BPL-003 Efficacy and Safety in Treatment Resistant Depression

August 18, 2026 updated by: Beckley Psytech Limited

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the main part of the trial, approximately 200 eligible participants will receive a either a low (sub-therapeutic), medium, or high single dose of BPL-003, given intranasally, with 8 weeks of follow-up assessments.

Following this, participants may receive a second high dose of BPL-003 during the OLE, given intranasally as either a single spray or two sprays 10 minutes apart, with another 8 weeks of follow-up assessments.

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

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3053
        • NeuroCentrix Research
      • Parkville, Australia, 3050
        • Royal Melbourne Hospital, University of Melbourne
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Dept. of Psychiatry and School Psychological Sciences, Monash University
  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 10247
        • OVID Clinic, Augmented Psychotherapy
      • Frankfurt am Main, Germany, 60528
        • Department of Psychiatry, University Hospital Frankfurt
      • Mannheim, Germany, 68159
        • Central Institute of Mental Health, Dept. of Molecular Neuroimaging
      • Tübingen, Germany, 72076
        • Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14
  • Poland
      • Gdansk, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
      • Gdansk, Poland, 80-214
        • Department of Psychiatry, UCK
      • Lodz, Poland, 92-216
        • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
      • Tuszyn, Poland, 95-080
        • Klinika Inventiva
      • Warsaw, Poland, 02-957
        • Department of Pharmacology and Physiology of CNS
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08029
        • Parc Sanitari Sant Joan de Deu HD Numancia
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.
      • Madrid, Spain, 28050
        • Fundación de Investigación HM Hospital
      • Oviedo, Spain, 33011
        • Centro de Salud Mental La Corredoria
      • Salamanca, Spain, 37005
        • Centro Salud San Juan
  • United Kingdom
      • Exeter, United Kingdom, EX2 5DW
        • NIHR Exeter Clinical Research Facility
      • London, United Kingdom, W1G 8DR
        • Clerkenwell Health
      • London, United Kingdom, SE5 8AF
        • King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • UAB School of Public Health, Department of Health Behavior
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Woodland Research Northwest
    • California
      • San Diego, California, United States, 92037
        • Kadima Neuropsychiatry Institute
      • San Francisco, California, United States, 94114
        • San Francisco Insight and Integration Center
      • Santa Monica, California, United States, 90404
        • Pacific Neuroscience Institute, Treatment and Research in Psychedelics (TRIP) Program
    • Colorado
      • Fort Collins, Colorado, United States, 80525
        • Wholeness Center
    • Florida
      • Lauderhill, Florida, United States, 33319
        • Segal Trials Center for Psychedelic and Cannabis Research
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • CenExel ACMR
      • Atlanta, Georgia, United States, 30329
        • Emory University, Brain Health Center, Department of Psychiatry and Behavioral Sciences
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • CenExel HRI
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute
    • Oregon
      • Portland, Oregon, United States, 97227
        • Portland Psychotherapy
    • Texas
      • DeSoto, Texas, United States, 75115
        • Insite clinical research
      • Plano, Texas, United States, 75093
        • AIM Trials
    • Utah
      • Draper, Utah, United States, 84020
        • Cedar Clinical Research
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin, Dept of Family Medicine & Community Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Diagnosis of TRD.
  2. History consistent with TRD.
  3. Current depressive episode which is at least moderate in severity (Hamilton Depression Rating Scale score is ≥19 and Clinical Global Impression-Severity score is ≥4).
  4. Willing and able to discontinue current antidepressants, if applicable.

Exclusion criteria:

1. Other co-morbidities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose
Drug: BPL-003
A single dose administered intranasally
Drug: BPL-003
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
Experimental: Medium dose
Drug: BPL-003
A single dose administered intranasally
Drug: BPL-003
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
Experimental: Monophasic
Drug: BPL-003
A single dose administered intranasally
Drug: BPL-003
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
Experimental: Biphasic
Drug: BPL-003
A single dose administered intranasally
Drug: BPL-003
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)
Experimental: Low dose (sub-therapeutic)
Active placebo comparator
Drug: BPL-003
A single dose administered intranasally
Drug: BPL-003
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core: Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Day 29 (12 mg vs 0.3 mg BPL-003)
Time Frame: 4 weeks

The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60.

The change from baseline in MADRS total score for 12 mg (high dose) vs 0.3 mg (low dose) BPL-003 at Day 29 was assessed.
4 weeks
OLE: Number of Participants With Treatment-emergent Adverse Events in the OLE
Time Frame: 8 weeks
The safety of a second dose of BPL-003 given with psychological support to participants with TRD was assessed by the number and percentage of participants with treatment-emergent adverse events.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core: Change From Baseline in MADRS Total Score at Day 8 (12 mg vs 0.3 mg BPL-003)
Time Frame: 1 week

The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60.

The change from baseline in MADRS total score for 12 mg (high dose) vs 0.3 mg (low dose) BPL-003 at Day 8 was assessed.
1 week
Core: Change From Baseline in MADRS Total Score at Day 29 (8 mg vs 0.3 mg BPL-003)
Time Frame: 4 weeks

The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60.

The change from baseline in MADRS total score for 8 mg (medium dose) vs 0.3 mg (low dose) BPL-003 at Day 29 was assessed.
4 weeks
Core: Change From Baseline in MADRS Total Score at Day 8 (8 mg vs 0.3 mg BPL-003)
Time Frame: 1 week

The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS was administered remotely throughout the trial by independent, centralized, qualified raters. The rater used the SIGMA to interview the participant, moving from broadly based questions about symptoms to more detailed questions that allowed the precise rating of symptom severity. The SIGMA provides structured probes to ensure standardization of administration and comprehensiveness of coverage of the 10 items of the scale. A higher MADRS score indicates more severe depression, with each item yielding a score of 0-6. Total overall scores therefore range from 0-60.

The change from baseline in MADRS total score for 8 mg (medium dose) vs 0.3 mg (low dose) BPL-003 at Day 8 was assessed.
1 week
Core: Number of Participants With Treatment-emergent Adverse Events in the Core Trial Period
Time Frame: 8 weeks
The safety of BPL-003 given with psychological support to participants with TRD was assessed by the number and percentage of participants with treatment-emergent adverse events. Any clinically significant findings during the trial have been included as adverse events.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beckley Psytech Limited

Investigators

  • Study Director: Kevin Craig, M.D., Beckley Psytech Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2023

Primary Completion (Actual)

March 28, 2025

Study Completion (Actual)

July 3, 2025

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPL-003-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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