BPL-003 Efficacy and Safety in Treatment Resistant Depression

Treatment Resistant Depression Clinical Trial

Official title:

A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003 in Patients With Treatment Resistant Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870540
• Other study ID #: BPL-003-201
• Status: Recruiting
• Phase: Phase 2
• Start date: September 14, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 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

This is a Phase 2 study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).

Description:

Approximately 225 eligible participants will be receive a single dose of either low, medium, or high doses BPL-003, given intranasally, with 8 weeks of follow-up assessments.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. At least moderate major depressive disorder.

2. Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments based on the MGH ATRQ assessment.

3. Hamilton Depression Rating Scale score =19 at Screening and Baseline.

4. CGI-S =4 at Screening and Baseline.

5. If currently taking antidepressant medications, willing and able to discontinue current antidepressants.

Exclusion Criteria:

1. Current or past 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, 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 or 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. History or current uncontrolled hypertension.

10. Seizure disorder or any seizure in the 2 years prior to Screening.

11. Has clinically significant results on ECG during the Screening.

12. Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing that in the investigator's opinion may interfere with the administration of the study medication.

13. Female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study.

14. Male participants who are sexually active and not willing to use adequate forms of contraception during the study.

Related Conditions & MeSH terms

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

Intervention

Drug:
• BPL-003
A single dose administered intranasally

Locations

Country	Name	City	State
Australia	Dept. of Psychiatry and School Psychological Sciences, Monash University	Clayton	Victoria
Australia	NeuroCentrix Research	Melbourne
Australia	Royal Melbourne Hospital, University of Melbourne	Parkville
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	OVID Clinic, Augmented Psychotherapy	Berlin
Germany	Department of Psychiatry, University Hospital Frankfurt	Frankfurt am Main
Germany	Central Institute of Mental Health, Dept. of Molecular Neuroimaging	Mannheim
Germany	Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14	Tubingen
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk
Poland	Department of Psychiatry, UCK	Gdansk
Poland	Klinika Inventiva	Tuszyn
Poland	Department of Pharmacology and Physiology of CNS	Warsaw
Spain	Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Parc Sanitari Sant Joan de Deu HD Numancia	Barcelona
Spain	Fundación de Investigación HM Hospital	Madrid
Spain	Centro de Salud Mental La Corredoria	Oviedo
Spain	Centro Salud San Juan	Salamanca
United Kingdom	Clerkenwell Health	London
United Kingdom	King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD)	London
United States	CenExel ACMR	Atlanta	Georgia
United States	CenExel HRI	Berlin	New Jersey
United States	UAB School of Public Health, Department of Health Behavior	Birmingham	Alabama
United States	CenExel iResearch	Decatur	Georgia
United States	Cedar Clinical Research	Draper	Utah
United States	Wholeness Center	Fort Collins	Colorado
United States	Segal Trials Center for Psychedelic and Cannabis Research	Lauderhill	Florida
United States	University of Wisconsin, Dept of Family Medicine & Community Health	Madison	Wisconsin
United States	New York State Psychiatric Institute	New York	New York
United States	AIM Trials	Plano	Texas
United States	Portland Psychotherapy	Portland	Oregon
United States	Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)	Rockville	Maryland
United States	Woodland Research Northwest	Rogers	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Beckley Psytech Limited

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)	High compared to low dose of BPL-003. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0-6.	4 weeks
Secondary	Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)	High compared to low dose of BPL-003. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0-6.	1 week
Secondary	Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)	Medium compared to low dose of BPL-003. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0-6.	4 weeks and 1 week
Secondary	Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse events		8 weeks
Secondary	Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory tests		8 weeks
Secondary	Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurements		8 weeks
Secondary	Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters compared		8 weeks
Secondary	Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior		8 weeks
Secondary	Plasma levels of 5-MeO-DMT and its metabolites		1 day