Clinical trial NCT05870540: BPL-003 Efficacy and Safety in Treatment Resistant Depression
Official title: A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003, With Open Label Extension, in Patients With Treatment-Resistant Depression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Treatment Resistant Depression
Lead sponsor: Beckley Psytech Limited
Sponsor class: INDUSTRY
First posted: 2023-05-23
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Approximately 200 eligible participants will receive a single dose of either low, medium, or high doses of BPL-003, given intranasally, with 8 weeks of follow up assessments. Following this participants may receive a second dose of either monophasic or biphasic dose of BPL-003, given intranasally, with another 8 weeks of follow up assessments.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 4 weeks
measure: OLE Primary Safety Outcome Measure
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 1 week
measure: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 4 weeks and 1 week
measure: Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse events
timeFrame: 8 weeks
measure: Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory tests
timeFrame: 8 weeks
measure: Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurements
timeFrame: 8 weeks
measure: Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters compared
timeFrame: 8 weeks
measure: Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior
timeFrame: 8 weeks
measure: Plasma levels of 5-MeO-DMT and its metabolites
timeFrame: 1 day
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Public Health, Department of Health Behavior
state: Alabama
city: Rogers
country: United States
facility: Woodland Research Northwest
state: Arkansas
city: San Diego
country: United States
facility: Kadima Neuropsychiatry Institute
state: California
city: San Francisco
country: United States
facility: San Francisco Insight and Integration Center
state: California
city: Santa Monica
country: United States
facility: Pacific Neuroscience Institute, Treatment and Research in Psychedelics (TRIP) Program
state: California
city: Fort Collins
country: United States
facility: Wholeness Center
state: Colorado
city: Lauderhill
country: United States
facility: Segal Trials Center for Psychedelic and Cannabis Research
state: Florida
city: Atlanta
country: United States
facility: Emory University, Brain Health Center, Department of Psychiatry and Behavioral Sciences
state: Georgia
city: Atlanta
country: United States
facility: CenExel ACMR
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch
state: Georgia
city: Rockville
country: United States
facility: Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Berlin
country: United States
facility: CenExel HRI
state: New Jersey
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: Portland
country: United States
facility: Portland Psychotherapy
state: Oregon
city: DeSoto
country: United States
facility: Insite clinical research
state: Texas
city: Plano
country: United States
facility: AIM Trials
state: Texas
city: Draper
country: United States
facility: Cedar Clinical Research
state: Utah
city: Madison
country: United States
facility: University of Wisconsin, Dept of Family Medicine & Community Health
state: Wisconsin
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Clayton
country: Australia
facility: Dept. of Psychiatry and School Psychological Sciences, Monash University
state: Victoria
city: Melbourne
country: Australia
facility: NeuroCentrix Research
city: Parkville
country: Australia
facility: Royal Melbourne Hospital, University of Melbourne
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: OVID Clinic, Augmented Psychotherapy
city: Frankfurt am Main
country: Germany
facility: Department of Psychiatry, University Hospital Frankfurt
city: Mannheim
country: Germany
facility: Central Institute of Mental Health, Dept. of Molecular Neuroimaging
city: Tubingen
country: Germany
facility: Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14
city: Gdansk
country: Poland
facility: Department of Psychiatry, UCK
city: Gdansk
country: Poland
facility: Centrum Badań Klinicznych PI-House sp. z o.o.
city: Lodz
country: Poland
facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
city: Tuszyn
country: Poland
facility: Klinika Inventiva
city: Warsaw
country: Poland
facility: Department of Pharmacology and Physiology of CNS
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Parc Sanitari Sant Joan de Deu HD Numancia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.
city: Madrid
country: Spain
facility: Fundación de Investigación HM Hospital
city: Oviedo
country: Spain
facility: Centro de Salud Mental La Corredoria
city: Salamanca
country: Spain
facility: Centro Salud San Juan
city: Exeter
country: United Kingdom
facility: NIHR Exeter Clinical Research Facility
city: London
country: United Kingdom
facility: King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD)
city: London
country: United Kingdom
facility: Clerkenwell Health
Study officials:
affiliation: Beckley Psytech Ltd
name: VP & Head of Clinical Development
role: STUDY_DIRECTOR
References: