Combining NMDA-enhancing and anti-inflammatory treatments for schizophrenia
Combination of NMDA-enhancing and Anti-inflammatory Treatments for Schizophrenia
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT04917302 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with schizophrenia who have not responded adequately to at least two different antipsychotic medications.
Not a fit: Patients with intellectual disabilities, substance use disorders, or other serious medical conditions may not benefit from this study.
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 performed: While previous studies have explored NMDA-enhancing agents and anti-inflammatory treatments separately, this combined approach is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Taichung
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.