Clinical TrialTreatment-Resistant Depression (TRD)Completed

BPL-003 Efficacy and Safety in Treatment Resistant Depression

This quadruple-masked, randomised, multi-centre Phase II study (n=225) investigates the efficacy and safety of a single intranasal dose of BPL-003, combined with psychological support, in patients with treatment-resistant depression (TRD).

Target Enrollment
196 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-masked multi-centre Phase II study in treatment‑resistant depression assessing single intranasal doses of BPL‑003 (low/medium/high) with psychological support and 8‑week follow-up.

Approximately 196 participants are recorded as actual enrolment in the registry fragment; participants receive one dose and may receive a second monophasic or biphasic intranasal dose in an open‑label extension, with further 8‑week follow-up.

Psychological support is provided before, during and after dosing; outcomes include depression severity (HDRS), CGI-S and safety assessments including ECG and medical monitoring.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Low dose

experimental

Single intranasal low dose of BPL-003 (active placebo comparator).

Interventions

  • Compound
    via Intranasal• single dose• 1 doses total

    BPL-003 low dose (exact dose not specified in source).

Medium dose

experimental

Single intranasal medium dose of BPL-003.

Interventions

  • Compound
    via Intranasal• single dose• 1 doses total

    BPL-003 medium dose (exact dose not specified in source).

High dose

experimental

Single intranasal high dose of BPL-003.

Interventions

  • Compound
    via Intranasal• single dose• 1 doses total

    BPL-003 high dose (exact dose not specified in source).

Monophasic

experimental

Single monophasic intranasal BPL-003 (possible second-dose OLE).

Interventions

  • Compound
    via Intranasal• single dose• 1 doses total

    Monophasic BPL-003 formulation; second dose may be given in OLE.

Biphasic

experimental

Biphasic intranasal BPL-003 administered as two sprays minutes apart.

Interventions

  • Compound
    via Intranasal• single dose• 1 doses total

    Biphasic: two nasal sprays minutes apart; used in OLE/second-dose schedule.

Participants

Ages
18 – 75
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. At least moderate major depressive disorder.
  • 2. 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.
  • 3. Hamilton Depression Rating Scale score ≥19 at Screening and Baseline.
  • 4. CGI-S ≥4 at Screening and Baseline.
  • 5. If currently taking antidepressant medications, willing and able to discontinue current antidepressants.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Current or past history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
  • 2. Current personality disorders.
  • 3. First-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder.
  • 4. Current alcohol or substance use disorder (other than caffeine or nicotine).
  • 5. 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.
  • 6. Suicidal ideation or behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
  • 7. Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.
  • 8. Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
  • 9. History or current uncontrolled hypertension.
  • 10. Seizure disorder or any seizure in the 2 years prior to Screening.
  • 11. Has clinically significant results on ECG during the Screening.
  • 12. 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.
  • 13. Female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study.
  • 14. Male participants who are sexually active and not willing to use adequate forms of contraception during the study.

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment196 participants
  • Timeline
    Start: 2023-09-14
    End: 2024-12-31
  • Topic
    Treatment-Resistant Depression (TRD)

Locations

UAB School of Public Health, Department of Health Behavior — Birmingham, Alabama, United States
Woodland Research Northwest — Rogers, Arkansas, United States
Kadima Neuropsychiatry Institute — San Diego, California, United States
San Francisco Insight and Integration Center — San Francisco, California, United States
Pacific Neuroscience Institute, Treatment and Research in Psychedelics (TRIP) Program — Santa Monica, California, United States
Wholeness Center — Fort Collins, Colorado, United States
Segal Trials Center for Psychedelic and Cannabis Research — Lauderhill, Florida, United States
Emory University, Brain Health Center, Department of Psychiatry and Behavioral Sciences — Atlanta, Georgia, United States
CenExel ACMR — Atlanta, Georgia, United States
CenExel iResearch — Decatur, Georgia, United States
Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center) — Rockville, Maryland, United States
Boston Clinical Trials — Boston, Massachusetts, United States
CenExel HRI — Berlin, New Jersey, United States
New York State Psychiatric Institute — New York, New York, United States
Portland Psychotherapy — Portland, Oregon, United States
Insite clinical research — DeSoto, Texas, United States
AIM Trials — Plano, Texas, United States
Cedar Clinical Research — Draper, Utah, United States
University of Wisconsin, Dept of Family Medicine & Community Health — Madison, Wisconsin, United States
Royal Prince Alfred Hospital — Sydney, New South Wales, Australia
Dept. of Psychiatry and School Psychological Sciences, Monash University — Clayton, Victoria, Australia
NeuroCentrix Research — Melbourne, Australia
Royal Melbourne Hospital, University of Melbourne — Parkville, Australia
Charité - Universitätsmedizin Berlin — Berlin, Germany
OVID Clinic, Augmented Psychotherapy — Berlin, Germany
Department of Psychiatry, University Hospital Frankfurt — Frankfurt am Main, Germany
Central Institute of Mental Health, Dept. of Molecular Neuroimaging — Mannheim, Germany
Universitätsklinik für Psychiatrie und Psychotherapie, Calwerstr. 14 — Tübingen, Germany
Department of Psychiatry, UCK — Gdansk, Poland
Centrum Badań Klinicznych PI-House sp. z o.o. — Gdansk, Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi — Lodz, Poland
Klinika Inventiva — Tuszyn, Poland
Department of Pharmacology and Physiology of CNS — Warsaw, Poland
Hospital del Mar — Barcelona, Spain
Parc Sanitari Sant Joan de Deu HD Numancia — Barcelona, Spain
Hospital Clinic de Barcelona, Psychiatry and Psychology Dept. — Barcelona, Spain
Fundación de Investigación HM Hospital — Madrid, Spain
Centro de Salud Mental La Corredoria — Oviedo, Spain
Centro Salud San Juan — Salamanca, Spain
NIHR Exeter Clinical Research Facility — Exeter, United Kingdom
King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD) — London, United Kingdom
Clerkenwell Health — London, United Kingdom

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