Actively Recruiting
An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
Led by Beckley Psytech Limited · Updated on 2025-11-28
64
Participants Needed
3
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 adequate pharmacological treatments in the past 5 years, including at least one during 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 discontinue current antidepressant medication
- For Arm B, on stable dose of one of the following SSRIs: citalopram, escitalopram, sertraline, or fluoxetine
You will not qualify if you...
- Current or history of schizophrenia, psychotic disorders, 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)
- Previous non-response to ketamine, esketamine, electroconvulsive therapy, vagal nerve stimulation, or deep brain stimulation
- Suicidal ideation with intent or suicidal behavior within 12 months prior to screening or dosing
- Suicide attempt or self-injurious behavior within 12 months prior to screening
- Uncontrolled medical conditions such as hypo/hyperthyroidism, diabetes, or renal failure
- History of seizures or seizure disorder
- Abnormal significant results on physical exam, vital signs, ECG, or lab tests at screening
- Nasal obstruction, blockage, or congestion that may interfere with drug administration
- Currently receiving lithium, antipsychotics, serotonergic drugs (except permitted SSRIs), psychostimulants, or prohibited medications
- Female patients who are pregnant, lactating, or of childbearing potential not using adequate contraception
- Male patients who are sexually active and not using adequate contraception
AI-Screening
AI-Powered Screening
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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
B
Beckley Psytech Ltd
CONTACT
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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