BPL-003 for Treatment Resistant Depression

No longer recruiting at 46 trial locations

Overseen By Beckley Psytech Ltd

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Beckley Psytech Limited

Must not be taking: Antidepressants

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called BPL-003, a potential drug for treatment-resistant depression, where typical medications prove ineffective. Researchers compare different doses and methods of using BPL-003, alongside psychological support, to determine the most effective approach. Ideal participants have experienced moderate to severe depression despite trying at least two different medications. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

If you are currently taking antidepressant medications, you must be willing and able to stop taking them to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BPL-003 is generally safe for people. Studies found that most participants did not experience serious side effects, indicating it was well-tolerated. When side effects occurred, they were mild to moderate, causing only minor discomfort. Notably, BPL-003 was tested with just one dose and quickly produced lasting antidepressant effects. For those considering joining a trial, this offers promising news about the treatment's safety and potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for treatment-resistant depression, like SSRIs or SNRIs, work by altering serotonin or norepinephrine levels in the brain. But BPL-003 is different because it uses a novel approach with potential psychedelic effects to tackle depression. Researchers are excited about BPL-003 because it may offer faster and more profound relief than traditional options. Additionally, BPL-003 is being tested in various formulations, including monophasic and biphasic, as well as different doses, which might cater to individual patient needs and optimize treatment outcomes.

What evidence suggests that this trial's treatments could be effective for treatment resistant depression?

Research has shown that BPL-003 could benefit people with treatment-resistant depression. Studies found that a single dose of BPL-003 can quickly and lastingly reduce depression symptoms. Specifically, 55% of patients experienced a complete disappearance of their symptoms soon after taking it. A second dose two weeks later can enhance these positive effects. This trial will explore different dosing regimens, including monophasic and biphasic approaches, as well as varying doses, to determine the most effective strategy for providing significant relief for those who haven't found success with other treatments. ^{1 3 5 6 7}

Who Is on the Research Team?

VP & Head of Clinical Development

Principal Investigator

Beckley Psytech Ltd

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

If currently taking antidepressant medications, willing and able to discontinue current antidepressants

I have treatment-resistant depression after trying at least 2 different medications.

I have been diagnosed with moderate to severe depression.

Exclusion Criteria

Suicide attempt and/or self-injurious behavior within the last 12 months prior to Screening

Has clinically significant results on ECG during the Screening

Current personality disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intranasal dose of BPL-003 with psychological support

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• BPL-003

Trial Overview 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).

How Is the Trial Designed?

Group I: Monophasic Experimental Treatment 1 Intervention

Group II: Medium dose Experimental Treatment 1 Intervention

Group III: Low dose Experimental Treatment 1 Intervention

Active placebo comparator

Group IV: High dose Experimental Treatment 1 Intervention

Group V: Biphasic Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Beckley Psytech Limited

Lead Sponsor

Trials

7

Recruited

490+

Citations

1. psychiatrictimes.com psychiatrictimes.com/view/bpl-003-for-treatment-resistant-depression-new-positive-phase-2a-data

BPL-003 for Treatment-Resistant Depression: New Positive ... Investigators found that BPL-003 demonstrated rapid, robust, and durable antidepressant effects with just a single 8 mg or 12 mg dose. 2. “This ...

2. beckleypsytech.com beckleypsytech.com/posts/atai-life-sciences-and-beckley-psytech-report-positive-phase-2a-data-with-two-dose-induction-regimen-of-bpl-003-in-patients-with-treatment-resistant-depression

atai Life Sciences and Beckley Psytech Report Positive ... The results demonstrate that a second dose of BPL-003 at Week 2 has the potential to induce greater antidepressant effects, as evidenced by ...

3. beckleypsytech.com beckleypsytech.com/posts/beckley-psytech-to-present-data-on-bpl-003-intranasal-mebufotenin-benzoate-and-anhedonia-at-ecnp-2025

Beckley Psytech to present data on BPL-003 (intranasal ... 55% of patients met the criteria for remission from depression the day after dosing and this antidepressant effect was durable, with 55% of ...

4. ddw-online.com ddw-online.com/positive-data-published-on-bpl-003-for-patients-with-trd-37175-202509/

Positive data published on BPL-003 for patients with TRD The results demonstrate that a second dose of BPL-003 at week two has the potential to induce greater antidepressant effects, as evidenced by ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05870540

NCT05870540 | BPL-003 Efficacy and Safety in Treatment ... A higher MADRS score indicates more severe depression, and each item yields a score of 0-6. 4 weeks. OLE Primary Safety Outcome Measure, To determine the safety ...

6. beckleypsytech.com beckleypsytech.com/posts/positive-data-from-phase-2a-study-of-bpl-003-with-ssris-for-treatment-resistant-depression

Beckley Psytech announces positive topline data from Part ... Data from that study showed that a single dose of BPL-003 was well-tolerated and produced a rapid and lasting antidepressant effect for up to ...

7. beckleypsytech.com beckleypsytech.com/posts/beckley-psytech-completes-enrolment-in-phase-iib-study-of-bpl-003-for-treatment-resistant-depression

Beckley Psytech Completes Enrolment in Phase IIb study ... The study is evaluating the efficacy and safety of a single medium or high dose of BPL-003 against a sub-perceptual dose, with patients followed ...