Using an NMDA enhancer to treat schizophrenia without antipsychotics
Monotherapy of an NMDA Enhancer for Schizophrenia
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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT04745143 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown some success with NMDA enhancers in treating schizophrenia, but this approach as a monotherapy is relatively novel.
Eligibility criteria
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 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.