An Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression
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|ClinicalTrials.gov Identifier: NCT05660642|
Recruitment Status : Recruiting
First Posted : December 21, 2022
Last Update Posted : March 30, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Depression||Drug: BPL-003||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Phase 2a, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BPL-003 in Patients With Treatment Resistant Depression|
|Actual Study Start Date :||February 10, 2023|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2023|
|Experimental: BPL-003 arm||
Single dose administered intranasally
- To assess the safety and tolerability of a single intranasal dose of BPL-003 in patients with treatment resistant depression [ Time Frame: Baseline to 12 weeks post dose ]
- Percentage of patients with treatment emergent adverse events
- Percentage of patients with clinically significant abnormal laboratory tests
- Percentage of patients with clinically significant abnormal vital signs
- Percentage of patients with clinically significant findings in physical examination
- Percentage of patients with clinically significant ECG parameters
- Percentage of patients with suicidal ideation or behavior
- Change from Baseline in MADRS [ Time Frame: Day 2 to 12 weeks post dose ]
- Percentage of responders [ Time Frame: Day 2 to 12 weeks post dose ]Defined as 50% reduction in MADRS score compared to Baseline
- Percentage of patients in remission [ Time Frame: Day 2 to 12 weeks post dose ]Defined as MADRS score of <11
- Plasma levels of 5-MeO-DMT and its metabolite (bufotenine) [ Time Frame: Day 1 ]
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Diagnosed with Major Depressive Disorder.
- Diagnosed with TRD defined as failure to respond to an adequate dose and duration of at least 2 pharmacological treatments.
- Montgomery-Asberg Depression Rating Scale score ≥24 at Screening.
- Clinical Global Impression - Severity ≥4 at Screening.
- Quick Inventory of Depressive Symptomatology - Self Rated - 16 item scale ≥13 at Screening.
- Willing and able to discontinue current pharmacological anti-depressant therapy.
- Current or 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, personality disorders 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.
- Seizure disorder or history of seizures (including febrile seizures).
- Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram, or laboratory tests at Screening Baseline.
- Any nasal obstruction, blockage, or symptoms of congestion at the time of dosing, that in the Investigator's opinion may interfere with administration of the study drug.
- Currently receiving lithium, antipsychotics, serotonergic drugs, psychostimulants, or any other prohibited medication.
- Female patients who are pregnant or lactating, or of childbearing potential and not willing to use adequate forms of contraception.
- Male patients who are sexually active and not willing to using adequate forms of contraception.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05660642
|Contact: Beckley Psytech Ltd||+44 (0)1865 987633||Medinfo@beckleypsytech.com|
|Hammersmith Medicines Research||Recruiting|
|London, United Kingdom|
|Contact: Study Coordinator +44 (0)20 8961 4130 REC@hmrlondon.com|
|King's College London, Clinical Trials Facility||Recruiting|
|London, United Kingdom|
|Contact: Clinical Trials Facility email@example.com|
|Study Director:||Chief Medical Officer, MD, PhD||Beckley Psytech Ltd|
|Responsible Party:||Beckley Psytech Limited|
|Other Study ID Numbers:||
|First Posted:||December 21, 2022 Key Record Dates|
|Last Update Posted:||March 30, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Depressive Disorder, Treatment-Resistant