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

  • STATUS
    Recruiting
  • days left to enroll
    7
  • participants needed
    12
  • sponsor
    Beckley Psytech Limited
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Updated on 9 April 2023
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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.

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.

Details
Condition Treatment Resistant Depression
Treatment BPL-003
Clinical Study IdentifierNCT05660642
SponsorBeckley Psytech Limited
Last Modified on9 April 2023

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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