BPL-003 Efficacy and Safety in Treatment Resistant Depression
NCT ID: NCT05870540
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
196 participants
INTERVENTIONAL
2023-09-14
2025-07-03
Brief Summary
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Detailed Description
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Psychological support will be given before, during and after each dosing.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
OLE: Open Label Extension.
Study Groups
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Low dose
Active placebo comparator
BPL-003
A single dose administered intranasally
Medium dose
BPL-003
A single dose administered intranasally
High dose
BPL-003
A single dose administered intranasally
Monophasic
BPL-003
A single dose administered intranasally
Biphasic
BPL-003
A single dose administered intranasally (administered as 2 nasal sprays minutes apart)
Interventions
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BPL-003
A single dose administered intranasally
BPL-003
A single dose administered intranasally (administered as 2 nasal sprays minutes apart)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Beckley Psytech Limited
INDUSTRY
Responsible Party
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Principal Investigators
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VP & Head of Clinical Development
Role: STUDY_DIRECTOR
Beckley Psytech Ltd
Locations
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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
Countries
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Other Identifiers
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BPL-003-201
Identifier Type: -
Identifier Source: org_study_id
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