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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

Primary Purpose

Treatment Resistant Depression

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
BPL-003
Sponsored by
Beckley Psytech Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with Major Depressive Disorder. Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments. Montgomery-Asberg Depression Rating Scale score ≥24 at Screening. Clinical Global Impression - Severity ≥4 at Screening. Quick Inventory of Depressive Symptomatology - Self Rated - 16 item scale ≥13 at Screening. Willing and able to discontinue current pharmacological anti-depressant therapy. Exclusion Criteria: Current or 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, personality disorders 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. Seizure disorder or history of seizures (including febrile seizures). Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline. 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. Currently receiving lithium, antipsychotics, serotonergic drugs, psychostimulants, or any other prohibited medication. Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception. Male patients who are sexually active and not willing to using adequate forms of contraception.

Sites / Locations

  • Hammersmith Medicines ResearchRecruiting
  • King's College London, Clinical Trials FacilityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BPL-003 arm

Arm Description

Outcomes

Primary Outcome Measures

To assess the safety and tolerability of a single intranasal dose of BPL-003 in patients with treatment resistant depression
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 Percentage of patients with suicidal ideation or behavior

Secondary Outcome Measures

Full Information

First Posted
December 13, 2022
Last Updated
March 29, 2023
Sponsor
Beckley Psytech Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05660642
Brief Title
An Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beckley Psytech Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability and pharmacodynamics after a single intranasal dose of BPL-003 combined with psychological support, in patients with treatment resistant depression not currently taking antidepressants.
Detailed Description
Approximately 12 eligible participants will be receive a single dose of BPL-003, given intranasally, with 12 weeks of follow-up assessments. Psychological support will be given before, during and after dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BPL-003 arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BPL-003
Intervention Description
Single dose administered intranasally
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of a single intranasal dose of BPL-003 in patients with treatment resistant depression
Description
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 Percentage of patients with suicidal ideation or behavior
Time Frame
Baseline to 12 weeks post dose
Other Pre-specified Outcome Measures:
Title
Change from Baseline in MADRS
Time Frame
Day 2 to 12 weeks post dose
Title
Percentage of responders
Description
Defined as 50% reduction in MADRS score compared to Baseline
Time Frame
Day 2 to 12 weeks post dose
Title
Percentage of patients in remission
Description
Defined as MADRS score of <11
Time Frame
Day 2 to 12 weeks post dose
Title
Plasma levels of 5-MeO-DMT and its metabolite (bufotenine)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Major Depressive Disorder. Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments. Montgomery-Asberg Depression Rating Scale score ≥24 at Screening. Clinical Global Impression - Severity ≥4 at Screening. Quick Inventory of Depressive Symptomatology - Self Rated - 16 item scale ≥13 at Screening. Willing and able to discontinue current pharmacological anti-depressant therapy. Exclusion Criteria: Current or 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, personality disorders 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. Seizure disorder or history of seizures (including febrile seizures). Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline. 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. Currently receiving lithium, antipsychotics, serotonergic drugs, psychostimulants, or any other prohibited medication. Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception. Male patients who are sexually active and not willing to using adequate forms of contraception.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beckley Psytech Ltd
Phone
+44 (0)1865 987633
Email
Medinfo@beckleypsytech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer, MD, PhD
Organizational Affiliation
Beckley Psytech Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Hammersmith Medicines Research
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+44 (0)20 8961 4130
Email
REC@hmrlondon.com
Facility Name
King's College London, Clinical Trials Facility
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Facility
Email
5-meo-dmt@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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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