Combination of NMDA-enhancing and Anti-inflammatory Treatments for Ultra-resistant Schizophrenia
Recruiting · NCT05240976 · Interventional (participants receive a specific treatment) · Lead sponsor: China Medical University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
NMDAE plus AIFANMDAE plus Placebo Cap
What this trial is about
Previous study found that some NMDA-enhancing agent was able to augment efficacy of clozapine for clinical symptoms but not cognitive function in the treatment of ultra-resistant schizophrenia. In addition, several drugs with anti-inflammatory properties have been tested in clinical trials for the treatment of schizophrenia. Whether a drug with anti-inflammatory property can strengthen the efficacy of an NMDA-enhancer (NMDAE) in the treatment of ultra-resistant schizophrenia remains unknown.
Who can take part
Age range
18 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 DSM-5 (American Psychiatric Association) diagnosis of schizophrenia
- Are treatment-resistant to standard treatments of at least two specific antipsychotics before clozapine treatment
- Are receiving adequate trials of clozapine for more than 12 weeks but without satisfactory response
- PANSS total score ≥ 70; SANS total score ≥ 40
- Have sufficient education to communicate effectively and are capable of completing the assessments of the study
- Agree to participate in the study and provide 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 significant laboratory screening tests (including blood routine, biochemical tests)
- Pregnancy or lactation
- Inability to follow protocol
Where it is running
1 location listed.
- Department of Psychiatry, China Medical University Hospital - Taichung, Taiwan