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

Research Center: Peninsula Therapeutic and Research Group
Location: 137 Frankston Flinders Road, Frankston VIC, Australia
Lead Doctor: Dr. Jennifer Grunfeld
HREC Committee: This study has been reviewed and approved by the Human Research Ethics Committee of Sydney Local Health District

Background

 

About 350 million people are dealing with major depressive disorder (MDD) worldwide. MDD can cause barriers to living life to the fullest. Linked to harmful outcomes, it can significantly influence the well-being of a person as well as society. Currently, antidepressants only help about half of those who take this form of medication. Despite the many treatment options available, there is still a need for more effective therapies to produce fast symptom resolution. 

Researchers are exploring a new medication for treatment-resistant depression. The study is investigating the effectiveness of a new oral form of treatment for those who have failed to respond to antidepressant medication.  

Interested participants need to have been diagnosed with major depressive disorder (MDD) and be between 18 and 80 years old. They will need to attend the research site in Frankston for 19 study visits, over approximately 20 weeks. At the end of the study, eligible participants can enter a second study, which allows them to continue the study medication for a further 6 months.

Why Participate? 

 

• You may experience an improvement in your depression symptoms. 
• You may be able to receive the study medication and all study-related tests and medical care at no cost.
• You may contribute valuable information that might help others struggling with depression in the future. 
• You may get study-related care from a mental health specialist. 
• You will be reimbursed for any reasonable study-related travel expenses incurred. 
• You will be helping advance mental health research.
• You may be eligible to stay on the study medication for an additional 6 months (as part of a separate study).

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?

 

• Adults aged 18 to 80 years old who are medically diagnosed with major depressive disorder (MDD)
• Participants need to be experiencing a current episode of depression
• Participants need to have tried at least 2 antidepressants for at least 6 weeks during your current episode of depression (you do not need to be currently taking an antidepressant to participate in this study)
• Your depression symptoms have not improved significantly while taking antidepressants
• Participants need to be able to comply with the following study requirements for over approximately 20 weeks:
  • Attend 19 study visits at the research site’s clinic in Frankston (week one of the study involves daily visits to the clinic for five days)

Please note:

 

Due to the current situation with COVID-19 pandemic, 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 sanitisers 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, must immediately self-isolate and will not return to duties until cleared from COVID-19.
• 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 reasonable travel expenses will be reimbursed.
• The research site/institution is taking all precautionary measures to ensure the safety of the study participants.