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)
Facility
City
Region
Status
Department of Psychiatry, China Medical University Hospital
Taichung
Taiwan
Recruiting
More China Medical University Hospital trials in China
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.
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