BPL-003 Efficacy and Safety in Treatment Resistant Depression

Completed · Phase 2

Conditions studied: Treatment Resistant Depression

In brief

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).

Key facts

Study ID

NCT05870540

Run by

Beckley Psytech Limited

People needed

196

Starts

2023-09-14

Expected to finish

2025-07-03

Last updated by the study team

2025-07-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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