This large international trial will examine the efficacy and safety of a new psychedelic-assisted therapy for treatment-resistant depression.
We are inviting adults with treatment-resistant depression to take part in this novel research trial into the efficacy and safety of a new drug, BPL-003, that contains a psychedelic compound called 5-MeO-DMT.
Eligible participants will receive either a high, medium, or very low dose of the study drug, as well as psychotherapy sessions, during the core phase of the study.
Participants may also be eligible to complete an additional open label extension phase if they wish, where they will receive a high dose of the study drug plus additional psychotherapy sessions.
Anticipated enrolment close date: August 2024
Who can take part
This trial might be right for you if you:
- Are aged 18 to 75 years
- Currently have treatment-resistant major depressive disorder
- Are willing and able to discontinue your current antidepressant medications
- Do not have a current or past history of a bipolar or psychotic disorder
- Have not had an alcohol or substance use disorder within the past 12 months
Please note that other eligibility criteria apply.
What's involved
- Core phase: three preparation therapy visits, one treatment visit, and three integration therapy visits, plus follow-up for six weeks after treatment
- Open label extension phase: if eligible, two preparation therapy visits, one treatment visit, and three integration therapy visits, plus follow-up for six weeks after treatment
- Interviews and questionnaires
- Blood and urine tests, including urine drug screens
- Electrocardiogram (ECG)
Study duration
Participation in the core phase of the study will take up to 16 weeks.
Participation in the open label extension phase will take an additional 9 weeks.
The total duration of this trial is approximately 12 months.
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.