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An Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT05660642
Recruitment Status : Recruiting
First Posted : December 21, 2022
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
Beckley Psytech Limited

Study Description
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Brief Summary:
An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of a single intranasal dose of BPL-003 combined with psychological support, in patients with treatment resistant depression when administered as monotherapy or as adjunctive therapy with defined SSRIs (citalopram, escitalopram, or sertraline).

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Drug: BPL-003 Phase 2

Detailed Description:
Up to 52 patients, across 2 parallel arms (Arms A and Arms B) will receive one of two single doses of BPL-003, given intranasally, with 12 weeks of follow-up assessments. Psychological support will be given before, during and after dosing.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 2a, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
Actual Study Start Date : February 10, 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A Drug: BPL-003
Experimental BPL-003 arms: will investigate one of two doses of BPL-003
Experimental: Arm B Drug: BPL-003
Experimental BPL-003 arms: will investigate one of two doses of BPL-003


Outcome Measures
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Primary Outcome Measures :
  1. To assess the safety and tolerability of a single intranasal dose of BPL-003 in patients with treatment resistant depression [ Time Frame: Baseline to 12 weeks post dose ]
    • Percentage of patients with treatment emergent adverse events
    • Percentage of patients with clinically significant abnormal laboratory tests
    • Percentage of patients with clinically significant abnormal vital signs
    • Percentage of patients with clinically significant findings in physical examination
    • Percentage of patients with clinically significant ECG parameters or cardiac telemetry abnormalities (Arm B only)
    • Percentage of patients with suicidal ideation or behavior


Other Outcome Measures:
  1. Change from Baseline in MADRS [ Time Frame: Day 2 to 12 weeks post dose ]
  2. Percentage of responders [ Time Frame: Day 2 to 12 weeks post dose ]
    Defined as 50% reduction in MADRS score compared to Baseline

  3. Percentage of patients in remission [ Time Frame: Day 2 to 12 weeks post dose ]
    Defined as MADRS score of <11

  4. Plasma levels of 5-MeO-DMT and its metabolite (bufotenine) [ Time Frame: Day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with Major Depressive Disorder.
  2. Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments.
  3. Montgomery-Asberg Depression Rating Scale score ≥24 at Screening.
  4. Clinical Global Impression - Severity ≥4 at Screening.
  5. Willing and able to discontinue current pharmacological anti-depressant therapy.
  6. On current stable dose of pharmacological antidepressant therapy limited to one of 3 SSRIs (arm B), i.e. either citalopram, escitalopram, or sertraline.

Exclusion Criteria:

  1. Current or 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, personality disorders 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 with the intent to act or suicidal 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. Seizure disorder or history of seizures (including febrile seizures).
  10. Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline.
  11. Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing, that in the Investigator's opinion may interfere with administration of the study drug.
  12. Currently receiving lithium, antipsychotics, serotonergic drugs (excluding the permitted SSRIs for arm B), psychostimulants, or any other prohibited medication.
  13. Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception.
  14. Male patients who are sexually active and not willing to using adequate forms of contraception.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05660642


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

Locations
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United Kingdom
Hammersmith Medicines Research Recruiting
London, United Kingdom
Contact: Study Coordinator    +44 (0)20 8961 4130    REC@hmrlondon.com   
King's College London, Clinical Trials Facility Active, not recruiting
London, United Kingdom
Sponsors and Collaborators
Beckley Psytech Limited
Investigators
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Study Director: VP & Head of Clinical Development, MD, PhD Beckley Psytech Ltd
More Information
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Responsible Party: Beckley Psytech Limited
ClinicalTrials.gov Identifier: NCT05660642    
Other Study ID Numbers: BPL-003-204
First Posted: December 21, 2022    Key Record Dates
Last Update Posted: February 6, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
 Behavioral Symptoms
Mood Disorders
Mental Disorders