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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with chronic schizophrenia. In addition, several drugs with anti-inflammatory properties have been tested in clinical trials for the treatment of schizophrenia too. Whether combined treatment of an NMDA-enhancing agent and a drug with anti-inflammatory property can be better than an NMDA-enhancing agent alone deserves study.

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

Details

• Lead Sponsor: China Medical University Hospital
• Collaborator: Ministry of Science and Technology, Taiwan

Criteria

Inclusion Criteria:

• Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia

• Are resistant to adequate treatments of at least two antipsychotics

• Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial

• PANSS total score ≥ 70

• 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, stroke, 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