Combining NMDA-enhancing and anti-inflammatory treatments for difficult-to-treat schizophrenia
Official title: Combination of NMDA-enhancing and Anti-inflammatory Treatments for Ultra-resistant Schizophrenia
Run by China Medical University Hospital · NCT05240976 · Data updated 2026-11-12
This study is testing if a new combination of medications can help people with tough-to-treat schizophrenia feel better when other treatments haven't worked.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Status | Recruiting |
| Started | February 23, 2022 |
| Main results expected | February 2027 |
| Study ends | March 2027 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT05240976 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with schizophrenia who have shown resistance to at least two antipsychotic treatments prior to clozapine and have not achieved satisfactory results after 12 weeks of clozapine therapy.
✕Probably not a fit
Patients with intellectual disabilities, substance use disorders, or other serious medical conditions that could interfere with the study may not benefit from this trial.
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 patients with ultra-resistant schizophrenia who have not responded adequately to clozapine. Participants will be randomly assigned to receive either the NMDA-enhancer with the anti-inflammatory agent or a placebo for a duration of 12 weeks. The study will assess cognitive functions and clinical performance at various intervals to determine the efficacy of the treatment combinations. The goal is to explore whether the anti-inflammatory drug can enhance the effects of the NMDA-enhancer in improving symptoms of schizophrenia.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with ultra-resistant schizophrenia, potentially improving their clinical symptoms and cognitive function.
How similar studies have gone: While previous studies have explored NMDA-enhancing agents and anti-inflammatory treatments separately, this specific combination 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 treatment-resistant to standard treatments of at least two specific antipsychotics before clozapine treatment * Are receiving adequate trials of clozapine for more than 12 weeks but without satisfactory response * PANSS total score ≥ 70; SANS total score ≥ 40 * Have sufficient education to communicate effectively and are capable of completing the assessments of the study * 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, 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.