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 : May 6, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Treatment Resistant Depression | Drug: BPL-003 | Phase 2 |
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 |
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 |
- 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.
- 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.
- 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.
- Safety of BPL-003 given with psychological support as assessed by number and percentage of participants with adverse events [ Time Frame: 8 weeks ]
- Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant abnormal laboratory tests [ Time Frame: 8 weeks ]
- 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 ]
- Safety of BPL-003 given with psychological support as assessed by percentage of participants with clinically significant ECG parameters compared [ Time Frame: 8 weeks ]
- Safety of BPL-003 given with psychological support as assessed by incidence of suicidal ideation or behavior [ Time Frame: 8 weeks ]
- Plasma levels of 5-MeO-DMT and its metabolites [ Time Frame: 1 day ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- CGI-S ≥4 at Screening and Baseline.
- 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.
- Current personality disorders.
- First-degree family history of schizophrenia, bipolar disorder, delusional disorder, 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.
- History or current uncontrolled hypertension.
- Seizure disorder or any seizure in the 2 years prior to Screening.
- Has clinically significant results on ECG during the Screening.
- 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.
- 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.
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
Contact: Beckley Psytech Ltd | +44 (0)1865 987633 | Medinfo@beckleypsytech.com |
Study Director: | VP & Head of Clinical Development | Beckley Psytech Ltd |
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: | May 6, 2024 |
Last Verified: | May 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Depression Depressive Disorder Depressive Disorder, Treatment-Resistant |
Behavioral Symptoms Mood Disorders Mental Disorders |