental health?

A clinical trial is a study that compares responses to different interventions in real settings, to test the effectiveness of medicines or other health measures. Clinical trials are voluntary and are governed by strict rules and ethics. At HER Centre Australia we pride ourselves on conducting gold standard clinical trials in a supportive setting that promotes understanding and treating mental illnesses experienced by women. Our focus is creating interventions and treatments that are tailored to the unique aspects of mental illness through a woman's lifespan.

What factors influence participant selection for your clinical trials? Is a mental health condition a prerequisite for participation?

Participation in our trials involves a thorough history and medical screen process. This ensures the safety of our participants during trial participation. Each trial differs in terms of the study criteria based on the study protocol. Some studies require participants to have a formal diagnosis provided by a mental health professional while others don’t require this as a key inclusion criteria. The pre-screening phase is the term used to describe activities before obtaining informed consent (i.e., before enrolment) to determine initial eligibility for and interest in a study. During this initial phase our study coordinators will perform pre-screening with potential participants over the telephone, in-person or on-line and may not include any research procedures.

Could you describe the typical process a participant goes through when they join one of our clinical trials?

Prospective participants typically start with a pre-screening phone call, during which our researchers discuss eligibility criteria and walk them through the process. Those who qualify will then attend a screening visit, involving a detailed physical exam and clinical interviews to confirm suitability for the study. If eligible, they proceed to a baseline appointment, where we collect initial data for comparison against end-of-study data. This is also when they begin the trial intervention or treatment. Time commitments vary across studies, but typically involve a mix of in-person and phone visits throughout the trial. At the end, participants have the opportunity to receive study feedback, and in some cases, learn whether they were allocated the active or placebo.

What measures does HER Centre Australia take to ensure the safety and wellbeing of participants during clinical trials? What support and resources are provided to participants throughout the trial?

All clinical trials obtain ethics approval to certify that appropriate methods are in place, ensuring the utmost safety and wellbeing of participants. As per each protocol, participants are monitored throughout the clinical trials for changes in potential adverse and/or beneficial effects. These are reviewed by the medical officer and actioned accordingly with the participant. Prior to the commencement of each study, a thorough physical exam is conducted to ensure each participant is fit to be on the intervention. This includes a full blood examination and ECG trace. The research psychologist also conducts various scales to assess each participants’ past and current mental health history, which aids the management of participants throughout the trial. Our clinical trial team also liaises with the treating team of each individual to provide any feedback concerning the safety and wellbeing of the participant throughout the clinical trial.

In what ways do the insights gained from clinical trials influence the development of new therapies and interventions for mental health conditions?

Our clinical trials contribute significantly to the advancement of mental health therapies and interventions. By investigating existing medications on the market, originally prescribed for different conditions, we explore their potential efficacy in addressing other mental health symptoms. We are currently investigating whether widely used diabetes and blood cholesterol medications can improve depressive symptoms. Additionally, several studies examine the impact of hormone replacement therapy on perimenopausal depression and the use of hormonal medications in brain fog commonly experienced in schizophrenia. This approach allows us to uncover novel applications for medications and develop targeted treatments for mental health conditions

How does the HER Centre Australia team collaborate with other healthcare professionals and participants to tailor treatments based on individual needs and experiences?

Our collaborative approach involves close communication between our medical and study teams, the participant's treating healthcare professionals, and the participants themselves. We actively seek input from the treating team to understand the participant's unique needs and experiences, ensuring a comprehensive view of their health. This collaboration allows us to tailor treatments based on individual circumstances and guarantees participant safety throughout the trial. Importantly, our protocols and procedures are informed by lived/living experience, and we collect post-study feedback to continually enhance our practices. Participants can expect not only to contribute to cutting-edge research but also to receive personalised, safe, and respectful care throughout their involvement in a HER Centre trial.

Can you elaborate on the technologies and innovative methodologies used in our clinical trials, and how they enhance the research process?

At HER Centre Australia, we leverage cutting-edge technologies and methodologies to advance the research process in our clinical trials. Through Monash University and Alfred Health, we have access to state-of-the-art equipment, including Transcranial Magnetic Stimulation (TMS), which enables more precise and impactful research outcomes. We utilise online surveys distributed via email, allowing participants to conveniently engage with the study from the comfort of their homes using mobile or stationary devices. In addition to traditional recruitment methods, we harness social media to promote our studies, reaching a diverse audience. Our online expression of interest form helps determine the most suitable study for each participant based on their unique characteristics. Insights gathered from our clinic and women's mental health experts contribute invaluable perspectives to these studies.

How does HER Centre Australia ensure that its clinical trials are inclusive and culturally sensitive to the diverse backgrounds and experiences of female and gender diverse participants?

We prioritise inclusivity and cultural sensitivity in our clinical trials, recognising that people may experience the same illness differently. We intentionally include participants with a diverse range of lived experiences, encompassing characteristics such as race, ethnicity, age, sex, and sexual orientation. By fostering diversity in our trials, we aim to ensure that scientific advances benefit all communities and contribute to a more comprehensive understanding of mental health conditions.

What misconceptions do you commonly hear about clinical trials? And can you demystify them?

1. “Clinical Trials aren’t safe to participate in”  The studies at HER Centre Australia involve safe and innovative medications (some of which have been approved by the TGA, others have gone through a strict safety testing in earlier phase Clinical Trials). With the constant monitoring and support of our multidisciplinary healthcare team, Clinical Trials are a very safe way to contribute to the development of new treatments and potentially experience an improvement in symptoms.
2. “Once I join, I can’t change my mind” Participants are free to withdraw from the study at any point in time. If you do withdraw, this does not exclude you from other trials and you are always welcome to join a different trial in the future.
3. “Clinical Trials are only the last resort”
   Participating in a clinical trial is a proactive and valuable choice. Through participation, people can gain in-depth insights into their condition without incurring high medical costs.
4. “The time commitment is always unreasonable”  While some appointments can be time consuming, our team works with participants to ensure flexibility - previous arrangements included split appointments and appointments out of hours. We also provide medical certificates for each visit should you need time off work.
5. “If I participate, I am bound to get placebo”  The chance of getting placebo is normally 50/50. While this is a factor to consider when deciding to participate, being part of a clinical study brings many more benefits, such as support and care of our clinical team, familiarizing yourself with your own condition, or contributing to society.

Could you share some success stories or positive outcomes from past clinical trials that have had a lasting impact on participants' lives

“ Everyone I dealt with was professional and explained every step of the process. I enjoyed being part of the study”

“Staff were very considerate and helpful. Explained the information clearly”

“ Loved it ! I wouldn’t mind doing another trial

Lastly, how can people get involved in the current clinical trials we have running?

Our Clinical Trials can be found on the HER Centre website

https://www.monash.edu/medicine/her-centre/health/clinical-trials

If you have any questions or would like more information about our clinical trials, our dedicated Study Coordinators are here to help.

Please reach out via email: hercentreaustralia@monash.edu or phone: +61 3 9076 8156

Participants can complete the online form via the link https://forms.gle/NVDoPfF6TemRPRTAA and we will be in contact within a few business days.

Your involvement in a clinical trial can make a meaningful impact on the future of women's mental health treatment