New Potential Treatment for Perimenopausal Major Depressive Disorder

Please note: This trial has finished recruiting and is not accepting new participants.

Research Center: Epworth Clinic
Location: 888 Toorak Road, Camberwell, Victoria 3124 Australia
Lead Doctor: Professor Paul Fitzgerald
Ethics Committee: This study has been reviewed and approved by Bellberry Human Research Ethics Committee

Background

Major Depressive Disorder (MDD) is a common psychiatric illness that causes disability and diminishes quality of life, and has been shown to increase the rates of substance abuse and suicide. The prevalence of MDD in Australia is approximately 5%. 

Unfortunately, current treatments available are not always effective in reducing symptoms of depression. To date, treatment options for MDD have limitations such as delayed onset of benefit and high rates of treatment failure. Researchers are currently exploring if a new investigational treatment can better relieve symptoms of MDD. Findings from this study may help others with MDD in the future.

This study seeks women who currently suffer from MDD. Participants will be required to stay at the research centre as an in-patient for 7-consecutive nights during which daily assessments and dosing will occur. After the in-patient stay, there will be 3 follow up visits over the following 3 weeks. Participants will be reimbursed for costs associated with participating in this study (e.g. travel).

Participants will be required to attend approximately 6 outpatient clinic visits over approximately 5 weeks.

Why Participate? 

  • You will be reimbursed actual costs that you incur as a direct result of  participating in this study, such as travel, parking, etc.
  • If you are traveling outside Victoria, you will still be reimbursed actual costs that you incur as a direct result of  participating in this study, such as travel, parking, meals, etc.
  • You will be helping to advance medical research.

Your Rights

  • If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
  • Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.
  • Qualified health professionals will monitor your health as it relates to the study.

Who Can Participate?

  • Women aged 40+ who are currently diagnosed with severe major depressive disorder.
  • With at least one irregular menstrual cycle.
  • Experiencing vasomotor symptoms (such as hot flushes or night sweats).
  • Are not diagnosed with bipolar disorder or schizophrenia. 
  • Able to attend 6 visits at the research centre over a total of approximately 7 weeks.

Please note:

Due to the current situation with COVID-19 outbreaks, the study team would like to point out the following:

  • The research site does not treat COVID-19 patients and/or suspected COVID-19 patients.
  • The research site’s waiting area is spacious enough that participants will not be within close proximity to each other.
  • Hand sanitizers are available at the research site.
  • The research staff adheres to strict hygienic practices as well as other safety measures to prevent the spread of COVID-19. 
  • Any staff suspected to have COVID-19, or has come into contact with someone who has COVID-19, will automatically undergo a voluntary quarantine for 14 days.
  • Interested participants will not be left waiting for a long period of time and will be quickly attended to. 
  • Parking is available at the research site.
  • The study team encourages the use of personal vehicles, taxi or rideshare services rather than public transit. All travel expenses will be reimbursed.
  • The research site/institution is taking all precautionary measures to ensure the safety of the study participants.

What Next?

  1. Click the link below to enter your contact details and answer some eligibility questions.
  2. The research centre will then contact you by phone to discuss the trial and answer your questions.
Click Here to Enter Your Contact Details and Be Contacted by Phone About the Trial

Is This Study Not For You?

Enter your details to be notified via email about new studies in your area