A Phase 2 interventional study of L-arginine and Sapropterin Dihydrochloride in Schizo Affective Disorder and Schizophrenia, sponsored by University of Massachusetts, Worcester. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by University of Massachusetts, Worcester · Phase 2, Interventional, and Treatment
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
Browse Schizophrenia studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
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Exclusion Criteria:
Open-label single arm study, all participants will be in this group
Drug: L-arginine · Drug: Sapropterin Dihydrochloride
6000mg of L-arginine daily for 14 days
800mg of Kuvan daily for 14 days
Also known as: Kuvan
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).
Time frame: 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.
Time frame: 14-days
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days
This study is withdrawn, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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University of Massachusetts, Worcester