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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
If currently taking antidepressant medications, willing and able to discontinue current antidepressants
Be older than 18 years old
Timeline
Screening 1 months
Treatment 1 months
Follow Up 1 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a nasal spray drug called BPL-003 along with counseling for people whose depression doesn't get better with usual treatments. The drug aims to quickly improve mood, and counseling helps provide emotional support.
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.
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).
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
179 Total Patients Enrolled
Chief Medical Officer, MD, PhDStudy DirectorBeckley Psytech Ltd
3 Previous Clinical Trials
139 Total Patients Enrolled
VP & Head of Clinical DevelopmentStudy DirectorBeckley Psytech Ltd
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to stop taking my current antidepressants.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 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.
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