Tests an NMDA-enhancing drug for negative symptoms of schizophrenia, by sex
Tests an NMDA-enhancing drug against placebo for negative symptoms in schizophrenia.
Plain-language title generated from the registry record
Registry title: Sex Differences in NMDA-enhancing Treatment of Schizophrenia
Key facts
- Where
- Taichung, TaiwanSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 65 years old?
Source: NCT07122895, who can take part
Where in Taiwan
- Department of Psychiatry, China Medical University HospitalTaichung, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- China Medical University Hospital
- Trial code
- NCT07122895
- Record updated
- 17 September 2025
- Original description
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.Read full original descriptionShow less
Sex Differences in NMDA-enhancing Treatment of Schizophrenia
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.
Inclusion: 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: 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.