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BPL-003 Efficacy and Safety in Treatment Resistant Depression
Sponsor: Beckley Psytech Limited
Summary
This is a Phase 2 study randomized, quadruple-masked, multi-center trial with an open-label extension (OLE), designed to investigate the efficacy and safety of BPL-003 in patients with treatment resistant depression (TRD).
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
196
Start Date
2023-09-14
Completion Date
2025-07-03
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
BPL-003
A single dose administered intranasally
BPL-003
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
Locations (42)
UAB School of Public Health, Department of Health Behavior
Birmingham, Alabama, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Kadima Neuropsychiatry Institute
San Diego, California, United States
San Francisco Insight and Integration Center
San Francisco, California, United States
Pacific Neuroscience Institute, Treatment and Research in Psychedelics (TRIP) Program
Santa Monica, California, United States
Wholeness Center
Fort Collins, Colorado, United States
Segal Trials Center for Psychedelic and Cannabis Research
Lauderhill, Florida, United States
Emory University, Brain Health Center, Department of Psychiatry and Behavioral Sciences
Atlanta, Georgia, United States
CenExel ACMR
Atlanta, Georgia, United States
CenExel iResearch
Decatur, Georgia, United States
Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)
Rockville, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
CenExel HRI
Berlin, New Jersey, United States
New York State Psychiatric Institute
New York, New York, United States
Portland Psychotherapy
Portland, Oregon, United States
Insite clinical research
DeSoto, Texas, United States
AIM Trials
Plano, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
University of Wisconsin, Dept of Family Medicine & Community Health
Madison, Wisconsin, United States
Royal Prince Alfred Hospital
Sydney, New South Wales, 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
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
Tübingen, Germany
Department of Psychiatry, UCK
Gdansk, Poland
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, Poland
Klinika Inventiva
Tuszyn, Poland
Department of Pharmacology and Physiology of CNS
Warsaw, Poland
Hospital del Mar
Barcelona, Spain
Parc Sanitari Sant Joan de Deu HD Numancia
Barcelona, Spain
Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.
Barcelona, Spain
Fundación de Investigación HM Hospital
Madrid, Spain
Centro de Salud Mental La Corredoria
Oviedo, Spain
Centro Salud San Juan
Salamanca, Spain
NIHR Exeter Clinical Research Facility
Exeter, United Kingdom
King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD)
London, United Kingdom
Clerkenwell Health
London, United Kingdom