Actively Recruiting
An Open-Label, Phase 2a Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
Led by Beckley Psytech Limited · Updated on 2026-05-26
64
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacodynamics of one or two doses of BPL-003, given intranasally, in patients with treatment resistant depression. This open-label, Phase 2a study includes participants who may receive BPL-003 alone or alongside specific SSRIs (citalopram, escitalopram, sertraline, or fluoxetine). Psychological support is provided before, during, and after dosing to assist participants throughout the treatment. The study has two parts: Part 1 involves up to 32 patients receiving a single dose of BPL-003 across two parallel groups, with 12 weeks of follow-up; Part 2 also includes up to 32 patients receiving two doses of BPL-003, with 10 weeks of follow-up. Both parts provide psychological support throughout the dosing and follow-up periods. Participants will undergo safety and tolerability assessments, including clinical evaluations and monitoring of pharmacodynamics from baseline through follow-up. Researchers will track all relevant measures over 10 to 12 weeks after dosing to understand how BPL-003 affects treatment resistant depression and assess any side effects or issues during the study period.
CONDITIONS
Brief Title
An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Major Depressive Disorder
- Diagnosed with treatment resistant depression defined as failure to respond to at least 2 pharmacological treatments in the past 5 years, including the current episode
- Montgomery-Asberg Depression Rating Scale score of 24 or higher at screening
- Clinical Global Impression - Severity score of 4 or higher at screening
- Willing and able to stop current antidepressant therapy
- On a stable dose of one of the following SSRIs: citalopram, escitalopram, sertraline, or fluoxetine (for Arm B)
You will not qualify if you...
- Current or history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, schizoaffective disorder, or other severe psychiatric disorders
- Current personality disorders
- First-degree family history of schizophrenia, bipolar disorder, delusional disorder, personality disorders, or schizoaffective disorder
- Current alcohol or substance use disorder (except caffeine or nicotine)
- Unresponsive to ketamine, esketamine, electroconvulsive therapy, vagal nerve stimulation, or deep brain stimulation
- Suicidal ideation with intent or suicidal behavior within 12 months before screening or Day 1
- Suicide attempt or self-injurious behavior within 12 months before screening
- Uncontrolled medical conditions such as thyroid disorders, diabetes, or renal failure
- Seizure disorder or history of seizures including febrile seizures
- Abnormal findings on physical exam, vital signs, ECG, or lab tests at screening
- Nasal obstruction or congestion that may interfere with drug administration
- Currently taking lithium, antipsychotics, serotonergic drugs (except permitted SSRIs), psychostimulants, or other prohibited medications
- Female participants who are pregnant, breastfeeding, or of childbearing potential not using contraception
- Male participants who are sexually active and not using contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single dose with 12 weeks of follow-up in Part 1; two doses with 10 weeks of follow-up in Part 2
Participants receive one or two intranasal doses of the experimental drug BPL-003, depending on their assigned arm.
1 or 2 dosing visits depending on study part and arm, plus multiple follow-up visits over 10 to 12 weeks
Trial Site Locations
Total: 3 locations
1
MAC Clinical Research
Liverpool, United Kingdom, L34 1BH
Actively Recruiting
2
Hammersmith Medicines Research
London, United Kingdom
Actively Recruiting
3
King's College London, Clinical Trials Facility
London, United Kingdom
Completed
Research Team
K
Kevin Craig, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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