NCT07122895RecruitingPhase 2
Sex Differences in NMDA-enhancing Treatment of Schizophrenia
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 8 Aug 2025
- Start date
- 16 Sept 2025
- Primary completion date
- Dec 2029
- Lead sponsor
- China Medical University Hospital
- Diseases
- Schizophrenia
- NCT number
- NCT07122895
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 16 Sept 2025 to the primary completion date, Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychiatry, China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.