NMDA-enhancing treatment for cognitive issues in schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Hsien-Yuan Lane, M.D., Ph.D
• Email: hylane@gmail.com
• Phone: 886 4 22052121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.