Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia
Recruiting · NCT06574360 · Interventional (participants receive a specific treatment) · Lead sponsor: China Medical University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
S1RA plus NMDAES1RA plus Placebo Cap
What this trial is about
sigma-1 receptor (S1R) agonistic property have been tested in clinical trials for the treatment of schizophrenia. In addition, previous studies found that some NMDA receptor (NMDAR)-enhancing agents were able to improve clinical symptoms of patients with chronic schizophrenia. Whether combined treatment of an S1R agonist and an NMDA-enhancing agent can be better than an S1R agonist alone deserves study.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Department of Psychiatry, China Medical University Hospital - Taichung, Taiwan