Almost 1 in 3 people diagnosed with depression – or Major Depressive Disorder (MDD) – do not notice an improvement in their symptoms after trying at least two of the antidepressant drugs available today. This is known as Treatment-Resistant Depression (TRD).
The Elumina study is researching a study drug for people with TRD to learn if it may improve their symptoms of depression.
Modern research has shown that psychedelic drugs may treat mental health conditions, such as depression.
The investigational drug will cause temporary psychedelic effects and may offer a short-term treatment plan for TRD as it is thought to improve depression symptoms.
While there is no guarantee that participants will benefit from receiving the investigational drug, participants’ mental and physical health will be closely monitored while they are in the Elumina study.
Anticipated enrolment close date: June 2026
Who can take part
The Elumina study is enrolling adults aged 18 to 65 who:
- Are diagnosed with MDD and are currently experiencing a depressive episode
- Have tried 2-5 different antidepressant drugs for their current depressive episode
- Do not have a diagnosis of PTSD, OCD, or a psychotic disorder such as schizophrenia
Note that other eligibility requirements apply
What's involved
Pariticipants will need to attend approximately 15 visits, either at the clinic or by phone call, during this study:
- Screening: 2 visits to check that this study is right for you
- Treatment: 3 visits where you will receive the study treatment
- Follow-up: 10 visits where the study team will monitor your health and wellbeing
Study Treatment
Participants will receive a total of 3 doses of study treatment – investigational drug or placebo – during the Elumina study. They will be randomly assigned to receive either:
- 2 doses of placebo + 1 dose of investigational drug
OR
- 3 doses of investigational drug
Both the investigational drug and placebo are given as a thin piece of ‘dissolving film’ placed in the mouth. A placebo looks like the investigational drug but does not contain any active ingredient. Placebos are important for confirming that any effects are due to the investigational drug.
Neither the participant nor study team will know if the participant is receiving the placebo or the investigational drug, known as blinding. This prevents bias in the results of the study.
Participants will receive psychological support sessions throughout their participation in the Elumina study.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.