Using an NMDA enhancer to treat schizophrenia without antipsychotics
Official title: Monotherapy of an NMDA Enhancer for Schizophrenia
Run by China Medical University Hospital · NCT04745143 · Data updated 2026-11-12
This study is testing if a new medication can help people with schizophrenia who can't or don't want to take antipsychotics feel better and improve their thinking skills.
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 | January 1, 2018 |
| Main results expected | September 2027 |
| Study ends | December 2027 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT04745143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with schizophrenia who refuse or are unable to tolerate antipsychotics due to poor response or severe side effects.
✕Probably not a fit
Patients with current substance abuse issues, serious medical conditions, or those who have used depot antipsychotics recently 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 efficacy and safety of an NMDA enhancer (NMDAE) as a monotherapy for schizophrenia in patients who refuse or cannot tolerate antipsychotics. It is a 6-week randomized, double-blind trial where participants will receive either NMDAE or a placebo. Clinical performance and side effects will be measured biweekly, while cognitive functions will be assessed at the beginning and end of the treatment. The goal is to determine if NMDAE can effectively reduce symptoms and cognitive deficits associated with schizophrenia.
Why it matters
Potential benefit: If successful, this treatment could provide an alternative for patients with schizophrenia who cannot tolerate traditional antipsychotics.
How similar studies have gone: Previous studies have shown some success with NMDA enhancers in treating schizophrenia, but this approach as a monotherapy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia * Refuse or are unable to tolerate antipsychotics due to poor response or adverse effects * PANSS total score ≥ 60 * Free of antipsychotic drugs for at least 1 week * Agree to participate in the study and provide informed consent Exclusion Criteria: * Current substance abuse or history of substance dependence in the past 3 months * History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study * Use of depot antipsychotic in the past 3 months; * Clinically significant laboratory screening 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.