BPL-003 Efficacy and Safety in Treatment Resistant Depression

NCT05870540 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: BPL-003-201
• Study Type: interventional
• Target: 196
• Locations: 6 countries
• Sites: 42

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).

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (2)

• 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

• OLE Primary Safety Outcome Measure

  To determine the safety of a second dose of BPL-003 given with psychological support to participants with TRD as assessed by treatment-emergent adverse events.

  8 weeks

Secondary Outcomes (8)

• Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

  1 week

• Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)

  4 weeks and 1 week

• Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse events

  8 weeks

• Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory tests

  8 weeks

• Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurements

  8 weeks

Study Arms (5)

Low dose

EXPERIMENTAL

Active placebo comparator

Drug: BPL-003

Medium dose

EXPERIMENTAL

Drug: BPL-003

High dose

EXPERIMENTAL

Drug: BPL-003

Monophasic

EXPERIMENTAL

Drug: BPL-003

Biphasic

EXPERIMENTAL

Drug: BPL-003

Interventions

BPL-003 DRUG

A single dose administered intranasally

High dose; Low dose; Medium dose; Monophasic

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least moderate major depressive disorder.
• 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.
• Hamilton Depression Rating Scale score ≥19 at Screening and Baseline.
• CGI-S ≥4 at Screening and Baseline.
• If currently taking antidepressant medications, willing and able to discontinue current antidepressants.

You may not qualify if:

• Current or past history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
• Current personality disorders.
• First-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder.
• Current alcohol or substance use disorder (other than caffeine or nicotine).
• 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.
• Suicidal ideation or behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
• Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.
• Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
• History or current uncontrolled hypertension.
• Seizure disorder or any seizure in the 2 years prior to Screening.
• Has clinically significant results on ECG during the Screening.
• 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.
• Female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study.
• Male participants who are sexually active and not willing to use adequate forms of contraception during the study.

Sponsors & Collaborators

• Beckley Psytech Limited: lead

Study Sites (42)

UAB School of Public Health, Department of Health Behavior

Birmingham, Alabama, 35209, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Kadima Neuropsychiatry Institute

San Diego, California, 92037, United States

Location

San Francisco Insight and Integration Center

San Francisco, California, 94114, United States

Location

Pacific Neuroscience Institute, Treatment and Research in Psychedelics (TRIP) Program

Santa Monica, California, 90404, United States

Location

Wholeness Center

Fort Collins, Colorado, 80525, United States

Location

Segal Trials Center for Psychedelic and Cannabis Research

Lauderhill, Florida, 33319, United States

Location

Emory University, Brain Health Center, Department of Psychiatry and Behavioral Sciences

Atlanta, Georgia, 30329, United States

Location

CenExel ACMR

Atlanta, Georgia, 30331, United States

Location

CenExel iResearch

Decatur, Georgia, 30030, United States

Location

Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)

Rockville, Maryland, 20850, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

CenExel HRI

Berlin, New Jersey, 08009, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Portland Psychotherapy

Portland, Oregon, 97227, United States

Location

Insite clinical research

DeSoto, Texas, 75115, United States

Location

AIM Trials

Plano, Texas, 75093, United States

Location

Cedar Clinical Research

Draper, Utah, 84020, United States

Location

University of Wisconsin, Dept of Family Medicine & Community Health

Madison, Wisconsin, 53705, United States

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Dept. of Psychiatry and School Psychological Sciences, Monash University

Clayton, Victoria, 3168, Australia

Location

NeuroCentrix Research

Melbourne, 3053, Australia

Location

Royal Melbourne Hospital, University of Melbourne

Parkville, 3050, Australia

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

OVID Clinic, Augmented Psychotherapy

Berlin, 10247, Germany

Location

Department of Psychiatry, University Hospital Frankfurt

Frankfurt am Main, 60528, Germany

Location

Central Institute of Mental Health, Dept. of Molecular Neuroimaging

Mannheim, 68159, Germany

Location

Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14

Tübingen, 72076, Germany

Location

Department of Psychiatry, UCK

Gdansk, 80-214, Poland

Location

Centrum Badań Klinicznych PI-House sp. z o.o.

Gdansk, 80-546, Poland

Location

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 92-216, Poland

Location

Klinika Inventiva

Tuszyn, 95-080, Poland

Location

Department of Pharmacology and Physiology of CNS

Warsaw, 02-957, Poland

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Parc Sanitari Sant Joan de Deu HD Numancia

Barcelona, 08029, Spain

Location

Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.

Barcelona, 08036, Spain

Location

Fundación de Investigación HM Hospital

Madrid, 28050, Spain

Location

Centro de Salud Mental La Corredoria

Oviedo, 33011, Spain

Location

Centro Salud San Juan

Salamanca, 37005, Spain

Location

NIHR Exeter Clinical Research Facility

Exeter, EX2 5DW, United Kingdom

Location

King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD)

London, SE5 8AF, United Kingdom

Location

Clerkenwell Health

London, W1G 8DR, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• VP & Head of Clinical Development

  Beckley Psytech Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: CORE: Quadruple masking: participant, Investigator, therapist, outcomes assessor and Sponsor. OLE: Open Label Extension.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: September 14, 2023
• Primary Completion: March 28, 2025
• Study Completion: July 3, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); DE (5); AU (4); PL (5); ES (6); GB (3)