RecruitingPhase 2NCT07122895

Sex Differences in NMDA-enhancing Treatment of Schizophrenia

Sponsor

China Medical University Hospital

Enrollment

90 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

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

Min Age: 20 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria6

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

Interventions

DRUGNMDAE

Use of an NMDA enhancer for the treatment of negative symptoms

DRUGPlacebo Cap

Use of placebo as a comparator

Locations(1)

Department of Psychiatry, China Medical University Hospital

Taichung, Taiwan

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NCT07122895

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