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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

NCT ID NCT05870540

NEW Sponsor: Beckley Psytech Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

196 people

The number who actually took part.

Started

Sep 2023

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Treatment resistant depression

Contacts and locations

Locations

  • AIM Trials

    Plano, Texas, 75093, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • Cedar Clinical Research

    Draper, Utah, 84020, United States

  • CenExel ACMR

    Atlanta, Georgia, 30331, United States

  • CenExel HRI

    Berlin, New Jersey, 08009, United States

  • CenExel iResearch

    Decatur, Georgia, 30030, United States

  • Central Institute of Mental Health, Dept. of Molecular Neuroimaging

    Mannheim, 68159, Germany

  • Centro Salud San Juan

    Salamanca, 37005, Spain

  • Centro de Salud Mental La Corredoria

    Oviedo, 33011, Spain

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

    Gdansk, 80-546, Poland

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Clerkenwell Health

    London, W1G 8DR, United Kingdom

  • Department of Pharmacology and Physiology of CNS

    Warsaw, 02-957, Poland

  • Department of Psychiatry, UCK

    Gdansk, 80-214, Poland

  • Department of Psychiatry, University Hospital Frankfurt

    Frankfurt am Main, 60528, Germany

  • Dept. of Psychiatry and School Psychological Sciences, Monash University

    Clayton, Victoria, 3168, Australia

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

    Atlanta, Georgia, 30329, United States

  • Fundación de Investigación HM Hospital

    Madrid, 28050, Spain

  • Hospital Clinic de Barcelona, Psychiatry and Psychology Dept.

    Barcelona, 08036, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Insite clinical research

    DeSoto, Texas, 75115, United States

  • Kadima Neuropsychiatry Institute

    San Diego, California, 92037, United States

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

    London, SE5 8AF, United Kingdom

  • Klinika Inventiva

    Tuszyn, 95-080, Poland

  • NIHR Exeter Clinical Research Facility

    Exeter, EX2 5DW, United Kingdom

  • NeuroCentrix Research

    Melbourne, 3053, Australia

  • New York State Psychiatric Institute

    New York, New York, 10032, United States

  • OVID Clinic, Augmented Psychotherapy

    Berlin, 10247, Germany

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

    Santa Monica, California, 90404, United States

  • Parc Sanitari Sant Joan de Deu HD Numancia

    Barcelona, 08029, Spain

  • Portland Psychotherapy

    Portland, Oregon, 97227, United States

  • Royal Melbourne Hospital, University of Melbourne

    Parkville, 3050, Australia

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050, Australia

  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Lodz, 92-216, Poland

  • San Francisco Insight and Integration Center

    San Francisco, California, 94114, United States

  • Segal Trials Center for Psychedelic and Cannabis Research

    Lauderhill, Florida, 33319, United States

  • Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)

    Rockville, Maryland, 20850, United States

  • UAB School of Public Health, Department of Health Behavior

    Birmingham, Alabama, 35209, United States

  • University of Wisconsin, Dept of Family Medicine & Community Health

    Madison, Wisconsin, 53705, United States

  • Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14

    Tübingen, 72076, Germany

  • Wholeness Center

    Fort Collins, Colorado, 80525, United States

  • Woodland Research Northwest

    Rogers, Arkansas, 72758, United States

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