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

Study Overview
=================
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.

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

Conditions
-----------------
Treatment Resistant Depression

Intervention / Treatment
-----------------
* Drug: BPL-003


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPL-003 arm<br> | Drug: BPL-003<br>* Single dose administered intranasally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to 12 weeks post dose |