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| Name | Class |
|---|---|
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
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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.
Several lines of evidence suggest that both NMDA and inflammatory hypotheses have been implicated in schizophrenia. Previous studies found that some NMDA-enhancing agents were able to augment efficacy of antipsychotics in the treatment of chronic schizophrenia. In addition, several drugs with anti-inflammatory properties have been tested in clinical trials for the treatment of schizophrenia too. Whether a drug with anti-inflammatory property can strengthen the efficacy of an NMDA-enhancer (NMDAE) in the treatment of schizophrenia remains unknow. Therefore, this study aims to compare NMDAE plus a drug with anti-inflammatory property and NMDAE plus placebo in the treatment of schizophrenia. The subjects are the patients with treatment-resistant schizophrenia who have responded poorly to two or more kinds of antipsychotics treatment. They keep their original treatment and are randomly, double-blindly assigned into two treatment groups for 12 weeks: (1) NMDAE plus Anti-inflammatory Agent (AIFA), or (2) NMDAE plus placebo. Clinical performances and side effects are measured at weeks 0, 2, 4, 6, 9, and 12. Cognitive functions are assessed at baseline and at endpoint of treatment by a battery of tests. The efficacies of NMDAE plus AIFA and NMDAE plus 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMDAE plus Anti-inflammatory Agent (AIFA) | Experimental | An NMDA enhancer plus a drug with anti-inflammatory property |
|
| NMDAE plus Placebo | Placebo Comparator | An NMDA enhancer plus Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMDAE plus AIFA | Drug | Use of an NMDA enhancer plus a drug with anti-inflammatory property for the treatment of schizophrenia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 0, 2, 4, 6, 9, 12] |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 2, 4, 6, 9, 12 |
| Positive subscale, Negative subscales, and General Psychopathology subscale of PANSS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsien-Yuan Lane, M.D., Ph.D | Contact | 886 4 22052121 | 1855 | hylane@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, China Medical University Hospital | Recruiting | Taichung | Taiwan |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| NMDAE plus Placebo Cap | Drug | Use of an NMDA enhancer plus placebo as a comparator |
|
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 |
| week 0, 2, 4, 6, 9, 12 |
| Clinical Global Impression | Assessment of general impression. Minimum value: 1, maximum value:7, the higher scores mean a worse outcome. | week 0, 2, 4, 6, 9, 12 |
| Global Assessment of Functioning | Assessment of social, occupational, and psychological function. Minimum value: 1, maximum value:100, the higher scores mean better function. | week 0, 2, 4, 6, 9, 12 |
| Hamilton Rating Scale for Depression | Assessment of depressive symptoms. Minimum value: 0, maximum value:52, the higher scores mean a worse outcome. | week 0, 2, 4, 6, 9, 12 |
| Quality of Life Scale | Assessment of life quality. Minimum value: 0, maximum value:126, the higher scores mean a better outcome. | week 0, 2, 4, 6, 9, 12 |
| Cognitive function | The measure is the composite from multiple measures. Ten cognitive tests for assessment of 7 cognitive domains:
| Week 0, 12 |