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BPL-003 Efficacy and Safety in Treatment Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05870540
Recruitment Status : Recruiting
First Posted : May 23, 2023
Last Update Posted : April 10, 2024
Sponsor:
Information provided by (Responsible Party):
Beckley Psytech Limited

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
Treatment Resistant Depression Drug: BPL-003 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Quadruple masking: participant, Investigator, therapist, outcomes assessor and Sponsor
Primary Purpose: Treatment
Official Title: A Quadruple Masked, Dose-Finding Study to Evaluate the Efficacy and Safety of Intranasal BPL-003 in Patients With Treatment Resistant Depression
Actual Study Start Date : September 14, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 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 :
  1. Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 week ]
    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.

  2. Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 4 weeks and 1 week ]
    Medium 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.

  3. Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse events [ Time Frame: 8 weeks ]
  4. Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory tests [ Time Frame: 8 weeks ]
  5. Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal vital sign measurements [ Time Frame: 8 weeks ]
  6. Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters compared [ Time Frame: 8 weeks ]
  7. Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior [ Time Frame: 8 weeks ]
  8. Plasma levels of 5-MeO-DMT and its metabolites [ Time Frame: 1 day ]


Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. At least moderate major depressive disorder.
  2. 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.
  3. Hamilton Depression Rating Scale score ≥19 at Screening and Baseline.
  4. CGI-S ≥4 at Screening and Baseline.
  5. If currently taking antidepressant medications, willing and able to discontinue current antidepressants.

Exclusion Criteria:

  1. Current or past history of schizophrenia, psychotic disorder including psychotic depression, bipolar disorder, delusional disorder, schizoaffective disorder, or any other severe psychiatric disorder.
  2. Current personality disorders.
  3. First-degree family history of schizophrenia, bipolar disorder, delusional disorder, or schizoaffective disorder.
  4. Current alcohol or substance use disorder (other than caffeine or nicotine).
  5. 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.
  6. Suicidal ideation or behavior within the 12 months prior to the start of Screening or on Day 1 prior to dosing.
  7. Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening.
  8. Uncontrolled medical conditions e.g. hypo/hyperthyroidism, diabetes, renal failure.
  9. History or current uncontrolled hypertension.
  10. Seizure disorder or any seizure in the 2 years prior to Screening.
  11. Has clinically significant results on ECG during the Screening.
  12. 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.
  13. Female participants who are pregnant, lactating, or of childbearing potential and not willing to use adequate forms of contraception during the study.
  14. Male participants who are sexually active and not willing to use adequate forms of contraception during the study.

Information from the National Library of Medicine

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): NCT05870540


Contacts
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Contact: Beckley Psytech Ltd +44 (0)1865 987633 Medinfo@beckleypsytech.com

Locations
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Sponsors and Collaborators
Beckley Psytech Limited
Investigators
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Study Director: VP & Head of Clinical Development Beckley Psytech Ltd
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Responsible Party: Beckley Psytech Limited
ClinicalTrials.gov Identifier: NCT05870540    
Other Study ID Numbers: BPL-003-201
First Posted: May 23, 2023    Key Record Dates
Last Update Posted: April 10, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders