Combining NMDA-enhancing and anti-inflammatory treatments for schizophrenia
Official title: Combination of NMDA-enhancing and Anti-inflammatory Treatments for Schizophrenia
Run by China Medical University Hospital · NCT04917302 · Data updated 2026-11-12
This study is testing if a new combination of treatments can help people with treatment-resistant schizophrenia feel better compared to a placebo while they continue their usual medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Status | Recruiting |
| Started | October 13, 2020 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT04917302 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults diagnosed with schizophrenia who have not responded adequately to at least two different antipsychotic medications.
✕Probably not a fit
Patients with intellectual disabilities, substance use disorders, or other serious medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of combining an NMDA-enhancing agent with an anti-inflammatory drug in treating patients with treatment-resistant schizophrenia. Participants will be randomly assigned to receive either the combination treatment or a placebo while maintaining their current antipsychotic regimen. The study will last for 12 weeks, during which clinical performance and cognitive functions will be assessed at multiple time points. The goal is to determine if the combined treatment offers superior benefits compared to the NMDA-enhancer alone.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with treatment-resistant schizophrenia.
How similar studies have gone: While previous studies have explored NMDA-enhancing agents and anti-inflammatory treatments separately, this combined approach is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia * Are resistant to adequate treatments of at least two antipsychotics * Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial * PANSS total score ≥ 70 * Agree to participate in the study and provide informed consent Exclusion Criteria: * DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder * History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study * Clinically significant laboratory screening tests (including blood routine, biochemical tests) * Pregnancy or lactation * Inability to follow protocol
Where it's running
-
Department of Psychiatry, China Medical University Hospital
Taichung, Taiwan Recruiting
Study contacts
- Study coordinator: Hsien-Yuan Lane, M.D., Ph.D
- Email: hylane@gmail.com
- Phone: 886 4 22052121
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.