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Background Clozapine is an effective antipsychotic for treatment-resistant schizophrenia that requires monitoring of the Absolute Neutrophil Count (ANC) due to the potential of clozapine induced neutropenia. Standard monitoring requires a routine venous draw which is considered one of the most significant barriers to patients starting or continuing the medication. This project assesses the feasibility, patient and clinician satisfaction with both venous blood drawing for ANC monitoring and a novel method for measuring ANC with a fingerstick using capillary blood. Methods During an open-label clinical trial of clozapine, participants with schizophrenia received both a venous blood draw and a capillary finger stick at baseline, week 2 and week 4. Capillary testing was done onsite using the newly FDA Class II cleared automated diagnostic device. This device performs tests on capillary finger stick samples collected directly into the provided test strip. This works by using a microfluidic test strip channel that creates a stained monolayer of white blood cells. Multiple images are taken of the monolayer and the cells are counted and classified by computer vision-based image analysis on a cloud server. This device offers technology that provides ANC results within 5 minutes using a small drop of blood drawn in the clinic and has been found to have a correlation to reference lab results of >0.94 in over 30, 000 testings. We measured patient satisfaction using a questionnaire with a 5-point Likert Scale rating domain of pain, worry, concern about blood volume, concern for where blood is sent and irritation with blood drawing and we anonymously measured clinical team members satisfaction with an anonymous survey. The study was conducted at two sites (one inpatient hospital and one research clinic) and approved by the Institutional Review Board at the University of Maryland and respective research committees. Results We enrolled 20 participants and 20 clinical team members for the surveys. Most patients believe the doctor is able to provide better care given immediate results. They also feel the elimination of unknown people touching the blood is a benefit of fingerstick monitoring. Patients indicated that they are more likely to remain on clozapine with fingerstick testing versus venous testing. There was a trend for higher agreement that using the venous blood draw negatively impacts their health (3.2 vs 2.8, p=0.068). In terms of pain, patients indicated that venous blood monitoring was slightly painful and more worrisome than fingerstick monitoring. Clinician ratings are high with mean scores >4 for satisfaction with device, satisfaction with immediate results, advancement in treatment, and improved patient care. Discussion The device is very user friendly and technology appears to be a significant advance for clinicians. Patients do not appear to worry about having venous blood draws or fingersticks but rate their most significant concern with venous blood draws is its negative effect on their health. However, patients strongly feel the fingerstick helps their doctors and their care. The use of POC devices may decrease or eliminate a significant barrier and may help improve the use of this underused evidence-based medication. Funding: This project was funded by NIMH R01MH102215 (Kelly PI). Athelas provided the Athelas One devices for two locations but provided no funding for the project.

Background: Approximately one-third of people with schizophrenia have elevated levels of antigliadin antibodies of the immunoglobulin G type (AGA IgG) — a higher rate than seen in healthy controls. We performed the first double-blind clinical trial of gluten-free versus gluten-containing diets in a subset of patients with schizophrenia who were positive for AGA IgG. Methods: In this pilot feasibility study, 16 participants with schizophrenia or schizoaffective disorder who had elevated AGA IgG (≥ 20 U) but were negative for celiac disease were admitted to an inpatient unit for a 5-week trial. All participants received standardized gluten-free meals and were randomized in a double-blind fashion to receive a shake containing 10 g of gluten flour or 10 g of rice flour each day. Participants were rated for psychiatric, cognitive and gastrointestinal symptoms at baseline and end point. Results: Of the 16 participants, 14 completed the 5-week trial (2 discontinued early for administrative reasons). Compared with participants on the gluten-containing diet, participants on the gluten-free diet showed improvement on the Clinical Global Impressions scale (Cohen d = −0.75) and in negative symptoms (Cohen d = −0.53). We noted no improvement in positive or global cognitive symptoms, but did observe an improvement in attention favouring the gluten-free diet (Cohen d = 0.60). Robust improvements in gastrointestinal adverse effects occurred in the gluten-free group relative to the gluten-containing group. Adverse effects were similar between groups. Limitations: This study was limited by its small sample size; larger studies are needed. Conclusion: This feasibility study suggests that removal of gluten from the diet is associated with improvement in psychiatric and gastrointestinal symptoms in people with schizophrenia or schizoaffective disorder.

Background: The prevalence of tobacco use is 2–3 times greater in people with schizophrenia than the general population. Tobacco craving is an important reason why people relapse; cessation efforts in this population have been modest. Understanding the triggers that lead to tobacco craving and potential relapse will help to target the testing of new interventions. Virtual reality (VR) platforms can expose smokers to multisensory tobacco cues/triggers by immersion into an environment where they can see and smell tobacco-related cues and interact in virtual social environments. It is hypothesized that smokers who heavily identify environmental triggers to smoking urges may be more likely to respond to these types of stimuli.

The goal of the present study was to demonstrate that the analytical assay of interest can detect antipsychotics in human urine specimens.Forty inpatients treated with haloperidol, quetiapine, risperidone, or olanzapine were recruited to participate in a one visit study. During the study visit, demographic and clinical information was collected as well as one urine sample that was forwarded to the Ameritox Laboratory and assayed for the presence of antipsychotic medications and/or metabolites. Urine samples were analyzed to determine detection sensitivity for four antipsychotic medications and their metabolites (risperidone, quetiapine, olanzapine, and/or haloperidol) using Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry.All urine samples produced positive results for the antipsychotic(s) the participants were known to be taking. Urine concentrations (level of quantification) for parent drugs ranged from25-417 ng/mL for haloperidol,25-4017 ng/mL for quetiapine, 0-997 ng/mL for risperidone, and 57-700 ng/mL for olanzapine.The analytical assay produced by Ameritox, Ltd using Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry can qualitatively detect antipsychotics in human urine specimens. The present study highlights the potential utility of the urine assay to help monitor adherence to antipsychotic medications.

Because patients receiving antipsychotics are at increased risk for coronary heart disease, standards of care for such patients now include periodic glucose and lipid testing. The objective of this study was to examine rates of glucose and lipid monitoring among adult Medicaid patients initiated on antipsychotic therapy.California Medicaid (Medi-Cal) claims of 6601 patients identified as "new" antipsychotic users between July 1, 2004 and June 30, 2005 were analyzed. Rates of glucose and lipid testing were compared for 6 months prior to and post-initiation of antipsychotic therapy. Odds ratios (ORs) for testing associated with first-generation antipsychotic (FGA) and second-generation antipsychotic (SGA) use were determined while controlling for patient level factors.In a multivariate analysis, SGA patients were more likely than FGA patients to undergo glucose testing (OR, 1.38; 95% confidence interval [CI], 1.13 to 1.70; P.01) and lipid testing (OR, 1.43; 95% CI, 1.14 to 1.81; P.01), respectively. SGA patients were also more likely than FGA patients to receive both glucose and lipid testing in the 6 months following initiation of antipsychotic treatment (OR, 1.40; 95% CI, 1.11 to 1.79, P.01).Although increases in glucose and lipid testing rates were observed among Medi-Cal patients after initiation of antipsychotic therapy, recommended monitoring does not appear to occur universally in this population. Interventions to increase monitoring of these patients are warranted.