Tests BPL-003 nasal spray for treatment resistant depression in adults
Tests BPL-003, a nasal spray, in adults with depression that has not responded to treatment.
Plain-language title generated from the registry record
Registry title: An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
Key facts
- Where
- Liverpool and London, United KingdomSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05660642, who can take part
Where in United Kingdom
- MAC Clinical ResearchLiverpool, United KingdomTaking people
- Hammersmith Medicines ResearchLondon, United KingdomTaking people
- King's College London, Clinical Trials FacilityLondon, United KingdomNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beckley Psytech Limited
- Trial code
- NCT05660642
- Record updated
- 6 July 2026
- Original description
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).Read full original descriptionShow less
An Open-Label, Phase 2a Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
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).
Inclusion: Diagnosed with Major Depressive Disorder; Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments in the past 5 years prior to screening, at least one of which is during the current episode; Montgomery-Asberg Depression Rating Scale score ≥24 at Screening; Clinical Global Impression - Severity ≥4 at Screening; Willing and able to discontinue current pharmacological anti-depressant therapy; On current stable dose of pharmacological antidepressant therapy limited to one of 4 SSRIs (Arm B), i.e. either citalopram, escitalopram, sertraline or fluoxetine.
Exclusion: A participant who at any time, has been unresponsive to ketamine, esketamine, an adequate course of treatment with electroconvulsive therapy, or has received vagal nerve stimulation or deep brain stimulation; Suicidal ideation with the intent to act or suicidal behaviour within the 12 months prior to the start of Screening or on Day 1 prior to dosing; Suicide attempt and/or self-injurious behaviour within the last 12 months prior to Screening; Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing, that in the Investigator's opinion may interfere with administration of the study drug; Currently receiving lithium, antipsychotics, serotonergic drugs (excluding the permitted SSRIs for arm B), psychostimulants, or any other prohibited medication; Current or history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder; Current personality disorders; First-degree family history of schizophrenia, bipolar disorder, delusional disorder, personality disorders or schizoaffective disorder; Current alcohol or substance use disorder (other than caffeine or nicotine); Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure; Seizure disorder or history of seizures (including febrile seizures); Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline; Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception; Male patients who are sexually active and not willing to using adequate forms of contraception.