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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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The purpose of this study is to determine whether individuals with schizophrenia who will take a high dose of the B-vitamins folate, B12 and pyridoxine, may experience improvement in their symptoms.
Individuals with schizophrenia often experience disturbing residual symptoms, even with the best available current treatments. Homocysteine, normally found in the body, can interfere with NMDA-glutamate receptor function, and this might be responsible for some of the symptoms of schizophrenia. This double-blind protocol will have study participants who suffer from schizophrenia take either a high-dose combination of folate, B12 and pyridoxine (a combination that can lower homocysteine in the body) or placebo for three months. Clinical measures (e.g., PANSS, CGI) will be taken to determine whether those taking the vitamin combination experience clinical benefit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | vitamin capsule |
|
| B | Placebo Comparator | placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsule with folate, Vitamin B12 & pyridoxine | Dietary Supplement |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| blood homocysteine levels | 12 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| CGI (Clinical Global Improvement) | 12 weeks after baseline | |
| CDSS (Calgary Depression Scale for Schizophrenia) | 12 weeks after baseline | |
| WAIS-II Memory Scale (Immediate and Delayed) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William M Greenberg, M.D. | The Nathan Kline Institute for Psychiatric Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Nathan Kline Institute for Psychiatric Research | Orangeburg | New York | 10962 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| D011736 | Pyridoxine |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| Other |
placebo capsule |
|
| 12 weeks after baseline |
| WAIS Digit Symbol-Coding | 12 weeks after baseline |
| Wisconsin Card Sorting Test | 12 weeks after baseline |
| WAIS-II Letter-Number Sequencing Subtest | 12 weeks after baseline |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D025101 | Vitamin B 6 |
| D010847 | Picolines |
| D011725 | Pyridines |