Relapse Prevention in Individuals with Depression
This study is exploring whether a weekly injection of an investigational medicine, taken with regular antidepressant medication, can help delay the return of major depressive disorder (MDD) symptoms. It is for adults aged 18 to 75 who are currently in remission or near remission but still experience some ongoing symptoms.
Study overview
This study is exploring whether a weekly injection of an investigational medicine, taken with regular antidepressant medication, can help delay the return of major depressive disorder (MDD) symptoms. It is for adults aged 18 to 75 who are currently in remission or near remission but still experience some ongoing symptoms.
Major depressive disorder (MDD) is a common mental health condition that can return even after successful treatment, affecting daily functioning and overall well-being.
This study is evaluating the safety and effectiveness of an investigational once-weekly injectable treatment for adults with MDD who are in remission or near remission but still have some remaining symptoms. The investigational medicine is being studied to see if it can help delay relapse, support ongoing recovery, and improve long-term outcomes when given alongside regular antidepressant medication.
Am I eligible?
You may be eligible if:
- You are aged 18–75 years old
- You have experienced recurrent depression and are currently in remission or near remission with some ongoing symptoms
- Have been on a stable antidepressant medication for at least 4 weeks
- Able to attend regular clinic visits and receive weekly injections
- You have not received cancer treatment in the last 2 years
- You are using contraception (if applicable)
- Willing to attend the clinic every 4 weeks until the end of study
What taking part involves
If eligible, participants will be on the study for several months. The study includes screening, baseline, treatment, and follow-up phases. Screening and baseline visits each last about 3-4 hours. Treatment visits occur every 4 weeks and last about 2-3 hours, with follow-up visits lasting 2-3 hours. Between some visits, there will be short phone calls of about 15 minutes.
During the treatment period, participants will be randomly assigned to receive either the investigational medicine or placebo, given once weekly by injection in the abdomen, thigh, or upper arm. Some visits will require fasting for at least 8 hours, with water permitted.
Participants will complete health assessments including blood tests (up to 10 in total), ECGs, and mental health questionnaires. They will also be asked to keep a diary throughout the study. This is a double-blind study, meaning neither participants nor the study team will know whether the investigational medicine or placebo is being given.
All visits take place in a supportive environment, and up to $190 reimbursement per visit for time and travel will be provided.
- 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.