BPL-003 Efficacy and Safety in Treatment Resistant Depression
- Registration Number
- NCT05870540
- Lead Sponsor
- Beckley Psytech Limited
- Brief Summary
This is a Phase 2 study randomized, quadruple masked, multi-center study , with a Open Label Extension, designed to investigate the efficacy and safety of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).
- Detailed Description
Approximately 200 eligible participants will receive a single dose of either low, medium, or high doses of BPL-003, given intranasally, with 8 weeks of follow up assessments. Following this participants may receive a second dose of either monophasic or biphasic dose of BPL-003, given intranasally, with another 8 weeks of follow up assessments.
Psychological support will be given before, during and after each dosing.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 196
- At least moderate major depressive disorder.
- 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.
- Hamilton Depression Rating Scale score ≥19 at Screening and Baseline.
- CGI-S ≥4 at Screening and Baseline.
- If currently taking antidepressant medications, willing and able to discontinue current antidepressants.
- Current or past history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
- Current personality disorders.
- First-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder.
- Current alcohol or substance use disorder (other than caffeine or nicotine).
- 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.
- Suicidal ideation or behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
- Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.
- Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
- History or current uncontrolled hypertension.
- Seizure disorder or any seizure in the 2 years prior to Screening.
- Has clinically significant results on ECG during the Screening.
- 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.
- Female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study.
- Male participants who are sexually active and not willing to use adequate forms of contraception during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose BPL-003 Active placebo comparator Medium dose BPL-003 - High dose BPL-003 - Monophasic BPL-003 - Biphasic BPL-003 -
- Primary Outcome Measures
Name Time Method Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) 4 weeks High compared to low dose of BPL-003. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0-6.
OLE Primary Safety Outcome Measure 8 weeks To determine the safety of a second dose of BPL-003 given with psychological support to participants with TRD as assessed by treatment-emergent adverse events.
- Secondary Outcome Measures
Name Time Method Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory tests 8 weeks Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior 8 weeks Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse events 8 weeks Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters compared 8 weeks Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) 4 weeks and 1 week Medium compared to low dose of BPL-003. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0-6.
Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurements 8 weeks Plasma levels of 5-MeO-DMT and its metabolites 1 day
Trial Locations
- Locations (42)
Hospital del Mar
🇪🇸Barcelona, Spain
Centro Salud San Juan
🇪🇸Salamanca, 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
Department of Pharmacology and Physiology of CNS
🇵🇱Warsaw, Poland
Wholeness Center
🇺🇸Fort Collins, Colorado, United States
Segal Trials Center for Psychedelic and Cannabis Research
🇺🇸Lauderhill, Florida, United States
NIHR Exeter Clinical Research Facility
🇬🇧Exeter, United Kingdom
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
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
🇩🇪Tubingen, 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
King's College London - Institute of Psychiatry, Psychology & Neuroscience (IoPPN) - Centre for Affective Disorders (CfAD)
🇬🇧London, United Kingdom
Clerkenwell Health
🇬🇧London, United Kingdom