Investigational Implantable Device for Depression in Adults
This study is evaluating an investigational implantable medical device for people living with treatment-resistant depression. The device is surgically implanted beneath the skin and above a specific area of the brain involved in regulating mood. Once implanted, it delivers gentle electrical stimulation to that area. Researchers are studying whether this investigational device can be used safely and whether it may help improve symptoms of depression. The investigational device has not been approved by the Therapeutic Goods Administration (TGA) for routine treatment use in Australia.
Study overview
This study is evaluating an investigational implantable medical device for people living with treatment-resistant depression. The device is surgically implanted beneath the skin and above a specific area of the brain involved in regulating mood. Once implanted, it delivers gentle electrical stimulation to that area. Researchers are studying whether this investigational device can be used safely and whether it may help improve symptoms of depression. The investigational device has not been approved by the Therapeutic Goods Administration (TGA) for routine treatment use in Australia.
The study aims to understand:
• How safe and well-tolerated the investigational device is
• Whether it may help improve symptoms of depression
• How participants respond over time
• How participants’ wellbeing and safety can be monitored throughout the study
Am I eligible?
The study may be suitable for you if:
- You are 22–85 years old
- You have been diagnosed with depression that has not responded to treatment (TRD)
- You are currently experiencing depressive symptoms (MDD)
- You are willing and able to attend scheduled study visits, imaging appointments, surgical appointments, and follow-up assessments
- You are able to commit to the full study duration (approximately 12 months)
What taking part involves
Participation involves a device implantation procedure, scheduled clinic visits, imaging appointments, phone calls, and ongoing follow-up assessments. Main study participation lasts for approximately 12 months after the first study treatment, and the overall study runs for approximately 28 months.
- 1
Enquiry & phone call
We call to explain the study and answer your questions.
- 2
Screening visit
Meet the team and have health checks to confirm eligibility.
- 3
Study visits
Regular visits with expert care and health monitoring.
- 4
Final visit & follow-up
A wrap-up check and a thank-you for helping research.
Still have questions?
Our team is happy to talk it through. Call 1300 742 326.
Frequently asked questions
A clinical trial is a research study involving volunteers that helps researchers evaluate new treatments, medications, medical devices or approaches to healthcare. Clinical trials help determine whether these interventions are safe, effective and appropriate for wider use.
Clinical trials help advance healthcare by showing how treatments work, identifying possible side effects and exploring new ways to prevent, diagnose and manage medical conditions. By taking part, volunteers contribute to knowledge that may benefit people in the future.
Each trial has its own eligibility criteria, which may relate to your age, medical history, health conditions or current medications. Some studies are for people with a specific condition, while others involve healthy volunteers. Our research team can help you understand whether a study may be suitable.
Participant safety and wellbeing are central to clinical research. In Australia, trials must meet strict ethical and regulatory requirements and are reviewed by a Human Research Ethics Committee (HREC). Participants are monitored throughout the study.
All clinical trials involve some uncertainty and level of risk. Before you decide, the research team will explain the known and potential risks, possible benefits and available alternatives.