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

Phase 2

Recruiting

• Conditions: Treatment Resistant Depression
• Interventions: Drug: BPL-003

• Registration Number: NCT05660642
• Lead Sponsor: Beckley Psytech Limited

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.

Study Timeline

• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Study Start: 2023-02-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Diagnosed with Major Depressive Disorder.
2. 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.
3. Montgomery-Asberg Depression Rating Scale score ≥24 at Screening.
4. Clinical Global Impression - Severity ≥4 at Screening.
5. Willing and able to discontinue current pharmacological anti-depressant therapy.
6. 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

1. Current or history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
2. Current personality disorders.
3. First-degree family history of schizophrenia, bipolar disorder, delusional disorder, personality disorders or schizoaffective disorder.
4. Current alcohol or substance use disorder (other than caffeine or nicotine).
5. 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.
6. 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.
7. Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.
8. Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
9. Seizure disorder or history of seizures (including febrile seizures).
10. Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline.
11. 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.
12. Currently receiving lithium, antipsychotics, serotonergic drugs (excluding the permitted SSRIs for arm B), psychostimulants, or any other prohibited medication.
13. Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception.
14. Male patients who are sexually active and not willing to using adequate forms of contraception.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm B	BPL-003	-
Arm A	BPL-003	-

Primary Outcome Measures

Name	Time	Method
1. To assess the safety and tolerability of single or multiple intranasal doses of BPL-003 in patients with treatment resistant depression	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

Trial Locations

Locations (3)

MAC Clinical Research; 🇬🇧 Liverpool, United Kingdom

Hammersmith Medicines Research; 🇬🇧 London, United Kingdom

King's College London, Clinical Trials Facility; 🇬🇧 London, United Kingdom