Safety and tolerability study for BPL-003 in hard-to-treat depression
Part of Mental health clinical trials.
This Phase 2 study tests BPL-003 in people with treatment-resistant depression to learn about its safety and how it affects the body and brain. Because it is open-label, everyone knows they are getting the study treatment, and you’ll also need to stop your current antidepressant during the study.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have a diagnosis of major depressive disorder (major depression).
- Your depression has not improved with at least 2 antidepressant medicines at good doses and durations, and at least one was tried during this current episode.
- Your depression scores at screening are high (MADRS score 24 or higher) and your doctor rates your depression as severe (CGI-Severity 4 or higher).
- You can stop your current antidepressant, and you are currently taking only one of these SSRIs: citalopram, escitalopram, sertraline, or fluoxetine at a stable dose.
- You do not have certain mental health conditions like bipolar disorder or psychosis, and you also don’t have a history that strongly suggests them in close family.
- You cannot have certain safety risks—like recent serious suicidal behavior, alcohol/drug use disorder, uncontrolled medical problems, or a seizure history.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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