Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003, with Open Label Extension, in Patients with Treatment Resistant Depression

This research study is about a new nasal spray medicine called BPL-003. It's for adults who have severe depression that hasn't improved with other common treatments. This is called Treatment-Resistant Depression. The study aims to find the best dose of BPL-003 by testing different amounts. Researchers will carefully check how much the participants' depression symptoms improve and closely monitor for any side effects. They will also look at heart health, blood tests, and mood changes, including thoughts about self-harm. The study is divided into two parts: a core part to test doses, and an extension part for long-term monitoring.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Beckley Psytech Limited

Enrolment target

Start

24 Sep 2024

Treatment-Resistant Depression (TRD)

What is this study about?

This study is looking into a new treatment for a type of depression called Treatment-Resistant Depression (TRD). This means that people with TRD have tried various other treatments for their depression, but these haven't helped enough. The new treatment being tested is a nasal spray called BPL-003.

The main goal of the study is to figure out the right dose of BPL-003. The researchers will give different doses to participants to see which one works best to improve depression symptoms while also being safe. They will use a special rating scale to measure changes in depression. They will also carefully check for any side effects, changes in vital signs like heart rate and blood pressure, and results from blood tests.

Understanding how well this new nasal spray works and whether it's safe is very important. This study could help people who have struggled to find effective treatment for their depression. It's an early-stage study, meaning we're learning fundamental things about this new medicine.

Key takeaways

This study is for adults with depression that hasn’t improved with other treatments.
It’s testing a new nasal spray called BPL-003 to find the best dose.
Researchers will closely monitor how well it works and look for any side effects.
Participation involves regular clinic visits, tests, and being monitored.
It's an early-stage study, so understanding its effects is still developing.

Who may be eligible?

To be part of this study, you must be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you would need to have been diagnosed with what doctors call 'Treatment-Resistant Depression.' This means your depression hasn't gotten better even after trying other commonly used treatments.

There might be other health conditions or medications that would prevent you from joining, but these details are not fully provided here. A doctor involved in the study would need to check your full medical history.

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 18 years old or older?
Have you been diagnosed with depression?
Has your depression not improved much after trying other treatments?
Are you able to attend regular clinic visits for assessments?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the study clinic. You would receive the BPL-003 nasal spray at specific doses. Researchers would closely monitor your depression symptoms using questionnaires and rating scales. You would also have physical examinations, blood tests, and checks of your heart activity (ECG) and vital signs like heart rate and blood pressure.

Some parts of the study will involve checking for changes in your thinking abilities. There will also be regular checks for any thoughts of self-harm. The study is divided into a main dose-finding part and an 'open label extension' part, which is for longer-term monitoring of the treatment's effects and safety. The total duration of your participation would be explained by the study team.

Potential risks and benefits

Potential benefits of joining this study include getting access to a new treatment (BPL-003) that might help your depression if other treatments haven't worked. You would also receive close medical attention and monitoring. However, there are potential risks, as with any new medication. These might include side effects from the nasal spray, which could affect your heart, blood, or mental state. There's also a risk that the treatment may not work for you. You have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (3)

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

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Unverified
Poland
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Unverified
Spain
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Unverified
Germany

Common questions

What is Treatment-Resistant Depression?

This is when someone's depression hasn't significantly improved after trying usual treatments like antidepressants.

What is BPL-003?

BPL-003 is the name of the new nasal spray medicine being tested in this study for depression.

Why is this study being done?

The study aims to find the right dose of BPL-003 that is both effective and safe for people with Treatment-Resistant Depression.

Will I know if I'm getting the actual medicine?

In the main part of the study, neither you nor the doctors will know who is getting which dose. This is called 'quadruple masked' to ensure fair testing. There's also an 'open label extension' where everyone knows they are getting the medicine.

What kind of tests will I have?

You'll have tests for your depression symptoms, physical exams, blood tests, heart checks (ECG), and measurements of your concentration and memory.