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Study was unable to be started due to unavailability of study medication.
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The purpose of this research is to see if daily combination treatment of L-arginine and Kuvan changes brain chemistry in people experiencing schizophrenia as measured by MRS brain scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-arginine and Kuvan | Experimental | Open-label single arm study, all participants will be in this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-arginine | Drug | 6000mg of L-arginine daily for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in brain chemistry as measured by 1H-MRS scans | To demonstrate that L-arginine and tetrahydrobiopterin (BH4) combination targets and alters brain chemistry in patients with TRS (target engagement). The investigators hypothesize that two-week treatment of L-arginine and Tetrahydrobiopterin (as Kuvan) will alter glutamate and GABA levels measured with proton magnetic resonance spectroscopy (1H-MRS). | 14 days |
| Incidence of Treatment-Emergent Adverse Events as assessed by patient report | The study doctor in conjunction with the study coordinator will conduct a diagnostic interview with the subject at each visit to record the incidence of treatment-emergent adverse events as assessed by patient report. | 14-days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Symptom scale (PANSS) from Baseline to Day 14 | The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at until day 14. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoduo Fan | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Medical School | Worcester | Massachusetts | 01655 | United States |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001120 | Arginine |
| C003402 | sapropterin |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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Open-label single arm pilot trial of L-arginine and Kuvan combination therapy
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| Sapropterin Dihydrochloride |
| Drug |
800mg of Kuvan daily for 14 days |
|
|
| 14 days |
| Evaluate changes in NO bioavailability in breath from Baseline to Day 14 | Will measure change in NO bioavailability in breath using a Sievers NO Analyzer (NOA280i). | 14 days |
| Change in blood levels of glutathione (GSH) from baseline to day 14. | Blood levels of glutathione (GSH) (uM) will be measured at baseline and day 14 via blood draw. Values of the this biomarker correspond to the bodies inflammatory and oxidative stress response. The results will be analyzed and compared from baseline to day 14 to measure for the effect of L-arginine and BH4 combination treatment on the body's inflammatory and oxidative stress response regulation. | 14 days |
| Change in blood levels of high-sensitivity C reactive protein (hsCRP) from baseline to day 14. | Blood levels of high-sensitivity C reactive protein (hsCRP) (mg/L) will be measured at baseline and day 14 via blood draw. Values of the this biomarker correspond to the bodies inflammatory and oxidative stress response. The results will be analyzed and compared from baseline to day 14 to measure for the effect of L-arginine and BH4 combination treatment on the body's inflammatory and oxidative stress response regulation. | 14 days |
| Change in blood levels of Tumor Necrosis Factor (TNF-α) from baseline to day 14. | Blood levels of Tumor Necrosis Factor (TNF-α) (pg/mL) will be measured at baseline and day 14 via blood draw. Values of the this biomarker correspond to the bodies inflammatory and oxidative stress response. The results will be analyzed and compared from baseline to day 14 to measure for the effect of L-arginine and BH4 combination treatment on the body's inflammatory and oxidative stress response regulation. | 14 days |
| D000601 | Amino Acids, Essential |