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

NCT05660642 | Recruiting Phase 2

• 1 other identifier: BPL-003-204
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of one and two doses of intranasal 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).

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• 1. To assess the safety and tolerability of single or multiple intranasal doses 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 or cardiac telemetry abnormalities (Part 1 Arm B only) * Percentage of patients with suicidal ideation or behaviour

  Baseline to 12 weeks post dose

Other Outcomes (4)

• Change from Baseline in MADRS

  Day 2 to 12 weeks post dose

• Percentage of responders

  Day 2 to 12 weeks post dose

• Percentage of patients in remission

  Day 2 to 12 weeks post dose

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: BPL-003

Arm B

EXPERIMENTAL

Drug: BPL-003

Interventions

BPL-003 DRUG

Experimental BPL-003 arms: will investigate one of two doses of BPL-003 (Part 1) and two doses of BPL-003 (Part 2)

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 behaviour within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
• Suicide attempt and/or self-injurious behaviour 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 (excluding the permitted SSRIs for arm B), 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.

Sponsors & Collaborators

• Beckley Psytech Limited: lead

Study Sites (3)

MAC Clinical Research

Liverpool, L34 1BH, United Kingdom

RECRUITING

Hammersmith Medicines Research

London, United Kingdom

RECRUITING

King's College London, Clinical Trials Facility

London, United Kingdom

COMPLETED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• VP and Head of Clinical Development, PhD

  Beckley Psytech Ltd

  STUDY DIRECTOR

Central Study Contacts

Beckley Psytech Ltd

CONTACT

+44 (0)1865 987633; Medinfo@beckleypsytech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: February 10, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)