Combination of NMDA-enhancing and Anti-inflammatory Treatments for Ultra-resistant Schizophrenia

• Status: Not yet recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital
• Collaborator: National Health Research Institutes, Taiwan

Criteria

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