The latest clinical research at a glance.


Optimizing the Assessment of CNS Side Effects of a Novel Neuropathic Pain Compound

The current study explored standardized psychometric tests to determine their ability to efficiently and sensitively detect common CNS side effects (dizziness, somnolence, sedation, and difficulties in concentration/attention) of a potent and specific novel neuropathic pain compound.

Use of Naltrexone to Block Opioid Side Effects in Healthy Volunteers: Effects of Dose and Food

A retrospective review of common adverse events (AEs) associated with morphine (headache, nausea, vomiting and sedation) was conducted across a series of inpatient bioequivalence (BE) studies that compared generic versions of morphine extended release with brand morphine extended release (Avinza®).

Rapid Development of Tolerance to Adverse Events After Oral Morphine Administration to Opiate Naïve Subjects

Tolerance to opiate adverse events (AEs) has been observed to occur with repeated dosing, but the time course of its development is not well understood. We sought to determine whether tolerance would develop to the initial, unpleasant effects of morphine after repeated exposure in opiate-naïve subjects.

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Understanding Site Preferences With eCOA Technologies Used to Increase the Reliability of Clinical Assessments: A Multi-National Survey

The goal of this investigation is to better understand site perceptions regarding these technologies in an effort to address potential shortcomings, leading to their greater usage that will enhance the overall quality of rater assessments.
This poster is written by Douglas Lytle, Ph.D., MBA, Elan A. Cohen, Ph.D., Colleen R. Rock, BA, Andrew E. Komorowsky, MS, Bethanne Friedmann, Psy.D., Michael Murphy, M.D., PhD

Examining the Impact of Ongoing Assessment Feedback on Site Rater Performance: Does Our Work Matter?

Rater training companies provide ongoing data surveillance to ensure appropriate scale administration, scoring, and protocol parameters are maintained. However, do site raters improve with ongoing surveillance?
This poster is written by Kim F. Baldwin, MA, MFT, Rolana Avrumson, MS, Elan A. Cohen, Ph.D., Bethanne Friedmann, Psy.D., ,Melissa A. Carbo, MS, Natalie C. Glaug, BA, Andrew E. Komorowsky, MS,Eleni Rapsomaniki, PhD, Colleen R. Rock, BA, Michael F. Murphy, MD., PhD.

CSF and Plasma Monoamine Profile of the Triple-Reuptake Inhibitor SEP-432 in Healthy Volunteers

Based on in-vitro binding studies, SEP-432 is a triple monoamine reuptake inhibitor with a binding affinity for NE>5HT>DA. We determined the maximal tolerated dose (MTD) of SEP-432 to be 300mg/day, and in this study characterized its monoamine profile compared with duloxetine and placebo.
This poster is written by John Sramek PharmD, Peter Bieck M.D Ph.D, Cynthia Zamora M.D, Larry W Hardy Ph.D, Todd Grinnell Ph.D, Mark Versavel M.D,Jahnavi Kharidia Ph.D, Michael Sullivan M.S, Henry Riordan Ph.D and Neal R Cutler M.D.

Dose-Proportionality, Relative Bioavailability, and Effects of Food on Bioavailability of an Immediate-Release Oxycodone HCl Tablet Designed to Discourage Tampering

The objective was to determine the dose proportionality of oxycodone in IRO-A tablets under fasted conditions. Secondary objectives were to assess the possible effects of food on the pharmacokinetics (PK) of oxycodone in IRO-A tablets.
This poster is written by Almasa Bass, Kenneth Sommerville, Robert Rolleri, Glenn Pixton, Jeffrey Stark, Cynthia Zamora, and Mark Leibowitz.

Evaluation of Beta Amyloid Loss to CSF Sample Collection and Storage Containers

The accurate quantification of CSF biomarkers is paramount in the development of AD drugs but measurement has varied due to handling and storage material characteristics. The purpose of this study was to systematically evaluate an assortment of CSF collection/storage materials in hopes of identifying those associated with the least amount of CSF beta amyloid (Aβ) loss.
This poster is written by Henry J. Riordan, Ph.D, Yoka Thomas, Neal R. Cutler, M.D, Mark Leibowitz, M.D, Kathryn Rogers, Kathryn Dawson, Ph.D., Michele Malone, Steve Unger, Ph.D, and William Nowatzke Ph.D.

Determination of Ritonavir, Saquinavir and Lopinavir in Dried Blood Spots by LC/MS/MS Comparing Different Automated Extraction Approaches

As detection sensitivity has improved substantially in recent years, collecting dried blood spots has been reconsidered for broader application instead of collecting plasma or serum. As we began to explore the utility of dried matrix spot analysis for Discovery PK applications, a decision was made to also explore other potential approaches for automating the processing of such samples.
This poster is written by Thomas Lloyd, Ravi Orugunty, Adan Orta, Andrea Butz, and Steven Hoehne.

Determination of the Serotonin Metabolite, 5-Hydroxyindoleacetic Acid (5-HIAA), in Human Cerebrospinal Fluid (CSF), Plasma, and Urine

Monitoring for serotonin in biological fluids can be a useful biomarker for a wide variety of applications. However, it can be difficult to measure the low concentrations of serotonin in human CSF and plasma. Presented here are the validation results for three methods measuring 5-HIAA in human CSF, plasma, and urine.
This poster is written by Michael P. Sullivan, Heather Rush, Anna K. Miller, and Gregory Frayne.

LC-MS/MS Method for Determination of Total Active Gentamicin in Brown Norway Rat Lung Tissue

Genatmincin has four active components and belongs to a larger family of aminoglycoside antibiotics which are highly polar and water soluble. When delivered to the lung, the measurement of lung concentrations provides assurance that drug accumulation is limited but sufficient to overcome pulmonary infections.
This poster is written by Xiaodong Zhu, M. Tan, A. Ljungqvist, G. Poch, M. Sullivan, O. Espinosa, R. Orugunty, E. Wells, and S. Unger.

The Impact of Site Characteristics on Efficacy Measures

The success of psychiatric trials hinges on the quality of data collected by sites. Data errors and discrepancies between the key efficacy measures of a double-blind, randomized, placebo-controlled, multicenter, phase II clinical trial designed for adult attention deficit/hyperactivity disorder (ADHD), were closely monitored by a panel of clinical experts.
This poster is written by Bethanne Friedmann, PsyD, Erin B. Kornsey, M.S, Kathryn Dawson, Ph.D, Henry J. Riordan, Ph.D, Michael F. Murphy, M.D, Ph.D,and Neal R. Cutler, M.D.

The Impact of Decreased Bead Count to Determine MFI Values for Total-tau, Amyloid Beta, and Phospho-tau181 in Human Cerebrospinal Fluid by Flow Based Fluorometric Immunoassay

Objectives of this poster are to summarize accuracy and precision data from an original GLP validation at 100 BC parameter (reference); re-analyze original raw data from 100 BC validation under decreased BC parameters; perform statistical analyses to compare each new set of data to 100 BC reference; and determine degree of equivalency at each BC parameter, and which BCs are optimal for purposes of analysis.
This poster is written by Bjornstal O, Rogers K, Zhang W, Delhaye R, Malone M, Unger S, Nowatzke W.

Quantitative Determination of Bosentan in Human Plasma by LC/MS/MS

Bosentan is indicated mainly for pulmonary hypertension and is a competitive antagonist of endothelin receptors. A bioanalytical assay was developed and validated for bosentan in human plasma to assess the pharmacokinetic properties of bosentan at clinical doses.
This poster is written by Melvin S. Tan, O. Espinosa, R. Orugunty and N. Bhavsar.

A Sensitive Assay for the Determination of Dopamine in Acidified Human

Dopamine is a catecholamine neurotransmitter and neurohormone, responsible for conducting signals in the central nervous system, the sympathetic nervous system, and affecting certain glands in the endocrine system. In general, catechols are extremely sensitive to oxidation, requiring acid pretreatment of samples in order to improve stability.
This poster is written by Michael P. Sullivan, Jessica Metcalf, Heather Rush, and Edward Wells.

Quantitative Determination and Validation of Serotonin in Human Plasma and Human CSF

Serotonin (5-hydroxytryptamine, 5-HT) is a neurotransmitter involved in many physiological functions (sleep, behavior regulation, hemostasis,and gastrointestinal motility). It also has a role in pathological conditions that include cancer, neurological disorders, and cardiovascular disease. Depending on the condition, certain therapies are designed to either promote serotonin availability or to inhibit it.

Exploration of Automated Sonication and Direct Elution Approaches for the Analysis of Drugs in Dried Blood Spots and Other Matrices

As detection sensitivity has improved substantially in recent years, collecting dried blood spots has been reconsidered for broader application instead of collecting plasma or serum. This paradigm shift was compelling for a variety of reasons.
This poster is written by Thomas L. Lloyd, Joseph A. Short and Perry R. Paul.

A Sensitive Assay for the Determination of DOPA and Dopamine in Human Cerebrospinal Fluid (CSF)

Dopamine is an important endogenous compound for neurological/physiological health. The relative abundance of DOPA and dopamine can be a useful biomarker for certain therapeutic applications. The low molecular weight, endogenous presence, and relatively low target concentrations of DOPA and dopamine make a quantitative method challenging in biological fluids.
This poster is written by Michael P. Sullivan, Steven Hoehne, and Heather Rush.

The Impact of Site Rater Monitoring and Refresher Training on Enrollment in a MCI Phenotype Trial

Direct supervision and ongoing training of raters at the sites by the therapeutic team resulted in better diagnostic specificity and rater reliability. This produced an increase in enrolled subjects due to improved adherence to protocol and scale specific instructions.
This poster is written by Bethanne Friedmann, PsyD, Erin B. Kornsey, MS, Michael F. Murphy, MD, PhD, and Neal R. Cutler, MD.

Validity of Semantic Memory Test as Predictor of Change in ADAS-cog Scores in MCI

There are many clinical trials evaluating disease modifying agents in subjects with mild cognitive impairment (MCI). This poster examines the predictive value of a neuropsychiatric test used to characterize the cognitive deficit in MCI in comparison to a well validated assessment commonly used in Alzheimer’s disease trials.
This poster is written by Erin B. Kornsey, MS, Bethanne Friedmann, PsyD, Michael F. Murphy, MD, PhD, and Neal R. Cutler, MD.

Determination of Endogenous Serotonin in Human Plasma

Serotonin in human plasma is an important biochemical index for diseases of the central and peripheral nervous systems and is extremely helpful in monitoring certain drug therapies. In patients where conversion to serotonin is inhibited, the concentrations can be extremely low and a significant challenge to measure. The data presented here demonstrates its ability to measure a wide range of baseline levels.
This poster is written by Michael P. Sullivan, and Orlando E. Espinosa.

Site vs. Remote Inter-Rater Reliability of the PANSS and Information Demand

The PANSS assessment is the cornerstone of efficacy analysis for a majority of clinical trials. Raters play a significant role in obtaining this data. This is typically site raters, but the use of remote raters is increasing. A multitude of studies fail to demonstrate change in symptoms based on PANSS scoring. It is critical that sources of variability among raters is minimized in order to ensure that PANSS assessments are accurate.
This poster is written by Bethanne Friedmann, PsyD, Henry Riordan, PhD, Erin Kornsey, MS, Evan Braxton, Michael F. Murphy, MD, PhD, and Neal R. Cutler, MD.

A post-hoc Examination of patient characteristics: Implications for enhanced medical surveillance

Recent studies in psychiatry have been marked by failed as well as negative trials. One contributory factor may be the enrollment of subjects that technically meet eligibility requirements including threshold scores for disease severity, who nevertheless are suboptimal candidates for study participation when viewed through a prism of historical and clinical information not captured by a study database.
This poster is written by Bethanne Friedmann, PsyD, Henry J. Riordan, Ph.D., Erin B. Kornsey, MD, Kenneth Williams, MD, Kevin Cox, MD, Neal R. Cutler, MD, and Michael F. Murphy, MD, PhD.

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