NCT07575516 Risperidone Schizophrenia Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07575516 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: 13 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07575516 is a hot trial to watch
Schizophrenia is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07575516 is notable because it evaluates Risperidone in a Phase 2 design sponsored by Universitas Hasanuddin. 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 | NCT07575516 |
| Official title | Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone (WSE-SCZ) |
| Phase / status | Phase 2 / Completed |
| Intervention | Risperidone |
| Sponsor | Universitas Hasanuddin |
| Geography | Indonesia |
| Enrollment | [object Object] |
| Primary endpoint | Change in serum Interleukin-1beta levels |
| Endpoint time frame | Baseline to week 8 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This study aims to evaluate the effectiveness of Ashwagandha (Withania somnifera) extract as an adjuvant therapy in patients with schizophrenia who are receiving risperidone. Schizophrenia is a chronic mental disorder associated with neuroinflammation and immune dysregulation, including increased levels of pro-inflammatory cytokines such as interleukin-1 beta (IL-1β). In this study, patients diagnosed with schizophrenia are given standard treatment with risperidone, with or without additional Ashwagandha extract. The primary outcomes are changes in Interleukin-1β levels and clinical symptoms assessed using the Positive and Negative Syndrome Scale (PANSS). The study aims to determine whether Ashwagandha extract supplementation can reduce inflammation and improve clinical symptoms in patients with schizophrenia. The findings support the use of Ashwagandha extract as a complementary therapy to enhance treatment outcomes in schizophrenia.
Allocation is Randomized, masking is Triple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Indonesia 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.
- Change in serum Interleukin-1beta levels (Baseline to week 8) — The primary outcome is the change in serum Interleukin-1beta levels measured to evaluate the anti-inflammatory effect of the intervention
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: Risperidone 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: Universitas Hasanuddin is resolved to a normalized organization record in Indonesia. 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
NCT07575516 provides a focused lens on Schizophrenia development. Its value will be determined by whether Risperidone can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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