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BPL-003 Efficacy and Safety in Treatment Resistant Depression
This is a Phase 2 study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).
Study details:
Approximately 225 eligible participants will be receive a single dose of either low, medium, or high doses BPL-003, given intranasally, with 8 weeks of follow-up assessments. Psychological support will be given before, during and after dosing.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-09-14
Primary completion: 2024-10-01
Study completion finish: 2024-12-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05870540
Intervention or treatment
DRUG: BPL-003
Conditions
- • Treatment Resistant Depression
Find a site
Closest Location:
Royal Prince Alfred Hospital
Research sites nearby
Select from list below to view details:
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Dept. of Psychiatry and School Psychological Sciences, Monash University
Clayton, Victoria, Australia
NeuroCentrix Research
Melbourne, Not Specified, Australia
Royal Melbourne Hospital, University of Melbourne
Parkville, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Low dose
| DRUG: BPL-003
|
EXPERIMENTAL: Medium dose
| DRUG: BPL-003
|
EXPERIMENTAL: High dose
| DRUG: BPL-003
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) | High compared to low dose of BPL-003. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0-6. | 4 weeks |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) | High compared to low dose of BPL-003. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0-6. | 1 week |
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) | Medium compared to low dose of BPL-003. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0-6. | 4 weeks and 1 week |
Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse events | Not Specified | 8 weeks |
Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory tests | Not Specified | 8 weeks |
Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurements | Not Specified | 8 weeks |
Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters compared | Not Specified | 8 weeks |
Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior | Not Specified | 8 weeks |
Plasma levels of 5-MeO-DMT and its metabolites | Not Specified | 1 day |
Frequently Asked Questions
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