NMDA-enhancing treatment for cognitive issues in schizophrenia

NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia Patients During Symptomatic Remission

This study is testing a new treatment to see if it can help improve thinking skills in people with schizophrenia who are feeling better but still have cognitive issues.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: China Medical University Hospital (Academic / other)
• Locations: 1 site (Taichung)
• Trial ID: NCT06021197 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of an NMDA-enhancer (NMDAE) in treating cognitive impairment associated with schizophrenia in patients who are in symptomatic remission. Participants will be randomly assigned to receive either the NMDAE or a placebo for 12 weeks while maintaining their current antipsychotic treatment. Cognitive function will be assessed across multiple domains at the beginning and end of the study, along with evaluations of global functioning, quality of life, and side effects. The study employs a double-blind design to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with schizophrenia who meet specific remission criteria and have been stable on antipsychotic medication for at least six months.

Not a fit: Patients who are not in remission or those who have not been stable on their antipsychotic medication may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cognitive function in schizophrenia patients, enhancing their overall quality of life.

How similar studies have performed: While the approach of enhancing NMDA receptor function is promising, this specific application in schizophrenia during remission is relatively novel and has not been extensively tested in prior studies.

Eligibility 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

Where this trial is running

Taichung

• Department of Psychiatry, China Medical University Hospital — Taichung, Taiwan (Recruiting)

Study contacts

• Study coordinator: Hsien-Yuan Lane, M.D., Ph.D

Conditions Schizophrenia; NMDA; Symptomatic remission