Sex Differences in NMDA-enhancing Treatment of Schizophrenia
Recruiting · NCT07122895 · Interventional (participants receive a specific treatment) · Lead sponsor: China Medical University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
NMDAEPlacebo Cap
What this trial is about
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.
Who can take part
Age range
20 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Department of Psychiatry, China Medical University Hospital - Taichung, Taiwan