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

Research Centre: Ramsay Clinic Albert Road
Location: Ramsay Clinic Albert Road, 31 Albert Road Melbourne, 3004
Lead Researcher: Prof Malcolm Hopwood
HREC: This study has been reviewed and approved by the Bellberry Limited Human Research Ethics Committee

Are you currently on an SSRI or SNRI antidepressant medication but not seeing any improvement in your depressive symptoms? Researchers invite you to join this clinical study exploring Aticaprant 10mg as an adjunctive therapy. This research aims to determine the safety and effectiveness of Aticaprant when added to existing treatment plans for depression.

In this study, participants will receive Aticaprant 10mg alongside their current antidepressant regime under professional supervision. Your participation could play a crucial role in advancing our understanding of depression treatment and potentially benefitting countless individuals struggling with this condition. Join this study to help researchers uncover more effective depression therapies.

• Participants will receive a new potential add-on treatment for depression at no cost.
• Participants will be contributing valuable information that may benefit those with major depressive disorder in the future.
• Participants will be helping to advance medical research.

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

• Individuals aged 18 – 74 years who are diagnosed with major depressive disorder
• Must have a BMI of 18 – 40 kg/m²
• Must have been experiencing a recurrent or single episode of depression
• Must be on a stable dose of an SSRI or SNRI antidepressant for at least 6 weeks
• Must be willing to refrain from donating eggs (if female) or sperm (if male) during the duration of the study and for a minimum of 1 month after the last dose of the study intervention
• Must have been compliant with current antidepressant therapy
• Must not have been diagnosed with a substance use disorder within the past 6 months
• Must not have started any psychological treatments within the past 6 weeks
• Must not have participated in another clinical trial within the past year or received an investigational intervention for depression within the past 60 days
• Must be able to attend 6 study visits and 4 telephonic visits over approximately 12 weeks

The study team will explain the research in its entirety but some details are:

• Participants will have their medical and psychiatric history reviewed by study staff. This will involve asking questions about their family history of depression, current employment status and any plans for surgery or procedures
• Participants will have a physical exam done, where things such as height, weight, and vital signs will be taken and measured
• Participants will be required to undergo testing, including but not limited to:
  • Alcohol breath test
  • Menstrual cycle tracking
  • Blood tests
  • Electrocardiogram (ECG)
  • Pharmacokinetic testing
  • Biomarker analysis
  • Genetic testing

Ramsay Clinic Albert Road
Ramsay Clinic Albert Road is a dedicated mental health care facility in the heart of Melbourne. We offer acute inpatient services, neurostimulation services and a wide range of day and community programs for people requiring treatment for mood and anxiety disorders, psychosis, addictions, trauma, and post-traumatic stress disorder. We take a holistic approach to care, providing individualised support that is delivered by a multidisciplinary team of healthcare professionals. The Ramsay Clinic Albert Road is part of the Ramsay Health Care Network. Our vision is to be a leading healthcare provider of the future. We are proudly driven by our long-standing purpose of ‘people caring for people’. We are guided by our values, which we call The Ramsay Way.

Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.