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| Name | Class |
|---|---|
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
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Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-2, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment-resistant schizophrenia patients in a randomized, double-blind, placebo-controlled trial.
Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, many clinical trials on NMDA-enhancing agents were studied. Adjuvant NMDA-enhancing agents, including glycine, D-amino acids such as D-serine, and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms.
The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment resistant schizophrenia patients in a randomized, double-blind, placebo - controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAAOI-2 | Experimental | DAAOI-2: 500-2000mg/d |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAAOI-2 | Drug | 500-2000mg/d, oral, for 6 weeks |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale(PANSS) | baseline | |
| Positive and Negative Syndrome Scale(PANSS) | 2 weeks after the trial | |
| Positive and Negative Syndrome Scale(PANSS) | 4 weeks after the trial | |
| Positive and Negative Syndrome Scale(PANSS) | 6 weeks after the trial (The end of the trial) | |
| Assessment of Negative symptoms(SANS) | baseline | |
| Assessment of Negative symptoms(SANS) | 2 weeks after the trial | |
| Assessment of Negative symptoms(SANS) | 4 weeks after the trial | |
| Assessment of Negative symptoms(SANS) | 6 weeks after the trial (The end of the trial) |
| Measure | Description | Time Frame |
|---|---|---|
| PANSS subscales | baseline | |
| PANSS subscales | 2 weeks after the trial | |
| PANSS subscales |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, China Medical University Hospital | Taichung | Taiwan |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Drug |
oral, for 6 weeks |
|
| 4 weeks after the trial |
| PANSS subscales | 6 weeks after the trial (The end of the trial) |
| Clinical Global Impression (CGI) | baseline |
| Clinical Global Impression (CGI) | 2 weeks after the trial |
| Clinical Global Impression (CGI) | 4 weeks after the trial |
| Clinical Global Impression (CGI) | 6 weeks after the trial (The end of the trial) |
| Global assessment of function (GAF) | baseline |
| Global assessment of function (GAF) | 2 weeks after the trial |
| Global assessment of function (GAF) | 4 weeks after the trial |
| Global assessment of function (GAF) | 6 weeks after the trial (The end of the trial) |
| Hamilton Depression Rating Scale (HAMD) | baseline |
| Hamilton Depression Rating Scale (HAMD) | 2 weeks after the trial |
| Hamilton Depression Rating Scale (HAMD) | 4 weeks after the trial |
| Hamilton Depression Rating Scale (HAMD) | 6 weeks after the trial (The end of the trial) |
| Quality of life scale (QOL) | baseline |
| Quality of life scale (QOL) | 2 weeks after the trial |
| Quality of life scale (QOL) | 4 weeks after the trial |
| Quality of life scale (QOL) | 6 weeks after the trial (The end of the trial) |
| "Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS] | An intergrated score from 7 domains:
| baseline |
| "Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS] | An intergrated score from 7 domains:
| 6 weeks after the trial (The end of the trial) |