BPL-003 Efficacy and Safety in Treatment Resistant Depression

PHASE2RECRUITING

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).

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • At least moderate major depressive disorder.
  • 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.
  • Hamilton Depression Rating Scale score ≥19 at Screening and Baseline.
  • CGI-S ≥4 at Screening and Baseline.
  • If currently taking antidepressant medications, willing and able to discontinue current antidepressants.
  • Exclusion criteria

  • Current or past 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, 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.
  • History or current uncontrolled hypertension.
  • Seizure disorder or any seizure in the 2 years prior to Screening.
  • Has clinically significant results on ECG during the Screening.
  • 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.
  • Female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study.
  • Male participants who are sexually active and not willing to use adequate forms of contraception during the study.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-09-14

    Primary completion: 2024-10-01

    Study completion finish: 2024-12-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT05870540

    Intervention or treatment

    DRUG: BPL-003

    Conditions

    • Treatment Resistant Depression

    Find a site

    Closest Location:

    Royal Prince Alfred Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal Prince Alfred Hospital

      Sydney, New South Wales, Australia

    • Dept. of Psychiatry and School Psychological Sciences, Monash University

      Clayton, Victoria, Australia

    • NeuroCentrix Research

      Melbourne, Not Specified, Australia

    • Royal Melbourne Hospital, University of Melbourne

      Parkville, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Low dose
    • Active placebo comparator
    DRUG: BPL-003
    • A single dose administered intranasally
    EXPERIMENTAL: Medium dose
    • Not Specified
    DRUG: BPL-003
    • A single dose administered intranasally
    EXPERIMENTAL: High dose
    • Not Specified
    DRUG: BPL-003
    • A single dose administered intranasally

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)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 0-6.4 weeks

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)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 0-6.1 week
    Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)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 0-6.4 weeks and 1 week
    Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse eventsNot Specified8 weeks
    Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory testsNot Specified8 weeks
    Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurementsNot Specified8 weeks
    Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters comparedNot Specified8 weeks
    Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behaviorNot Specified8 weeks
    Plasma levels of 5-MeO-DMT and its metabolitesNot Specified1 day

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    References

    Clinical Trials Gov: BPL-003 Efficacy and Safety in Treatment Resistant Depression

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