Sex Differences in NMDA-enhancing Treatment of Schizophrenia

Launched by CHINA MEDICAL UNIVERSITY HOSPITAL · Aug 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment aimed at improving the negative symptoms of schizophrenia, which are the challenges like lack of motivation, reduced emotional expression, and social withdrawal that often make daily life difficult. Researchers want to see if this treatment, which works by enhancing a brain system called the NMDA receptor, works differently in men and women. Understanding these differences could help tailor better treatments for people with schizophrenia.

To take part, individuals need to have a diagnosis of schizophrenia and have experienced mainly negative symptoms for at least six months. They should have been mentally stable and on the same dose of their current antipsychotic medication for at least six months before joining the study. Participants also need to be physically healthy and able to communicate well enough to complete study assessments. The trial will last about 12 weeks, during which their medication dose won’t change. People with other serious health issues, substance use problems, or depression are not eligible. Also, pregnant or breastfeeding women cannot participate. If eligible, participants can expect careful monitoring and assessments to see how well the new treatment helps with their symptoms. This study has not started recruiting yet but aims to improve understanding of how this treatment might work best for different sexes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia
• • keep stable mentally for ≥ 6 months before baseline and meet the following clinical criteria: predominantly negative symptoms for ≥ 6 months, a minimum baseline total score of 40 on the SANS, a minimum baseline score of 24 on the negative subscale of the PANSS, and a maximum score of 3 on each item of PANSS-positive subscale;
• • Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;
• • Have been keeping a fixed dose of antipsychotics for at least 6 months, and that is not allowed to change during the 12-week study period
• • Have sufficient education to communicate effectively and are capable of completing the assessments of the study
• • Agree to participate in the study and provide written informed consent
• Exclusion Criteria:
• • DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder
• • History of epilepsy, head trauma, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study
• • Clinically evident depressive symptoms or a baseline score\>7 on the Hamilton Depression Rating Scale-17 items
• • Clinically relevant parkinsonism or a baseline score \>3 on the sum of the first eight items of the Simpson-Angus Scale (SAS)
• • Pregnancy or lactation
• • Inability to follow protocol