Combining two treatments for schizophrenia
Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia
This study is testing if a new combination of two treatments can help people with schizophrenia who haven't responded well to other medications.
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 | NCT06574360 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a combined treatment approach using a sigma-1 receptor agonist and an NMDA receptor enhancer for patients with treatment-resistant schizophrenia. Participants will be randomly assigned to receive either the combination treatment or a placebo while maintaining their current antipsychotic medications. The study will assess clinical performance and side effects over a 12-week period, with cognitive functions evaluated at the beginning and end of the treatment. The goal is to determine if the combination therapy offers greater benefits than the sigma-1 receptor agonist alone.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with schizophrenia who have not responded adequately to at least two different antipsychotic medications.
Not a fit: Patients with intellectual disabilities or substance use disorders 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: Previous studies have shown some success with NMDA receptor enhancers in schizophrenia, but this specific combination approach is novel.
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 (excluding clozapine) * 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 8-week trial * PANSS total score \>70 * Hamilton Depression Rating Scale-17 items (HAMD) \<7 * Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant. * Have sufficient education to communicate effectively and are capable of completing the assessments of the study. * 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, central nervous system diseases or mental disorders other than schizophrenia (including major depressive disorder, bipolar disorders, persistent depressive disorder, obsessive-compulsive disorder) * Pregnancy or lactation * Inability to follow protocol
Where this trial is running
Taichung
- Department of Psychiatry, China Medical University Hospital — Taichung, Taiwan (Recruiting)
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.