Sex differences in NMDA-enhancing treatment for 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 randomized, double-blind, placebo-controlled Phase 2 trial enrolls 90 adults with schizophrenia and predominantly negative symptoms. Participants remain on their stable antipsychotic dose and are randomly assigned 2:1 to receive an NMDA-enhancer (N=60) or placebo (N=30) for 12 weeks, with equal numbers of men and women in each arm. Primary outcome is change in the Scale for Assessment of Negative Symptoms (SANS) with assessments at baseline and weeks 4, 8, and 12; secondary outcomes include PANSS-negative, CGI, quality of life, global functioning, cognitive domains, and side effects. Repeated measures will be analyzed using generalized estimating equations and standard tests for between-group comparisons.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia
* keep stable mentally for ≥ 6 months before baseline and meet the following clinical criteria: predominantly negative symptoms for ≥ 6 months, a minimum baseline total score of 40 on the SANS, a minimum baseline score of 24 on the negative subscale of the PANSS, and a maximum score of 3 on each item of PANSS-positive subscale;
* Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;
* Have been keeping a fixed dose of antipsychotics 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 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 evident depressive symptoms or a baseline score\>7 on the Hamilton Depression Rating Scale-17 items
* Clinically relevant parkinsonism or a baseline score \>3 on the sum of the first eight items of the Simpson-Angus Scale (SAS)
* 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.