RecruitingPHASE2INTERVENTIONAL

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

This research is investigating a new treatment called BPL-003. It's a special nasal spray designed for individuals whose depression hasn't improved with standard antidepressants, a condition known as treatment-resistant depression. The study aims to understand if BPL-003 is safe to use and how the body reacts to it. Researchers will also look at how effective it is when given alongside talking therapies. Participants will receive either one or two doses of BPL-003, either on its own or in combination with certain commonly prescribed antidepressants like citalopram, escitalopram, sertraline, or fluoxetine. The study will involve regular check-ups over several weeks to see how people respond and if there are any side effects. This is a Phase 2 study, which means it builds on earlier research to gather more information on safety and how well the treatment works.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Beckley Psytech Limited

Enrolment target

Start

10 Feb 2023

Estimated completion

01 Nov 2026

Treatment Resistant Depression

What is this study about?

This study is exploring a new treatment called BPL-003, which is given as a nasal spray, for people who have depression that hasn't gotten better with other medications. This type of depression is sometimes called 'treatment-resistant depression'. The main goals of this research are to see if BPL-003 is safe for people to use, how well they can tolerate it (meaning if it causes side effects or discomfort), and how it works in the body.

Researchers will be looking at BPL-003 in two ways. Some participants might receive BPL-003 on its own, while others might take it alongside their usual antidepressant medication, specifically citalopram, escitalopram, sertraline, or fluoxetine. Everyone taking part in the study will also receive talking therapy, which is a key part of the support offered. This combination approach helps researchers understand the full potential of BPL-003.

This is a Phase 2 study, which means it's an important step in developing new medicines. It's designed to gather more information about how effective the treatment is and to continue checking its safety in a larger group of people than in earlier studies. The aim is to find better ways to help people living with depression that has been difficult to treat.

Key takeaways

Exploring a new nasal spray (BPL-003) for difficult-to-treat depression.
Combines BPL-003 with psychological support.
Will assess safety and how well it's tolerated.
May involve stopping or continuing certain existing antidepressants.
Study duration is between 10 to 12 weeks.
Participants will receive either one or two doses.

Who may be eligible?

This study is looking for adults aged 18 to 75 who have been diagnosed with depression that hasn't responded to previous treatments. Specifically, this means your depression hasn't improved after trying at least two different antidepressant medications in the last five years, with at least one of those being during your current episode of depression.

You might be suitable if you have moderate to severe depression, as measured by standard assessments your doctor would use. If you're currently taking one of four specific SSRI antidepressants (citalopram, escitalopram, sertraline, or fluoxetine) and are willing to stop it, or continue it as part of the study, you could be eligible.

However, some people won't be able to join. This includes if you have a history of serious mental health conditions like schizophrenia or bipolar disorder, or if these conditions run in your immediate family. It also excludes those with current alcohol or drug problems (other than caffeine or nicotine), or if you've recently had suicidal thoughts or attempts. People with certain physical health problems, like uncontrolled diabetes, thyroid issues, kidney problems, or a history of seizures, also wouldn't be able to take part. Finally, if you've already tried treatments like ketamine, esketamine, ECT (electroconvulsive therapy), or certain brain stimulation therapies and they didn't work for you, you won't be able to join this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Has your depression not improved after trying at least two different antidepressants?
Do you not have a history of conditions like schizophrenia or bipolar disorder?
Are you willing to potentially adjust your current antidepressant medication if needed?
Do you not have severe uncontrolled health conditions or a history of seizures?
Have you not had suicidal thoughts or attempts in the last year?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of up to 64 people trying this new treatment. The study is split into two parts. In the first part, up to 32 people will receive a single dose of the BPL-003 nasal spray. In the second part, up to 32 different people will receive two doses of the nasal spray. The doses will be given on different days.

Before, during, and after you receive the BPL-003 nasal spray, you'll also get psychological support, which is like talking therapy. You'll have regular check-ups with the study team. For those receiving a single dose, these follow-up appointments will continue for about 12 weeks. For those receiving two doses, the follow-up period will be approximately 10 weeks. These visits will involve assessments to check your health, how you're feeling, and discuss any side effects. The total duration of your involvement will therefore be up to 12 weeks, depending on which part of the study you are in.

Potential risks and benefits

Participating in this study might mean you get access to a new treatment for depression that isn't widely available yet, which could potentially improve your symptoms. You'll also receive structured psychological support throughout the study. However, like all medicines, BPL-003 may have side effects, and some are unknown at this stage. You might experience discomfort from the nasal spray, or it may not improve your depression. You can also withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

MAC Clinical Research
Verified postcode
Liverpool, United Kingdom· Recruiting
Hammersmith Medicines Research
Verified postcode
London, United Kingdom· Recruiting
King's College London, Clinical Trials Facility
Verified postcode
London, United Kingdom· Completed

Common questions

What is BPL-003?

BPL-003 is a new medication being tested as a nasal spray for people with depression that hasn't responded to other treatments.

What kind of depression is this study for?

This study is for adults with 'treatment-resistant depression', meaning their depression hasn't gotten better with at least two different antidepressant medications.

Will I still take my regular antidepressants?

You might take BPL-003 on its own, or with specific antidepressants (citalopram, escitalopram, sertraline, or fluoxetine). You will need to discuss this with the study team.

What is 'psychological support'?

Psychological support means you'll receive talking therapy or counselling as part of the study, alongside the medication.

How long will I be involved in the study?

Your involvement in the study will last between 10 and 12 weeks, depending on whether you receive one or two doses of BPL-003.

How to find out more

Kevin Craig, M.D.

clinicaltrials@ataibeckley.com 332-282-0507 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.