Evaluating BPL-003 for Treatment Resistant Depression

An Open-Label, Phase 2a Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression

This study is testing a new nasal treatment called BPL-003 to see if it can help people with depression who haven't found relief from other medications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beckley Psytech Limited (Industry-sponsored)
• Locations: 3 sites (Liverpool and 2 other locations)
• Trial ID: NCT05660642 on ClinicalTrials.gov

What this trial studies

This open-label, multi-centre Phase 2a study aims to assess the safety, tolerability, and pharmacodynamics of BPL-003, an intranasal treatment, in patients with treatment resistant depression. The study consists of two parts: the first part involves administering one of two single doses of BPL-003 to patients, while the second part involves two doses, both accompanied by psychological support. Participants will be monitored for 12 weeks in Part 1 and 10 weeks in Part 2 to evaluate the treatment's effects. The study includes patients who have not responded adequately to previous antidepressant therapies.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with major depressive disorder who have not responded to at least two prior antidepressant treatments.

Not a fit: Patients with severe psychiatric disorders such as schizophrenia or bipolar disorder will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients suffering from treatment resistant depression.

How similar studies have performed: Other studies exploring novel treatments for treatment resistant depression have shown promise, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed with Major Depressive Disorder.
2. 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.
3. Montgomery-Asberg Depression Rating Scale score ≥24 at Screening.
4. Clinical Global Impression - Severity ≥4 at Screening.
5. Willing and able to discontinue current pharmacological anti-depressant therapy.
6. 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 Criteria:

1. Current or history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
2. Current personality disorders.
3. First-degree family history of schizophrenia, bipolar disorder, delusional disorder, personality disorders or schizoaffective disorder.
4. Current alcohol or substance use disorder (other than caffeine or nicotine).
5. 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.
6. 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.
7. Suicide attempt and/or self-injurious behaviour within the last 12 months prior to Screening.
8. Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
9. Seizure disorder or history of seizures (including febrile seizures).
10. Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline.
11. 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.
12. Currently receiving lithium, antipsychotics, serotonergic drugs (excluding the permitted SSRIs for arm B), psychostimulants, or any other prohibited medication.
13. Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception.
14. Male patients who are sexually active and not willing to using adequate forms of contraception.

Where this trial is running

Liverpool and 2 other locations

• MAC Clinical Research — Liverpool, United Kingdom (Recruiting)
• Hammersmith Medicines Research — London, United Kingdom (Recruiting)
• King's College London, Clinical Trials Facility — London, United Kingdom (Completed)

Study contacts

• Study coordinator: Beckley Psytech Ltd

Conditions Treatment Resistant Depression