Testing an NMDA Enhancer for Early Symptoms of Schizophrenia
Early Intervention of Prodromal Schizophrenia Using an NMDA Enhancer
This study is testing if a new medication can help people with early symptoms of schizophrenia feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 13 Years to 45 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT05052853 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an NMDA-enhancing agent in treating individuals with prodromal schizophrenia, a stage characterized by early symptoms. Participants will first undergo a 6-week health-promotion intervention, and those who do not show sufficient improvement will be enrolled in a 12-week randomized, double-blind, placebo-controlled trial. The trial will compare the clinical responses and side effects of the NMDA enhancer against a placebo, with assessments conducted at multiple time points throughout the study. Cognitive functions will also be evaluated to determine the impact of the treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals showing early signs of schizophrenia who meet specific prodromal criteria and remain symptomatic after an initial health-promotion phase.
Not a fit: Patients who do not meet the criteria for prodromal schizophrenia or those who are currently on antipsychotic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals at risk of developing schizophrenia.
How similar studies have performed: Previous studies have shown that NMDA-enhancing agents can improve symptoms in schizophrenia, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals meeting Criteria of Prodromal Syndrome (at least one of the following: 1. attenuated positive symptoms; 2. brief intermittent psychotic symptoms; 3. genetic risk and deterioration). * Subjects remain symptomatic (scoring at least 20 on the Scale of Prodromal Symptoms \[SOPS\] total score) after the 6-week screening phase (which contains the health-promotion program) and before the 12-week drug-trial period. * Subjects may be receiving ongoing treatment with antipsychotic medications, or may be medication-free for at least 12 weeks.For the subjects who have already been on such medications, the medications need to be continued for at least 4 weeks before the screening phase and the doses need to be kept unchanged during the study period. For those who have not yet been on such medications, these medications are forbidden during the study period. * Subjects agree to participate in the study and provide written informed consent after complete description of the study. For the subject \< 20 years old, a parent also has to provide written informed consent. Exclusion Criteria: * DSM-5 diagnosis of intellectual disability, substance (including alcohol) use disorder, schizophrenia, schizophreniform disorder, delusional disorder, schizoaffective disorder, substance/medication-induced psychotic disorder, or psychotic disorder due to another medical condition. * 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.