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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05870540




Registration number
NCT05870540
Ethics application status
Date submitted
12/05/2023
Date registered
23/05/2023
Date last updated
30/05/2024

Titles & IDs
Public title
BPL-003 Efficacy and Safety in Treatment Resistant Depression
Scientific title
A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003 in Patients With Treatment Resistant Depression
Secondary ID [1] 0 0
BPL-003-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BPL-003

Experimental: Low dose - Active placebo comparator

Experimental: Medium dose -

Experimental: High dose -


Treatment: Drugs: BPL-003
A single dose administered intranasally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [2] 0 0
4 weeks and 1 week
Secondary outcome [3] 0 0
Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse events
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory tests
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurements
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters compared
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior
Timepoint [7] 0 0
8 weeks
Secondary outcome [8] 0 0
Plasma levels of 5-MeO-DMT and its metabolites
Timepoint [8] 0 0
1 day

Eligibility
Key inclusion criteria
1. At least moderate major depressive disorder.

2. 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.

3. Hamilton Depression Rating Scale score =19 at Screening and Baseline.

4. CGI-S =4 at Screening and Baseline.

5. If currently taking antidepressant medications, willing and able to discontinue
current antidepressants.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current or past history of schizophrenia, psychotic disorder including psychotic
depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any
other severe psychiatric disorder.

2. Current personality disorders.

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

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

5. 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.

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

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

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

9. History or current uncontrolled hypertension.

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

11. Has clinically significant results on ECG during the Screening.

12. 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.

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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Dept. of Psychiatry and School Psychological Sciences, Monash University - Clayton
Recruitment hospital [3] 0 0
NeuroCentrix Research - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital, University of Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Frankfurt am Main
Country [15] 0 0
Germany
State/province [15] 0 0
Mannheim
Country [16] 0 0
Germany
State/province [16] 0 0
Tubingen
Country [17] 0 0
Poland
State/province [17] 0 0
Gdansk
Country [18] 0 0
Poland
State/province [18] 0 0
Tuszyn
Country [19] 0 0
Poland
State/province [19] 0 0
Warsaw
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Oviedo
Country [23] 0 0
Spain
State/province [23] 0 0
Salamanca
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Beckley Psytech Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05870540
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
VP & Head of Clinical Development
Address 0 0
Beckley Psytech Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Beckley Psytech Ltd
Address 0 0
Country 0 0
Phone 0 0
+44 (0)1865 987633
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05870540