Not recruiting

Study on the Effectiveness and Safety of Intranasal BPL-003 for Patients with Treatment-Resistant Depression

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Treatment-Resistant Depression (TRD). TRD is a type of depression that does not improve after trying at least two different treatments. The study is testing a new treatment called BPL-003, which is a nasal powder containing the active substance mebufotenin benzoate. This treatment is being developed by Beckley Psytech Ltd and is administered through the nose.

The purpose of the study is to evaluate how effective and safe BPL-003 is for people with TRD. Participants will receive the treatment along with psychological support. The study will have two parts: an initial phase to determine how well the treatment works and a follow-up phase to assess its safety. During the study, participants will be monitored for any changes in their depression symptoms and any side effects they might experience.

Participants will be asked to attend several study visits where they will receive the treatment and undergo assessments. These assessments will help researchers understand how the treatment affects depression symptoms and overall health. The study aims to provide valuable information on whether BPL-003 can be a helpful option for people with TRD who have not found relief with other treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants are required to provide informed consent. This involves understanding the study's purpose and agreeing to participate.
Participants must be between 18 and 75 years old and have a diagnosis of treatment-resistant depression, which means they have not responded to at least two different treatments for depression.
Step 2
Initial assessment
Participants undergo an initial assessment to confirm eligibility. This includes a review of medical history and current medications.
Participants must stop taking any current antidepressant medications, following a gradual reduction plan to avoid withdrawal symptoms.
Step 3
Core study phase
During the core study phase, participants receive the study medication, BPL-003, administered as a nasal powder.
The dosage and frequency of administration are determined by the study protocol, and participants receive psychological support throughout this phase.
Step 4
Monitoring and assessments
Participants are regularly monitored for changes in their depression symptoms using various scales, such as the Montgomery-Asberg Depression Rating Scale (MADRS).
Regular health checks are conducted to monitor vital signs, laboratory tests, and any potential side effects.
Step 5
Open label extension (OLE)
Participants who complete the core study may enter the open label extension phase, where they continue to receive BPL-003 and psychological support.
The focus of this phase is to assess the long-term safety of the medication.
Step 6
Final assessments and study completion
At the end of the study, participants undergo final assessments to evaluate the overall impact of the treatment on their depression.
Participants are provided with information on the study's findings and any necessary follow-up care.

Who can join the trial?

15 criteria

Must be willing and able to give written permission to participate in the study.
Must be between 18 and 75 years old.
Must have at least moderate **major depressive disorder (MDD)**, which is a type of depression, based on medical records and assessments.
Must have **treatment-resistant depression (TRD)**, meaning they have not responded to at least two different depression treatments during the current episode.
Must have a score of 19 or higher on the **Hamilton Depression Rating Scale (HDRS)**, a tool used to measure depression severity, at the start of the study.
Must have a score of 4 or higher on the **Clinical Global Impression-Severity (CGI-S)** scale, which assesses the severity of mental illness, at the start of the study.
If currently taking antidepressant medications, must be willing and able to stop taking them gradually, following local guidelines, to avoid withdrawal symptoms.
Must be able and willing to follow all study requirements, including attending all study visits and completing necessary assessments.
Must be willing to avoid alcohol for 48 hours before certain study procedures.
Must be willing to avoid recreational drugs from the start until the end of the study. Occasional use of **cannabinoids** (substances found in cannabis) before the study is allowed if it does not lead to a substance use disorder.
Must allow their general doctor and any specialist to be informed about their participation in the study.
For the open label extension (OLE) part of the study, must have completed the initial CORE study.
For the OLE, must be willing and able to give written permission again.
For the OLE, must be willing to avoid alcohol for 48 hours before certain study procedures.
For the OLE, must be willing to avoid recreational drugs throughout the study.

Who cannot join the trial?

7 criteria

Individuals who do not have Treatment-Resistant Depression (TRD) cannot participate. TRD is a type of depression that does not improve after trying several treatments.
Participants must be within a certain age range, typically adults, to be eligible.
Both males and females can participate, but certain gender-specific conditions may exclude someone.
People who are considered part of a vulnerable population may be excluded. This term refers to groups who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
Individuals with certain medical conditions or who are taking specific medications that could interfere with the study may be excluded.
Participants must be able to provide informed consent, meaning they understand the study and agree to participate.
Anyone who has participated in another clinical trial recently may be excluded to avoid interference with the study results.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Central Institute of Mental Health
Verified
Mannheim, Germany
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Verified
Gdansk, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Responsive
Lodz, Poland

Trial locations

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Investigated drugs

BPL-003 is a medication being tested for its effectiveness in treating patients with depression that has not responded to other treatments. It is administered through the nose and is being studied to see how well it works and how safe it is when used alongside psychological support.

What is already known about the treatment

BPL-003 – This medication is administered intranasally and is currently being studied in clinical trials for its effectiveness and safety in treating individuals with treatment-resistant depression. It is in the investigational stage, with ongoing research to determine its potential benefits and risks. The main therapeutic indication for BPL-003 is treatment-resistant depression, a condition where patients do not respond to standard antidepressant therapies. At the molecular level, BPL-003 is believed to work by modulating neurotransmitter systems in the brain, although the exact mechanism is still under investigation. It is classified pharmacologically as a novel antidepressant agent.

Investigated diseases

Treatment-Resistant Depression – Treatment-Resistant Depression (TRD) is a form of major depressive disorder that does not respond to standard treatments, such as antidepressant medications and psychotherapy. Individuals with TRD continue to experience persistent depressive symptoms despite trying multiple treatment options. The condition can lead to significant impairment in daily functioning and quality of life. TRD may involve a complex interplay of genetic, biological, and environmental factors. The progression of TRD can vary, with some individuals experiencing chronic symptoms, while others may have periods of partial improvement. Understanding and addressing TRD requires a comprehensive approach to identify and manage the underlying factors contributing to the resistance to treatment.