Treatment Resistant DepressionPhase 2NCT05660642
An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
A Phase 2 study testing BPL-003 in people with Treatment Resistant Depression, run by Beckley Psytech Limited at 3 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- BPL-003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 10 Feb 2023to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- 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.
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- Suicide attempt and/or self-injurious behaviour within the last 12 months prior to Screening.
- 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.
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 2 recruiting
- Recruiting
MAC Clinical Research
Liverpool, L34 1BH
0800 917 7637, info@researchforyou.co.uk
- Recruiting
Hammersmith Medicines Research
London
Study Coordinator, +44 (0)20 8961 4130, REC@hmrlondon.com
- Completed
King's College London, Clinical Trials Facility
London
About this study
Official title: 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).
Read the detailed description
Part 1: Up to 32 patients, across 2 parallel arms (Arms A and Arms B) will receive one of two single doses of BPL-003, given intranasally, with 12 weeks of follow-up assessments.
Part 2: Up to 40 patients, across 2 parallel arms (Arms A and Arms B) will receive two doses of BPL-003, given intranasally, with 10 weeks of follow-up assessments.
Psychological support will be given before, during and after dosing in Part 1 and Part 2.
- Conditions
- Treatment Resistant Depression
- Being tested
- BPL-003
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPL-003Drug
Experimental BPL-003 arms: will investigate one of two doses of BPL-003 (Part 1) and two doses of BPL-003 (Part 2)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: BPL-003 |
| Arm B | Experimental | Not described Receives: Drug: BPL-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To assess the safety and tolerability of single or multiple intranasal doses of BPL-003 in patients with treatment resistant depression
- Percentage of patients with treatment emergent adverse events
- Percentage of patients with clinically significant abnormal laboratory tests
- Percentage of patients with clinically significant abnormal vital signs
- Percentage of patients with clinically significant findings in physical examination
- Percentage of patients with clinically significant ECG parameters or cardiac telemetry abnormalities (Part 1 Arm B only)
- Percentage of patients with suicidal ideation or behaviour
Measured: Baseline to 12 weeks post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start10 Feb 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beckley Psytech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Craig, M.D., Study director, Beckley Psytech Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660642
- Sponsor's protocol ID
- BPL-003-204
- Status last verified
- May 2026
- First submitted
- 13 Dec 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 2a Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT05660642
- Acronym / sponsor ID
- BPL-003-204
- Conditions
- Treatment Resistant Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Beckley Psytech LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Part 1: Up to 32 patients, across 2 parallel arms (Arms A and Arms B) will receive one of two single doses of BPL-003, given intranasally, with 12 weeks of follow-up assessments.
Part 2: Up to 40 patients, across 2 parallel arms (Arms A and Arms B) will receive two doses of BPL-003, given intranasally, with 10 weeks of follow-up assessments.
Psychological support will be given before, during and after dosing in Part 1 and Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BPL-003 |
| Arm B | Experimental | Drug: BPL-003 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPL-003Experimental BPL-003 arms: will investigate one of two doses of BPL-003 (Part 1) and two doses of BPL-003 (Part 2) | Drug | Arm A, Arm B |
Primary outcome
1. To assess the safety and tolerability of single or multiple intranasal doses of BPL-003 in patients with treatment resistant depression
Time frame: Baseline to 12 weeks post dose
* Percentage of patients with treatment emergent adverse events * Percentage of patients with clinically significant abnormal laboratory tests * Percentage of patients with clinically significant abnormal vital signs * Percentage of patients with clinically significant findings in physical examination * Percentage of patients with clinically significant ECG parameters or cardiac telemetry abnormalities (Part 1 Arm B only) * Percentage of patients with suicidal ideation or behaviour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Craig, M.D. study director
Beckley Psytech Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BPL-003 in people with Treatment Resistant Depression, run by Beckley Psytech Limited at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Craig, M.D. (332-282-0507 ext. 1, clinicaltrials@ataibeckley.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To assess the safety and tolerability of single or multiple intranasal doses of BPL-003 in patients with treatment resistant depression (time frame: Baseline to 12 weeks post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.