RecruitingPhase 2NCT05660642

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

An Open-Label, Phase 2a Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression


Sponsor

Beckley Psytech Limited

Enrollment

64 participants

Start Date

Feb 10, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new experimental therapy called BPL-003 for people with treatment-resistant depression (TRD) — meaning their depression has not improved after trying at least two antidepressant medications. Researchers want to understand how safe and effective this new treatment is. **You may be eligible if...** - You have been diagnosed with Major Depressive Disorder (MDD) - Your depression has not responded to at least 2 antidepressant medications in the past 5 years - Your depression symptoms are currently severe (based on a standard rating scale) - You are currently taking one of these antidepressants: citalopram, escitalopram, sertraline, or fluoxetine - You are willing to stop your current antidepressant as part of the study **You may NOT be eligible if...** - You have schizophrenia, bipolar disorder, psychosis, or a personality disorder - You have a family history of certain psychiatric conditions (schizophrenia, bipolar disorder) - You have a current alcohol or drug use disorder - You have previously not responded to ketamine, electroconvulsive therapy (ECT), vagal nerve stimulation, or deep brain stimulation - You have had suicidal thoughts with intent to act within the past 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBPL-003

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


Locations(3)

MAC Clinical Research

Liverpool, United Kingdom

Hammersmith Medicines Research

London, United Kingdom

King's College London, Clinical Trials Facility

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05660642


Related Trials