NCT07412132 Lacosamide Bipolar Disorder Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07412132 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 24 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07412132 is a hot trial to watch
Bipolar Disorder is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07412132 is notable because it evaluates Lacosamide in a Phase 3 design sponsored by University of Sao Paulo. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07412132 |
| Official title | Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II. |
| Phase / status | Phase 3 / Recruiting |
| Intervention | Lacosamide |
| Sponsor | University of Sao Paulo |
| Geography | Brazil |
| Enrollment | [object Object] |
| Primary endpoint | Primary outcome |
| Endpoint time frame | week 12 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving depressive and manic symptoms in individuals with bipolar disorder (BD). The primary objective of this study is to evaluate the efficacy of combining lacosamide as an augmentation treatment to first- or second-line medication treatments in moderate to severe major depressive episodes of treatment-resistant BD I and II (failure of at least two adequate treatments during the current episode). The main hypothesis of the study is that lacosamide produces a greater reduction in depression scores compared to a placebo treatment and that both groups will exhibit similar rates of side effects and adverse events. We will conduct a double-blind, randomized, parallel-group pilot study, comparing the enhancement of the treatment
Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Brazil shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Primary outcome (week 12) — The efficacy of lacosamide assessed by the difference in Hamilton Depression Scale score from the initial visit to the end of week 12 of the intervention between the lacosamide and placebo groups. Minimum: 0 point Maximum: 50 points. The increase in the pontuation of the scale is related to worse outcomes.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Lacosamide is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: University of Sao Paulo is resolved to a normalized organization record in Brazil. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07412132 provides a focused lens on Bipolar Disorder development. Its value will be determined by whether Lacosamide can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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