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BPL-003 for Treatment Resistant Depression
Phase 2
Recruiting
Research Sponsored by Beckley Psytech Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 1 months
Treatment 1 months
Follow Up 1 months
Awards & highlights
Study Summary
This trial tests a new drug + therapy for people with depression that can't be treated with other methods.
Who is the study for?
This trial is for adults with treatment-resistant depression, which means their condition didn't improve after trying at least two different antidepressants. They must have a certain level of depression severity and be willing to stop current antidepressants. People can't join if they're pregnant or not using contraception, have uncontrolled medical conditions like heart issues or diabetes, nasal blockages, severe psychiatric disorders other than depression, recent suicidal behavior, or haven’t responded to similar treatments before.Check my eligibility
What is being tested?
The study tests BPL-003's effectiveness and safety in treating resistant depression when given once alongside psychological support. It’s a Phase 2 trial where participants are randomly assigned and neither they nor the researchers know who receives the actual drug versus a placebo (quadruple masked).See study design
What are the potential side effects?
While specific side effects of BPL-003 aren't listed here, common risks may include typical reactions to new medications such as headaches, nausea, dizziness or more serious ones depending on how it affects brain chemistry.
Timeline
Screening ~ 1 months2 visits
Treatment ~ 1 months5 visits
Follow Up ~ 1 months2 visits
Screening ~ 1 months
Treatment ~ 1 months
Follow Up ~1 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)
Plasma levels of 5-MeO-DMT and its metabolites
Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Medium doseExperimental Treatment1 Intervention
Group II: Low doseExperimental Treatment1 Intervention
Active placebo comparator
Group III: High doseExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BPL-003
2022
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
Beckley Psytech LimitedLead Sponsor
5 Previous Clinical Trials
166 Total Patients Enrolled
VP & Head of Clinical DevelopmentStudy DirectorBeckley Psytech Ltd
Chief Medical Officer, MD, PhDStudy DirectorBeckley Psytech Ltd
3 Previous Clinical Trials
126 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have treatment-resistant depression after trying at least 2 different medications.I am not pregnant, breastfeeding, and if able to bear children, I agree to use contraception during the study.I have been diagnosed with moderate to severe depression.I am a sexually active male not using contraception during the study.I am willing to stop taking my current antidepressants if needed.I don't have nasal problems that could affect taking the study medication.I have a history of severe mental health issues, including schizophrenia or bipolar disorder.A close family member has schizophrenia, bipolar, delusional disorder, or schizoaffective disorder.I have not had a seizure in the last 2 years.I have not had thoughts or actions of suicide in the last year.I have high blood pressure that isn't well-controlled.I have not responded to treatments like ketamine or ECT for my condition.I do not have any uncontrolled conditions like thyroid issues, diabetes, or kidney problems.I am willing to stop taking my current antidepressants.I have treatment-resistant depression after trying at least 2 different medications.Your symptoms are rated as moderate to severe on a scale used for assessment.I have been diagnosed with moderate to severe depression.
Research Study Groups:
This trial has the following groups:- Group 1: High dose
- Group 2: Low dose
- Group 3: Medium dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Months to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who has been cleared to partake in this experiment?
"Individuals aged 18 to 75 who have been diagnosed with major depression may be eligible for enrollment in this medical trial. A total of 225 patients are being sought after."
Answered by AI
Is the Low Dose regimen a safe option for patients?
"Our experts at Power rated Low dose as a 2 on the safety scale given there was only data to support its security yet no evidence of efficacy in Phase 2 trials."
Answered by AI
Is eligibility for this medical research restricted to individuals over eighteen years of age?
"This trial is open to legal adults, aged 18 and above, up until the age of 75."
Answered by AI
Is enrollment still open for the clinical trial?
"As attested by clinicaltrials.gov, this medical study has not been actively recruiting since May 12th 2023. Despite the inactivity of this trial, 1383 other trials are currently seeking participants for their research efforts."
Answered by AI
Who else is applying?
What site did they apply to?
New York State Psychiatric Institute
Other
Segal Trials Center for Psychedelic and Cannabis Research
Sunstone Medical PC (Sunstone Therapies / Aquilino Cancer Center)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I’ve experienced treatment resistant depression for most of my life and wish to join this trial, to hopefully experience longer term relief from depression and would like to be a part of discovering new treatment. I live near Denver and would be able to commute to Fort Collins. I would agree to release my medical information if accepted into the study.
Many thanks,
Jane.
PatientReceived 1 prior treatment
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