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Clinical Trials in Taiwan / NCT05240976
Recruiting Phase 2

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

NCT05240976 · tracked via the Priya Life Science Taiwan tracker
Sponsor
China Medical University Hospital
Phase
Phase 2
Started
2022-02-23
Last updated
2026-03-24

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

NMDAE plus AIFAAll Nmdae trials (11) →All AIFA trials (2) →NMDAE plus Placebo Cap

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

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

Study summary

Previous study found that some NMDA-enhancing agent was able to augment efficacy of clozapine for clinical symptoms but not cognitive function in the treatment of ultra-resistant schizophrenia. In addition, several drugs with anti-inflammatory properties have been tested in clinical trials for the treatment of schizophrenia. Whether a drug with anti-inflammatory property can strengthen the efficacy of an NMDA-enhancer (NMDAE) in the treatment of ultra-resistant schizophrenia remains unknown.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia * Are treatment-resistant to standard treatments of at least two specific antipsychotics before clozapine treatment * Are receiving adequate trials of clozapine for more than 12 weeks but without satisfactory response * PANSS total score ≥ 70; SANS total score ≥ 40 * Have sufficient education to communicate effectively and are capable of completing the assessments of the study * 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, 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 cognitive function — Week 0, 12
    The measure is the composite from multiple measures. All tests have no unit. For the domain (a. and c.) with more than one test, a composite T score will be calculated by standardizing the average of each T score. Furthermore, a global composite score (for all seven domains) and a neurocognitive composite score (for the first 6 domains) will be also calculated by standardizing the average of the T score of each domain (Lane HY et al, JAMA Psychiatry 2013). Ten tests for assessing 7 cognitive domains: 1. speed of processing (assessed by Category Fluency, Trail Marking A, WAIS-III Digit Symbol-Coding); 2. sustained attention (Continuous Performance Test); 3. working memory: verbal (digit span) and nonverbal (spatial span); 4. verbal learning and memory (WMS-III, word listing); 5. visual learning and memory (WMS-III, visual reproduction); 6. reasoning and problem solving (WISC-III, Maze); 7. social cognition (MSCEIT Version 2)

Trial sites (1)

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

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Other trials for the same condition

Monotherapy of an NMDA Enhancer for Schizophrenia Recruiting
A Study of Brenipatide in Adult Participants With Schizophrenia Recruiting
Dual Modulation of Sigma-1 and NMDA Receptors in the Treatment of Schizophrenia Recruiting
NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia Recruiting
A Computational Neuroscience Perspective on the Shared Social Cognitive Deficits of Autism and Schizophrenia Active, not recruiting
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 NCT05240976 on ClinicalTrials.gov ↗ ← All trials in Taiwan