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Recruiting Phase 2

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

NCT06574360 · tracked via the Priya Life Science Taiwan tracker
Phase
Phase 2
Started
2024-09-23
Last updated
2026-03-24

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

S1RA plus NMDAE →S1RA plus Placebo Cap

S1RA plus NMDAE: Use of an S1R agonist plus an NMDA enhancer for the treatment of treatment-resistant schizophrenia.

S1RA plus Placebo Cap: Use of an S1R agonist plus placebo as a comparator

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change of Positive and Negative Syndrome Scale (PANSS) — week 0, 2, 4, 6, 8
    Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome.

Trial sites (1)

FacilityCityRegionStatus
Department of Psychiatry, China Medical University Hospital Taichung Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06574360 on ClinicalTrials.gov ↗ ← All trials in Taiwan