NEW YORK, NY -- (Marketwired) -- 07/24/14 -- ProPhase LLC, a New York-based global provider of measurement expertise contributes a new research article, "The evolution of illness phases in schizophrenia: A non-parametric item response analysis of the Positive and Negative Syndrome Scale" (PANSS) -- featured in print this August in the premier issue of Schizophrenia Research: Cognition, an Elsevier publication.
The article details research conclusions which indicate that a distinctive cluster of symptoms is experienced by persons with schizophrenia depending on the stage of the disorder the particular patient is in. Most clinical trials in schizophrenia rely on a total score on a symptom rating scale which is based on the entire spectrum of symptoms, regardless of stage of the disorder.
Mark Opler, PhD, MPH, Chief Scientific Officer at ProPhase and co-author on the study notes, "The value of the PANSS is that it has provided a comprehensive understanding of core symptoms of schizophrenia for many years and remains the gold-standard for testing efficacy of new antipsychotics. At ProPhase, we are committed to further developing it to understand the nuances of symptom change over time from one stage of disease to another -- the study that Dr. Khan (lead author of the article) has led explicitly focuses on this crucial issue. Our findings are essential to improving the development of better treatments."
Collection of data was funded by a Federal grant, and comprised of 20 years of data from 5 observational studies aimed at cognition, functioning, and the illness course in schizophrenia conducted from 1990 to 2010. The sample consisted of 1,882 people with schizophrenia, ages 18 to 85. Senior author, Philip D. Harvey, PhD of the University of Miami Miller School of Medicine facilitated the organization of data which was then analyzed by Dr. Khan.
Using a population comprised of three different stages of schizophrenia, item response theory was utilized, to determine which symptom clusters are represented in first episodes, chronic inpatients and ambulatory patients. This is the first examination using a dataset of three distinct groups of persons with schizophrenia to identify which symptoms are more prevalent in each group.
Anzalee Khan, PhD, Senior Statistician at ProPhase LLC and lead author of the article notes, "We were able to find that patients exhibit different clusters of symptoms based on the stage of the disorder they are in. For example, findings show that first episode psychosis patients tend to experience symptom clusters in anxiety and negative symptoms while the chronic inpatient experiences symptom clusters in the disorganization, hostility and negative domains."
"The analysis shows two key items; in drug development and exploration, when primary endpoints are selected, it should be based on the population under examination, and secondly, that the need to move beyond a total score on a behavior rating scale to the symptom clusters or specific items (symptoms) is warranted," adds Dr. Khan.
Dr. Opler further elaborates, "By thinking of schizophrenia as a condition that evolves over the life course and then measuring the changes that actually matter for people in discrete stages, we take a critical step closer to supporting meaningful remission and recovery. Ultimately, this approach can be applied to many disease areas, including Alzheimer's Disease and dementia, mood disorders, multiple sclerosis, Fragile X Syndrome -- these are neither homogenous nor unchanging. The life course concept may affect how we conduct clinical trials by reframing and targeting treatments to test their effectiveness for specific phases of disease -- and in turn help guide clinicians with evidence based on the concept of life course change. The call to action we should emphasize for people caring for persons with schizophrenia is that the symptoms and experiences they are having today will change. The scientists and clinicians engaged in creating new interventions have a deep responsibility to challenge our own understanding and move beyond limited views of these complex conditions."
About ProPhase LLC
ProPhase is a New York-based global provider of specialty services focusing on the use of applied measurement in CNS (psychiatry, neurology and rare/orphan diseases) as well as other indications in the healthcare spectrum which require calibration of observational assessment. We work to transform measurement science in clinical trials through collaboration and evidence-based innovation to improve outcomes for all stakeholders.
For more information, visit www.prophase.com.