Combination of NMDA-enhancing and Anti-inflammatory Treatments for Ultra-resistant Schizophrenia
China Medical University Hospital
80 participants
Feb 23, 2022
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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 Criteria5
- 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
Interventions
Use of an NMDA enhancer plus a drug with anti-inflammatory property for the treatment of ultra-resistant schizophrenia.
Use of an NMDA enhancer plus placebo as a comparator
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05240976