An Open-Label, Phase 2a Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
Overview
- Phase
- Phase 2
- Intervention
- BPL-003
- Conditions
- Treatment Resistant Depression
- Sponsor
- Beckley Psytech Limited
- Enrollment
- 52
- Locations
- 3
- Primary Endpoint
- 1. To assess the safety and tolerability of single or multiple intranasal doses of BPL-003 in patients with treatment resistant depression
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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, sertraline or fluoxetine).
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.
Investigators
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 in the past 5 years prior to screening, at least one of which is during the current episode.
- •Montgomery-Asberg Depression Rating Scale score ≥24 at Screening.
- •Clinical Global Impression - Severity ≥4 at Screening.
- •Willing and able to discontinue current pharmacological anti-depressant therapy.
- •On current stable dose of pharmacological antidepressant therapy limited to one of 4 SSRIs (arm B), i.e. either citalopram, escitalopram, sertraline or fluoxetine.
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 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.
- •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.
Arms & Interventions
Arm A
Intervention: BPL-003
Arm B
Intervention: BPL-003
Outcomes
Primary Outcomes
1. To assess the safety and tolerability of single or multiple intranasal doses 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 (Part 1 Arm B only) * Percentage of patients with suicidal ideation or behaviour