Treatment Resistant DepressionPhase 2NCT05870540

BPL-003 Efficacy and Safety in Treatment Resistant Depression

A Phase 2 study testing BPL-003 in people with Treatment Resistant Depression, run by Beckley Psytech Limited at 42 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Treatment Resistant Depression
What is being tested?: BPL-003
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 42 sitesin 6 countries
Study dates: 14 Sep 2023to 3 Jul 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

1. Other co-morbidities.

Trial locations and contacts

42 sites in 6 countries.

Country

City, postcode or hospital

42 sites in 6 countries

United States19 sites

Emory University, Brain Health Center, Department of Psychiatry and Behavioral Sciences
Atlanta, Georgia, 30329
CenExel ACMR
Atlanta, Georgia, 30331
CenExel HRI
Berlin, New Jersey, 08009
UAB School of Public Health, Department of Health Behavior
Birmingham, Alabama, 35209
Boston Clinical Trials
Boston, Massachusetts, 02131
CenExel iResearch
Decatur, Georgia, 30030
Insite clinical research
DeSoto, Texas, 75115
Cedar Clinical Research
Draper, Utah, 84020
Wholeness Center
Fort Collins, Colorado, 80525
Segal Trials Center for Psychedelic and Cannabis Research
Lauderhill, Florida, 33319
University of Wisconsin, Dept of Family Medicine & Community Health
Madison, Wisconsin, 53705
New York State Psychiatric Institute
New York, New York, 10032
AIM Trials
Plano, Texas, 75093
Portland Psychotherapy
Portland, Oregon, 97227
Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)
Rockville, Maryland, 20850
Woodland Research Northwest
Rogers, Arkansas, 72758
Kadima Neuropsychiatry Institute
San Diego, California, 92037
San Francisco Insight and Integration Center
San Francisco, California, 94114
Pacific Neuroscience Institute, Treatment and Research in Psychedelics (TRIP) Program
Santa Monica, California, 90404

Other trials in United States

Spain6 sites

Hospital del Mar
Barcelona, 08003
Parc Sanitari Sant Joan de Deu HD Numancia
Barcelona, 08029
Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.
Barcelona, 08036
Fundación de Investigación HM Hospital
Madrid, 28050
Centro de Salud Mental La Corredoria
Oviedo, 33011
Centro Salud San Juan
Salamanca, 37005

Other trials in Spain

Germany5 sites

Charité - Universitätsmedizin Berlin
Berlin, 10117
OVID Clinic, Augmented Psychotherapy
Berlin, 10247
Department of Psychiatry, University Hospital Frankfurt
Frankfurt am Main, 60528
Central Institute of Mental Health, Dept. of Molecular Neuroimaging
Mannheim, 68159
Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14
Tübingen, 72076

Other trials in Germany

Poland5 sites

Department of Psychiatry, UCK
Gdansk, 80-214
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, 92-216
Klinika Inventiva
Tuszyn, 95-080
Department of Pharmacology and Physiology of CNS
Warsaw, 02-957

Other trials in Poland

Australia4 sites

Dept. of Psychiatry and School Psychological Sciences, Monash University
Clayton, Victoria, 3168
NeuroCentrix Research
Melbourne, 3053
Royal Melbourne Hospital, University of Melbourne
Parkville, 3050
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050

Other trials in Australia

United Kingdom3 sites

NIHR Exeter Clinical Research Facility
Exeter, EX2 5DW
King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD)
London, SE5 8AF
Clerkenwell Health
London, W1G 8DR

Other trials in United Kingdom

About this study

Official title: 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

Read the 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.

Conditions: Treatment Resistant Depression
Being tested: BPL-003
Medical subject headings: Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BPL-003Drug
A single dose administered intranasally
BPL-003Drug
A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)

Study groups in NCT05870540
Study group	Role	What they receive
Low dose (sub-therapeutic)	Experimental	Active placebo comparator Receives: Drug: BPL-003
Medium dose	Experimental	Not described Receives: Drug: BPL-003
High dose	Experimental	Not described Receives: Drug: BPL-003
Monophasic	Experimental	Not described Receives: Drug: BPL-003
Biphasic	Experimental	Not described Receives: Drug: BPL-003

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 8 weeks

Secondary outcomes (4)

Core: Change From Baseline in MADRS Total Score at Day 8 (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 8 was assessed.
Measured: 1 week
Core: Change From Baseline in MADRS Total Score at Day 29 (8 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 8 mg (medium dose) vs 0.3 mg (low dose) BPL-003 at Day 29 was assessed.
Measured: 4 weeks
Core: Change From Baseline in MADRS Total Score at Day 8 (8 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 8 mg (medium dose) vs 0.3 mg (low dose) BPL-003 at Day 8 was assessed.
Measured: 1 week
Core: Number of Participants With Treatment-emergent Adverse Events in the Core Trial Period
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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 20233 Jul 2025

First posted23 May 2023
Study start14 Sep 2023
Primary completion28 Mar 2025
Study completion3 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 196 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05870540
Sponsor's protocol ID: BPL-003-201
Status last verified: Apr 2025
First submitted: 12 May 2023
Last updated: 10 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Due to the GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion

Publications

Feifel D, Seynaeve M, Cubala WJ, Dunbar F, Grunder G, Duenas Herrero RM, Hindocha C, Liknaitzky P, McGuigan SM, Mehta S, Pierce M, Repantis D, Roberts C, Wiegand F, Conley R. Single Intranasal Administration of the Psychedelic Mebufotenin for Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA. 2026 Oct 26:e2618380. doi: 10.1001/jama.2026.18380. Online ahead of print.
PubMed 42931733

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression

All Treatment Resistant Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05870540
Acronym / sponsor ID: BPL-003-201
Conditions: Treatment Resistant Depression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 196 participants (actual)
Lead sponsor: Beckley Psytech LimitedIndustry (pharma, biotech, devices)
Study start: 14 Sep 2023 (actual)
Primary completion: 28 Mar 2025 (actual)
Study completion: 3 Jul 2025 (actual)
First posted: 23 May 2023 (actual)
Results: Posted 10 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Low dose (sub-therapeutic)	Experimental	Drug: BPL-003Active placebo comparator
Medium dose	Experimental	Drug: BPL-003
High dose	Experimental	Drug: BPL-003
Monophasic	Experimental	Drug: BPL-003
Biphasic	Experimental	Drug: BPL-003

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

1. Other co-morbidities.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BPL-003A single dose administered intranasally	Drug	High dose, Low dose (sub-therapeutic), Medium dose, Monophasic
BPL-003A single dose administered intranasally (administered as 2 nasal sprays, 10 minutes apart)	Drug	Biphasic

Primary outcome

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.
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.

4 secondary outcomes

Core: Change From Baseline in MADRS Total Score at Day 8 (12 mg vs 0.3 mg BPL-003)
Time frame: 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
Core: Change From Baseline in MADRS Total Score at Day 8 (8 mg vs 0.3 mg BPL-003)
Time frame: 1 week
Core: Number of Participants With Treatment-emergent Adverse Events in the Core Trial Period
Time frame: 8 weeks

Results and safety

Results posted to the registry on 10 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Core: Low Dose (0.3 mg)	74	64
Core: Medium Dose (8 mg)	46	41
Core: High Dose (12 mg)	73	69
OLE: Monophasic Dosing (12 mg)	0	0
OLE: Biphasic Dosing (4 mg and 8 mg)	0	0

Primary outcome: 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. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Core: Low Dose (0.3 mg) n = 68	Core: High Dose (12 mg) n = 68
Value	-5.8 (1.28)	-11.2 (1.27)

Core: Low Dose (0.3 mg) vs Core: High Dose (12 mg): Least square means: -5.3 (95% CI -8.9 to -1.8), p = 0.0033, Mixed Models Analysis

Population analysed: Data shown are for the FAS, which included all randomized participants who received the trial medication. Data are shown for all participants who had data available at the respective time points.

Primary outcome: OLE: Number of Participants With Treatment-emergent Adverse Events in the OLE

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	OLE: Monophasic Dosing (12 mg) n = 53	OLE: Biphasic Dosing (12 mg) n = 54
Value	46	46

Population analysed: Safety analysis set: all randomized participants who received any trial medication.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Core period: 8 weeks; OLE period: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Core: Low Dose (0.3 mg)	1 of 74 (1.4%)	54 of 74 (73%)	0 of 74
Core: Medium Dose (8 mg)	1 of 46 (2.2%)	35 of 46 (76.1%)	0 of 46
Core: High Dose (12 mg)	0 of 73 (0%)	62 of 73 (84.9%)	0 of 73
OLE: Monophasic Dosing (12 mg)	2 of 53 (3.8%)	46 of 53 (86.8%)	0 of 53
OLE: Biphasic Dosing (4 mg or 12 mg)	1 of 54 (1.9%)	39 of 54 (72.2%)	0 of 54

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42931733Feifel D, Seynaeve M, Cubala WJ, Dunbar F, Grunder G, Duenas Herrero RM, Hindocha C, Liknaitzky P, McGuigan SM, Mehta S, Pierce M, Repantis D, Roberts C, Wiegand F, Conley R. Single Intranasal Administration of the Psychedelic Mebufotenin for Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA. 2026 Oct 26:e2618380. doi: 10.1001/jama.2026.18380. Online ahead of print.
Individual participant dataSharing planned: No. Due to the GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion

Related trials for Treatment Resistant Depression

RecruitingPhase 4
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Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
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CET- REM (Correlating ECT Response to EEG Markers)
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A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kevin Craig, M.D. study director

Beckley Psytech Ltd

42 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BPL-003 in people with Treatment Resistant Depression, run by Beckley Psytech Limited at 42 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Spain, Germany, Poland, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05870540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.