BPL-003 Efficacy and Safety in Treatment Resistant Depression

• ClinicalTrials.gov Identifier: NCT05870540
• Recruitment Status: Recruiting
• First Posted: May 23, 2023
• Last Update Posted: May 16, 2024
• Sponsor: Beckley Psytech Limited
• Information provided by (Responsible Party): Beckley Psytech Limited

Tracking Information

• First Submitted Date: May 12, 2023
• First Posted Date: May 23, 2023
• Last Update Posted Date: May 16, 2024
• Actual Study Start Date: September 14, 2023
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 12, 2023)

Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 4 weeks ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 19, 2023)

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

Original Secondary Outcome Measures (submitted: May 12, 2023)

• Change from baseline in MADRS [ Time Frame: 1 week ]
  High compared to low dose of BPL-003
• Change from baseline in MADRS [ Time Frame: 4 weeks and 1 week ]
  Medium compared to low dose of BPL-003
• Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse events [ Time Frame: 8 weeks ]
• Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory tests [ Time Frame: 8 weeks ]
• Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurements [ Time Frame: 8 weeks ]
• Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters compared [ Time Frame: 8 weeks ]
• Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior [ Time Frame: 8 weeks ]
• Plasma levels of 5-MeO-DMT and its metabolites [ Time Frame: 1 day ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: BPL-003 Efficacy and Safety in Treatment Resistant Depression
• Official Title: A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003 in Patients With Treatment Resistant Depression
• 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).

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Quadruple masking: participant, Investigator, therapist, outcomes assessor and Sponsor

Primary Purpose: Treatment

• Condition: Treatment Resistant Depression

Intervention

Drug: BPL-003

A single dose administered intranasally

Study Arms

• Experimental: Low dose
  Active placebo comparator
  Intervention: Drug: BPL-003
• Experimental: Medium dose
  Intervention: Drug: BPL-003
• Experimental: High dose
  Intervention: Drug: BPL-003

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 12, 2023): 225
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Beckley Psytech Ltd; +44 (0)1865 987633; Medinfo@beckleypsytech.com

• Listed Location Countries: Australia, Germany, Poland, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT05870540
• Other Study ID Numbers: BPL-003-201
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Due to the GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion

• Current Responsible Party: Beckley Psytech Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Beckley Psytech Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: VP & Head of Clinical Development; Beckley Psytech Ltd

• PRS Account: Beckley Psytech Limited
• Verification Date: May 2024