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BPL-003 Efficacy and Safety in Treatment Resistant Depression

PHASE2RECRUITING

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).

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

At least moderate major depressive disorder.

Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments based on the MGH ATRQ assessment.

Hamilton Depression Rating Scale score ≥19 at Screening and Baseline.

CGI-S ≥4 at Screening and Baseline.

If currently taking antidepressant medications, willing and able to discontinue current antidepressants.

Exclusion criteria

Current or past history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.

Current personality disorders.

First-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder.

Current alcohol or substance use disorder (other than caffeine or nicotine).

A participant who at any time has been unresponsive to ketamine, esketamine, an adequate course of treatment with electroconvulsive therapy, or has received vagal nerve stimulation or deep brain stimulation.

Suicidal ideation or behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.

Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.

Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.

History or current uncontrolled hypertension.

Seizure disorder or any seizure in the 2 years prior to Screening.

Has clinically significant results on ECG during the Screening.

Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing that in the investigator's opinion may interfere with the administration of the study medication.

Female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study.

Male participants who are sexually active and not willing to use adequate forms of contraception during the study.

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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

Image related to Treatment Resistant Depression

Condition: Treatment Resistant Depression
DRUG: BPL-003
Sydney, New South Wales, Australia and more
Sponsor: Beckley Psytech Limited

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 Active placebo comparator	DRUG: BPL-003 A single dose administered intranasally
EXPERIMENTAL: Medium dose Not Specified	DRUG: BPL-003 A single dose administered intranasally
EXPERIMENTAL: High dose Not Specified	DRUG: BPL-003 A single dose administered intranasally

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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References

Clinical Trials Gov: BPL-003 Efficacy and Safety in Treatment Resistant Depression