Sex Differences in NMDA-enhancing Treatment of Schizophrenia
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT07122895
- Run by
- China Medical University Hospital
- People needed
- 90
- Starts
- 2025-09-16
- Expected to finish
- 2030-03-01
- Last updated by the study team
- 2025-09-17
Who can join
Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Department of Psychiatry, China Medical University Hospital — Taichung, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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