NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia

• Status: Recruiting
• Trial end date: 2028-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Cognitive impairment, the core psychopathology of schizophrenia, usually persists in schizophrenia patients even during symptomatic remission. While cognitive impairment associated with schizophrenia (CIAS) is an important therapeutic target, hypofunction of N-methyl-D-aspartate receptor (NMDAR) is a key factor of CIAS. This study aims to examine the efficacy and safety of an NMDA-enhancer (NMDAE) for the treatment of CIAS in schizophrenia patients during symptomatic remission.

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

Details

• Lead Sponsor: China Medical University Hospital
• Collaborator: National Science and Technology Council, Taiwan

Criteria

Inclusion Criteria:

• Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5 -TR) diagnosis of schizophrenia

• Fulfill the Remission in Schizophrenia Working Group (RSWG) criteria for remission (Andreasen et al., 2005): each of eight items (delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, passive/apathetic social withdrawal, and lack of spontaneity and flow of conversation) in the Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1987) scoring 3 or lower for 6 months or longer; in addition, have a baseline total score of 59 or lower in the PANSS

• Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;

• Have been keeping a fixed dose of antipsychotics (excluding clozapine) for at least 6 months, and that is not allowed to change during the 12-week study period

• Have sufficient education to communicate effectively and are capable of completing the assessments of the study

• Agree to participate in the study and provide written informed consent

Exclusion Criteria:

• DSM-5-TR 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

• Pregnancy or lactation

• Inability to follow protocol