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

Treatment Resistant Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660642
• Other study ID #: BPL-003-204
• Status: Recruiting
• Phase: Phase 2
• Start date: February 10, 2023
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Beckley Psytech Limited
• Contact: Beckley Psytech Ltd
• Phone: +44 (0)1865 987633
• Email: Medinfo[@]beckleypsytech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open-label, multi-centre, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamics of a single intranasal dose of 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, or sertraline).

Description:

Up to 52 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. Psychological support will be given before, during and after dosing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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 3 SSRIs (arm B), i.e. either citalopram, escitalopram, or sertraline.

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 behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.

7. Suicide attempt and/or self-injurious behavior 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Drug:
• BPL-003
Experimental BPL-003 arms: will investigate one of two doses of BPL-003

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London
United Kingdom	King's College London, Clinical Trials Facility	London

Sponsors (1)

Lead Sponsor	Collaborator
Beckley Psytech Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in MADRS		Day 2 to 12 weeks post dose
Other	Percentage of responders	Defined as 50% reduction in MADRS score compared to Baseline	Day 2 to 12 weeks post dose
Other	Percentage of patients in remission	Defined as MADRS score of <11	Day 2 to 12 weeks post dose
Other	Plasma levels of 5-MeO-DMT and its metabolite (bufotenine)		Day 1
Primary	To assess the safety and tolerability of a single intranasal dose 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 (Arm B only); Percentage of patients with suicidal ideation or behavior	Baseline to 12 weeks post dose