Beckley Psytech Limited
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).
Treatment Resistant Depression
BPL-003
Phase 2
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.
Study Type : | Interventional |
Estimated Enrollment : | 225 participants |
Masking: | Triple |
Masking Description: | Quadruple masking: participant, Investigator, therapist, outcomes assessor and Sponsor |
Primary Purpose: | Treatment |
Official Title: | A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003 in Patients With Treatment Resistant Depression |
Actual Study Start Date : | September 14, 2023 |
Estimated Primary Completion Date : | October 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Low dose Active placebo comparator |
Drug: BPL-003 |
Experimental: Medium dose |
Drug: BPL-003 |
Experimental: High dose |
Drug: BPL-003 |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
UAB School of Public Health, Department of Health Behavior
Birmingham, Alabama, United States, 35222
Recruiting
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
Recruiting
Wholeness Center
Fort Collins, Colorado, United States, 80525
Recruiting
Segal Trials Center for Psychedelic and Cannabis Research
Lauderhill, Florida, United States, 33319
Recruiting
Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)
Rockville, Maryland, United States, 20850
Not yet recruiting
New York State Psychiatric Institute
New York, New York, United States, 10032
Recruiting
Portland Psychotherapy
Portland, Oregon, United States, 97227
Recruiting
AIM Trials
Plano, Texas, United States, 75093
Recruiting
Cedar Clinical Research
Draper, Utah, United States, 84020
Recruiting
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Recruiting
Dept. of Psychiatry and School Psychological Sciences, Monash University
Clayton, Victoria, Australia, 3168
Recruiting
Royal Melbourne Hospital, University of Melbourne
Parkville, Australia, 3050
Recruiting
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Recruiting
Central Institute of Mental Health, Dept. of Molecular Neuroimaging
Mannheim, Germany, 68159
Recruiting
Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14
Tubingen, Germany, 72076
Recruiting
Department of Psychiatry, UCK
Gdansk, Poland, 80-214
Recruiting
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, Poland, 80-546
Recruiting
Klinika Inventiva
Tuszyn, Poland, 95-080
Recruiting
Hospital del Mar
Barcelona, Spain, 08003
Recruiting
Parc Sanitari Sant Joan de Deu HD Numancia
Barcelona, Spain, 08029
Recruiting
Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.
Barcelona, Spain, 08036
Recruiting
Fundación de Investigación HM Hospital
Madrid, Spain, 28050
Recruiting
Centro de Salud Mental La Corredoria
Oviedo, Spain, 33011
Recruiting
Centro Salud San Juan
Salamanca, Spain, 37005
Recruiting
Clerkenwell Health
London, United Kingdom, W1G 8DR