A Phase 2 interventional study of NMDAE and Placebo Cap in Schizophrenia, sponsored by China Medical University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by China Medical University Hospital · Phase 2, Interventional, and Treatment
Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing clinical symptoms and cognitive deficits and revealed favorable safety in patients with chronic schizophrenia. Of note, a substantial portion of schizophrenia patients refuse or cannot tolerate antipsychotics due to poor response or severe side effects. Therefore, this study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) as a monotherapy for the treatment of schizophrenia.
Several lines of evidence suggest that schizophrenia is associated with accelerated aging and oxidative stress may play a role. Cognitive deficits are core symptoms of accelerated aging in patients with schizophrenia and the most difficult domain to treat. Current antipsychotics have limited, if any, efficacy for cognitive function. Previous studies found that some NMDA-enhancing agent was able to augment antioxidant activity and its adjunctive therapy was better than placebo in reducing not only clinical symptoms but also cognitive deficits and revealed favorable safety in patients with chronic schizophrenia. Of note, a substantial portion of schizophrenia patients refuse or cannot tolerate antipsychotics due to poor response or severe side effects. This study aims to examine the efficacy and safety of NMDAE monotherapy for the treatment of schizophrenia. The investigators enroll patients with schizophrenia who refuse or are unable to tolerate antipsychotics due to poor response or adverse effects into a 6-week randomized, double-blind trial to receive monotherapy of NMDAE or placebo. The investigators biweekly measure clinical performances and side effects. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests. The efficacies of NMDAE and placebo will be compared.
Chi-square (or Fisher's exact test) will be used to compare differences of categorical variables and t-test (or Mann-Whitney test if the distribution is not normal) for continuous variables between treatment groups. Mean changes from baseline in repeated-measure assessments will be assessed using the generalized estimating equation (GEE). All p values for clinical measures will be based on two-tailed tests with a significance level of 0.05.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
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Exclusion Criteria:
An NMDA enhancer
Drug: NMDAE
Placebo
Drug: Placebo Cap
Use of an NMDA enhancer for the treatment of schizophrenia
Use of placebo as a comparator
Change of Positive and Negative Syndrome Scale (PANSS)
Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome.
Time frame: week 0, 2, 4, 6
Change of scales for the Assessment of Negative Symptoms (SANS) total score
Assessment of negative symptoms. Minimum value: 0, maximum value:100, the higher scores mean a worse outcome.
Time frame: week 0, 2, 4, 6
Positive subscale, Negative subscales, and General Psychopathology subscale of Positive and Negative Syndrome Scale (PANSS)
PANSS-positive: Assessment of positive symptoms. Minimum value: 7, maximum value:49, the higher scores mean a worse outcome. PANSS-negative: Assessment of negative symptoms. Minimum value: 7, maximum value:49, the higher scores mean a worse outcome. PANSS-general psychopathology: Assessment of general psychopathology. Minimum value: 16, maximum value:112, the higher scores mean a worse outcome.
Time frame: week 0, 2, 4, 6
Clinical Global Impression
Assessment of general impression. Minimum value: 1, maximum value:7, the higher scores mean a worse outcome.
Time frame: week 0, 2, 4, 6
Global Assessment of Functioning
Assessment of social, occupational, and psychological function. Minimum value: 1, maximum value:100, the higher scores mean better function.
Time frame: week 0, 2, 4, 6
Hamilton Rating Scale for Depression
Assessment of depressive symptoms. Minimum value: 0, maximum value:52, the higher scores mean a worse outcome.
Time frame: week 0, 2, 4, 6
Quality of Life Scale
Assessment of life quality. Minimum value: 0, maximum value:126, the higher scores mean a better outcome.
Time frame: week 0, 2, 4, 6
Cognitive function
The measure is the composite from multiple measures. Ten cognitive tests for assessment of 7 cognitive domains: 1. speed of processing (assessed by 3 tests: 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 (the Mayer-Salovey-Caruso Emotional Intelligence Test \[MSCEIT\] Version 2)
Time frame: Week 0, 6
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China Medical University Hospital