BPL-003 Efficacy and Safety in Treatment Resistant Depression
Study Details
Study Description
Brief Summary
This is a Phase 2 study randomized, quadruple masked, multi-center study designed to investigate the efficacy and safety of a single dose of BPL-003 combined with psychological support in patients with treatment resistant depression (TRD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Approximately 225 eligible participants will be receive a single dose of either low, medium, or high doses BPL-003, given intranasally, with 8 weeks of follow-up assessments.
Psychological support will be given before, during and after dosing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low dose Active placebo comparator |
Drug: BPL-003
A single dose administered intranasally
|
| Experimental: Medium dose
|
Drug: BPL-003
A single dose administered intranasally
|
| Experimental: High dose
|
Drug: BPL-003
A single dose administered intranasally
|
Outcome Measures
Primary Outcome Measures
- 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.
Secondary Outcome Measures
- Change from baseline in MADRS [1 week]
High compared to low dose of BPL-003
- Change from baseline in MADRS [4 weeks and 1 week]
Medium compared to low dose of BPL-003
- 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 abnormal laboratory tests [8 weeks]
- Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurements [8 weeks]
- Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters compared [8 weeks]
- Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior [8 weeks]
- Plasma levels of 5-MeO-DMT and its metabolites [1 day]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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CGI-S ≥4 at Screening and Baseline.
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QIDS-SR-16 ≥13 at baseline.
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If currently taking antidepressant medications, willing and able to discontinue current antidepressants.
Exclusion Criteria:
-
Current or past history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
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Current personality disorders.
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First-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder.
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Current alcohol or substance use disorder (other than caffeine or nicotine).
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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.
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Suicidal ideation or behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
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Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.
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Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
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History or current uncontrolled hypertension.
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Seizure disorder or any seizure in the 2 years prior to Screening.
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Has clinically significant results on ECG during the Screening.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York State Psychiatric Institute | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Beckley Psytech Limited
Investigators
- Study Director: Chief Medical Officer, MD, PhD, Beckley Psytech Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BPL-003-201