BPL-003 Efficacy and Safety in Treatment Resistant Depression

NCT05870540 | Completed Phase 2 Results 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 trial with an open-label extension (OLE), designed to investigate the efficacy and safety of BPL-003 in patients with treatment resistant depression (TRD).

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  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 Outcomes (4)

• Core: Change From Baseline in MADRS Total Score at Day 8 (12 mg vs 0.3 mg BPL-003)

  1 week

• Core: Change From Baseline in MADRS Total Score at Day 29 (8 mg vs 0.3 mg BPL-003)

  4 weeks

• Core: Change From Baseline in MADRS Total Score at Day 8 (8 mg vs 0.3 mg BPL-003)

  1 week

• Core: Number of Participants With Treatment-emergent Adverse Events in the Core Trial Period

  8 weeks

Study Arms (5)

Low dose (sub-therapeutic)

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 (sub-therapeutic); 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:

• Diagnosis of TRD.
• History consistent with TRD.
• 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).
• Willing and able to discontinue current antidepressants, if applicable.

You may not qualify if:

• \. Other co-morbidities.

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

Limitations and Caveats

Core randomization was 1:1:1 and was modified to 3:1:3 in protocol version 3.0 (17 May 24) to enable recruitment to complete, reducing trial numbers from 225 to 203 participants. This reduced the numbers in the 8 mg arm but maintained the numbers in the 0.3 mg and 12 mg arms, preserving the power of the primary endpoint comparison. Overall randomization allocation ratio averaged to approximately 3:2:3. 5 SAEs reported, only 1 (suicidal ideation) was considered related to study drug.

Results Point of Contact

• Title: Ian Macleod
• Organization: AtaiBeckley Inc.

clinicaltrials@ataibeckley.com

+1 (332) 282-0507

Study Officials

• Kevin Craig, M.D.

  Beckley Psytech Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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, 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: September 10, 2026
• Results First Posted: September 10, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

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