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Clinical Trials in China / NCT07122895
Recruiting Phase 2

Sex Differences in NMDA-enhancing Treatment of Schizophrenia

NCT07122895 · tracked via the Priya Life Science China tracker
Sponsor
China Medical University Hospital
Phase
Phase 2
Started
2025-09-16
Last updated
2025-09-17

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

NMDAE →Placebo Cap

NMDAE: Use of an NMDA enhancer for the treatment of negative symptoms

Placebo Cap: Use of placebo as a comparator

Study summary

Schizophrenia differs between sexes in clinical symptoms and functional outcome. Negative symptoms are the core pathology of this disease. NMDA receptor (NMDAR) dysfunction is a key factor in negative symptoms. This study aims to examine the sex difference in the efficacy of an NMDA-enhancer (NMDAE) for the treatment of negative symptoms in schizophrenia.

Eligibility

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

Primary outcome measure(s)

Trial sites (1)

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

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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 NCT07122895 on ClinicalTrials.gov ↗ ← All trials in China