About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- NMDAE plus AIFA
- NMDAE plus Placebo Cap
Treatment groups
Sponsors and collaborators
China Medical University Hospital
Lead sponsor
National Health Research Institutes, Taiwan
Collaborator