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

NCT04917302 · tracked via the Priya Life Science China tracker

Sponsor

China Medical University Hospital

Phase

Phase 2

Started

2020-10-13

Last updated

2025-02-19

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

NMDAE plus AIFANMDAE plus Placebo Cap

NMDAE plus AIFA: Use of an NMDA enhancer plus a drug with anti-inflammatory property for the treatment of schizophrenia.

NMDAE plus Placebo Cap: Use of an NMDA enhancer plus placebo as a comparator

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Change of Positive and Negative Syndrome Scale (PANSS) — week 0, 2, 4, 6, 9, 12]
Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome.

Trial sites (1)

Facility	City	Region	Status
Department of Psychiatry, China Medical University Hospital	Taichung	Taiwan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04917302 on ClinicalTrials.gov ↗ ← All trials in China