Combining NMDA-enhancing and antioxidant treatments for schizophrenia
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
This study is testing if a new combination of treatments can help improve symptoms for people with schizophrenia who are already on stable antipsychotic medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT04959201 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a combination of an NMDA-enhancing agent and an antioxidant drug can improve symptoms in patients with schizophrenia who are already stabilized on antipsychotic medication. Participants will be randomly assigned to receive either the combination treatment or a placebo for 12 weeks, while their original antipsychotic treatment remains unchanged. Clinical performance and cognitive functions will be assessed at multiple time points throughout the study to evaluate the efficacy of the treatments. The goal is to determine if the combined approach offers greater benefits than the NMDA-enhancer alone.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with schizophrenia who are symptomatic but stable on antipsychotic medication.
Not a fit: Patients with a history of substance use disorders, significant medical conditions, or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with schizophrenia who continue to experience symptoms despite existing treatments.
How similar studies have performed: Previous studies have shown some success with NMDA-enhancing agents in schizophrenia, but the combination with antioxidants is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia * 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 ≥ 60 * 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.