Treatment Resistant Depression / BPL-003 · Phase 2 Trial

BPL-003 Efficacy and Safety in Treatment Resistant Depression

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2, randomized, quadruple-masked, multicenter clinical trial evaluating BPL-003 (a novel drug) in treatment-resistant depression. The study has completed enrollment of 196 participants and includes a primary efficacy endpoint (MADRS score change at day 29) and safety endpoints; however, results are not reported in this registry record.

What was studied

Phase 2, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Treatment Resistant Depression; age from 18 Years; to 75 Years. Intervention: Low dose (sub-therapeutic); Medium dose; High dose; Monophasic; Biphasic. Compared with: BPL-003 0.3 mg. n = 196. 42 sites across 6 countries.

Key findings

Safety

This is a registry record only; no efficacy or safety results are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 2 trial with planned enrollment of 196 participants studying a novel psychiatric drug; results not yet reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Core: Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Day 29 (12 mg vs 0.3 mg BPL-003) (assessed at 4 weeks); OLE: Number of Participants With Treatment-emergent Adverse Events in the OLE (assessed at 8 weeks)

DesignPhase 2, Interventional, Randomized, Parallel, Triple masking, Treatment purpose

PopulationTreatment Resistant Depression; age from 18 Years; to 75 Years

Sample size196

InterventionLow dose (sub-therapeutic); Medium dose; High dose; Monophasic; Biphasic

ComparatorBPL-003 0.3 mg

Setting42 sites across 6 countries

Reported figures

Quoted from the source exactly as published.

Sample size196

PhasePhase 2

Primary efficacy endpointChange from baseline in MADRS total score at day 29 (12 mg vs 0.3 mg BPL-003)

Primary safety endpointNumber of participants with treatment-emergent adverse events in OLE at 8 weeks

Study duration (core phase)4 weeks

Study duration (OLE)8 weeks

Caveats

This is a registry record only; no efficacy or safety results are reported.
Comparator arm dose (0.3 mg) and active arm dose (12 mg) are specified but clinical relevance unknown without results.
Open-label extension data will not be blinded and are subject to bias.
No power calculation, statistical plan, or secondary endpoints detailed in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized, quadruple-masked, multicenter Phase 2 trial with OLE arm.

Directness

strong

Evaluates BPL-003 directly in treatment-resistant depression population.

Consistency

insufficient

Single trial; no comparative data from other studies provided.

Risk of bias

moderate

Quadruple-masked design supports low bias; no outcome data available to assess.

Sample adequacy

moderate

196 enrolled in Phase 2; adequate for early efficacy but not definitive.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05870540). This is a study registration, not published results. Lead sponsor: Beckley Psytech Limited. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 196 participants (ACTUAL). Conditions: Treatment Resistant Depression. Interventions: DRUG: BPL-003; DRUG: BPL-003. Primary outcome measures: Core: Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score at Day 29 (12 mg vs 0.3 mg BPL-003) , 4 weeks; OLE: Number of Participants With Treatment-emergent Adverse Events in the OLE , 8 weeks. Brief summary: This is a Phase 2 study randomized, quadruple-masked, multi-center trial with an open-label extension (OLE), designed to investigate the efficacy and safety of BPL-003 in patients with treatment resistant depression (TRD).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Treatment Resistant DepressionBPL-003Beckley PsytechNCT05870540