RecruitingPhase 2NCT06574360

Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia

Sponsor

China Medical University Hospital

Enrollment

90 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

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 Criteria4

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