Computer-based virtual reality assessments of functional capacity have shown promise as a reliable and valid way to assess individuals with multi-episode schizophrenia. However, there has been little research utilizing this innovative approach with young patients who are in the early phase of schizophrenia.

VeraSci’s proprietary Virtual Reality Functional Capacity Assessment Tool (VRFCAT) integrates virtual reality into the assessment of functioning in clinical trials. The VRFCAT is administered on a computer or our tablet-based platform, Pathway, and simulates key instrumental activities of daily living (iADLS) in a realistic and interactive virtual environment. With demonstrated sensitivity to basic functional capacity deficits, the VRFCAT was developed to improve clinical trials by detecting functionally meaningful improvements in patients’ everyday lives. The VRFCAT has numerous advantages over conventional assessments, and meets the highest psychometric and regulatory standards, with strong support from industry sponsors, NIH and FDA as a functional co-primary outcome measure.

A recently published manuscript by Ventura et al., including as a co-author VeraSci’s CEO and Co-founder Dr. Richard Keefe, extended previous findings to patients with first-episode schizophrenia. Virtual-reality–based performance was correlated with a standard test of functional capacity, indicating VRFCAT validity. Furthermore, correlations with cognitive functioning and occupational/school and social functioning indicate promise as a coprimary measure to track changes in response to treatment.

CLICK HERE to read the full manuscript: Virtual reality assessment of functional capacity in the early course of schizophrenia: Associations with cognitive performance and daily functioning by
Joseph Ventura, Tamara Welikson, Arielle Ered, Kenneth L. Subotnik, Richard S. E. Keefe, Gerhard S. Hellemann, Keith H. Nuechterlein. Early Intervention in Psychiatry. 2019;1–9.

The Schizophrenia Cognition Rating Scale (SCoRS) is a 20-item interview-based clinical assessment that evaluates cognitive deficits and the degree to which these deficits impair patients’ day-to-day functioning. It was originally developed in 2001 at Duke University Medical Center by VeraSci CEO and Co-Founder Dr. Richard Keefe and is licensed through VeraSci. The SCoRS is used in registration-level clinical trials, academic research and in clinical settings. The SCoRS contains questions about the patient’s ability to manage cognitively demanding, functionally relevant, everyday tasks.

The SCoRS items were developed to assess the following cognitive domains:• Attention

  • Memory
  • Working Memory
  • Language Production
  • Reasoning
  • Problem Solving
  • Motor Skills
  • Social Cognition

A recently published manuscript: Comprehensive review of the research employing the schizophrenia cognition rating scale (SCoRS) by Philip D. Harvey, Anzalee Khan, Alexandra Atkins, Trina M. Walker, Richard S.E. Keefe is a review of research utilizing the SCoRS that outlines the development, evaluation, validation, and implementation of the SCoRS to assess whether the scale meets the criteria as a functional co-primary measure as defined by the MATRICS-CT initiative.

The MATRICS-CT initiative was developed by the NIMH in conjunction with industry and FDA partners to offer a systematic translation (T) of the MATRICS consensus cognitive assessment battery (MCCB) and to develop a co-primary (C) measure of outcomes for clinical trials. This publication addresses the appropriateness of the SCoRS as a co-primary measure and its global applicability.

Interview-based co-primary assessments should be: 1) practical and easy to administer for a clinician or researcher; 2) validated in individuals with schizophrenia; 3) contain the relevant areas of cognition and functioning applicable to schizophrenia; 4) able to assess all phases and severity levels of schizophrenia; 5) capable of monitoring disease progression; 6) minimal burden to patients; and 7) sensitive to assess treatment effects. A review of the literature was conducted to present information on the development, psychometric properties and usage of the SCoRS. Review of the development of the SCoRS followed the parameters outlined for scale development on content expert validation and feedback.

The SCoRS shows good psychometric properties in various studies and demonstrates low burden on clinicians and patients. The items measure global concepts that do not require notable cultural modification, making international use feasible. While multiple performance-based tests in cognition and functional outcomes are available, there is a need for a multi-domain, interview-based assessment of cognitive progression and treatment response in clinical trials. The SCoRS appears to meet many of the criteria for an optimal co-primary measure for schizophrenia cognition clinical trials as defined in the MATRICS-CT initiative.

To read the full publication in Schizophrenia Research: Comprehensive review of the research employing the schizophrenia cognition rating scale (SCoRS) by Philip D. Harvey, Anzalee Khan, Alexandra Atkins*, Trina M. Walker*, Richard S.E. Keefe* CLICK HERE

Note: * VeraSci Leadership

A recently published manuscript in the Journal Schizophrenia Research by Dr. Luca Pani and Dr. Richard Keefe of VeraSci provides an overview of the regulatory and policy issues related to the treatment of CNS disorders, with a focus on attenuated psychosis syndrome (APS) and schizophrenia. Schizophrenia has undergone a reconceptualization as a psychotic spectrum disorder, rather than a progressive or continuum disorder such as Alzheimer’s Disease or Parkinson’s Disease that follow a pattern of increasing severity over time. The current diagnostic and statistical manual (DSM-5) classification of schizophrenia as a spectrum disorder has been accepted as a welcome change from DSM-IV because it reflects the genetic and neurobiological relationship between schizophrenia, schizoaffective disorder, and schizotypal personality disorder. This conceptualization also considers the clinical manifestations of being at risk for psychosis, referred to as the attenuated psychosis syndrome, or APS.

The increased focus on the prodromal stages of schizophrenia is placing increased pressure on the regulatory system. APS represents one of the earliest manifestations of the psychosis spectrum, and regulators are now realizing the importance of therapies that target these initial stages. The subsequent interest in biomarkers for the identification of patients with prodromal CNS disease is essential; however, it can be challenging due to the various molecular and environmental complexities involved. To guide treatment, regulators would prefer biomarkers linked to a drug mechanism of action and disease neurobiology to allow a disease-modifying claim within the product label. In addition, the European Medicines Agency has recently highlighted a need for the co-development of biomarkers alongside corresponding assays that can be successfully transitioned into clinical practice.

There are no approved medications for APS, and there is no established regulatory standard for the conduct of clinical trials in this area. Research into the accurate and sensitive inclusion of individuals within clinical trials, and the conduct of such trials within the global regulatory environment, requires further consideration. Moving forward, translational science should be applied to regulatory concepts and measures, and it is essential that regulatory guidelines are followed for the certification of such measures. Finally, digital technologies that enable active measurement of key endpoints in both clinical trials and real-world settings will shortly be available, paving the way for a new era in patient identification and monitoring.

Read the full Schizophrenia Research: Cognition article, Approaches to attenuated psychosis syndrome treatments: A perspective on the regulatory issues, here.

 

 

Ali Taher 1 | Vip Viprakasit 2 | Maria Domenica Cappellini 3 | Pranee Sutcharitchan 4 |Richard Ward 5 | Dalia Mahmoud 6 | Abderrahmane Laadem 6 | Anzalee Khan 7,8 |Chad Gwaltney 9 | Gale Harding 10 | Kenneth Attie 11 | Xiaosha Zhang 11 | Jun Zou 6 | Joseph Pariseau6 | X. Henry Hu 6† | Antonis Kattamis 12

Abstract
β-Thalassemia, a hereditary blood disorder caused by reduced or absent synthesis of the β-globin chain of hemoglobin, is characterized by ineffective erythropoiesis, and can manifest as nontransfusion-dependent thalassemia (NTDT) or transfusion-dependent thalassemia (TDT). Many patients with NTDT develop a wide range of serious complications that affect the survival and quality of life (QoL). Patient-reported outcomes (PRO), including health-related QoL (HRQoL), are important tools for determining patient health impairment and selecting appropriate treatment. However, there are currently no disease-specific PRO tools available to assess symptoms related to chronic anemia experienced by patients with NTDT. This study aimed to develop a new, US Food and Drug Administration (FDA)-compliant PRO of chronic anemia symptoms, the NTDT-PRO© tool, for use in patients with NTDT. Participants had a median age of 36 years (range, 18-47) and 60% were female. The initial development of the NTDT-PRO tool involved concept-elicitation interviews with 25 patients from 3 centers (in Lebanon, Greece, and Canada); subsequent interview discussions and clinical input resulted in the generation of 9 items for inclusion in the draft NTDT-PRO. Following a round of cognitive interviews involving 21 patients from 2 centers (in Lebanon and Greece), 4 items (Pain, Headaches, Ability to Concentrate, and Paleness) were removed from the draft NTDT-PRO. The final NTDT-PRO comprises 6 items that measure Tiredness, Weakness, and Shortness of Breath, with or without Physical Activity. The NTDT-PRO is a new disease-specific HRQoL tool for patients with NTDT, developed using a thorough methodology based on FDA 2009 PRO development guideline.

Follow the link below for the full article:

Taher_et_al-NTDT-PRO Development-2018-American_Journal_of_Hematology

Ali Taher 1 | Maria Domenica Cappellini 2 | Vip Viprakasit 3 | Pranee Sutcharitchan 4 |Dalia Mahmoud 5 | Abderrahmane Laadem 5 | Anzalee Khan 6,7 | Chad Gwaltney 8 |Gale Harding 9 | Kenneth Attie 10 | Xiaosha Zhang10 | Jun Zou 5 | Joseph Pariseau 5 |X. Henry Hu 5† | Antonis Kattamis 11

Abstract
This study demonstrates the quantitative characteristics of the first patient-reported outcome (PRO) tool developed for patients with nontransfusion dependent β-thalassemia (NTDT), the NTDT-PRO©. A multicenter validation study was performed over 24 weeks, involving 48 patients from Italy, Lebanon, Greece, and Thailand. Most patients were female (68.8%), with a median age
of 34.5 years (range, 18-52); 66.7% were diagnosed with β-thalassemia intermedia, and median time since diagnosis was 22 years (range, 0-43). The NTDT-PRO comprises 6 items across 2 domains (Tiredness/Weakness and Shortness of Breath [SoB]), and was valid and reliable, with good consistency. At baseline, most patients reported symptoms as present via the NTDT-PRO,
and were highly compliant, ≥90% completing the NTDT-PRO tool. In a pairwise correlation analysis, all items were positively correlated. Correlations between NTDT-PRO and existing tools— 36-Item Short Form Health Survey version 2 (SF-36v2) and Functional Assessment of Cancer Therapy-Anemia (FACT-An)—were assessed at weeks 1, 3, and 12; robust correlations were seen between SoB and SF-36v2-Vitality (rs = −0.53), and between SoB and Fact-An-Fatigue Experience (rs = −0.66) at week 1. Internal consistency was high for both Tiredness/Weakness (Cronbach alpha, 0.91) and SoB (Spearman-Brown coefficient, 0.78); intraclass correlation coefficients were high (Tiredness/Weakness, 0.88 and 0.97; SoB, 0.92 and 0.98), demonstrating stability. Further studies are required to fully support the validity of this tool, this study demonstrated the usefulness of the NTDT-PRO in the clinical setting and for longitudinal clinical research, particularly in trials where patient health-related quality of life is expected to change.

Follow the link below for the full article:

Taher_et_al-NTDT-PRO Validation-2018-American_Journal_of_Hematology

Validation of the Russian Version of the Positive and Negative Syndrome Scale (PANSS-Ru) and Normative Data

by Evgenia Ivanova, PhD; Anzalee Khan, PhD; Lora Liharska, MS; Alexander Reznik, MD, PhD; Sergey Kuzmin, MD; Olga Kushnir, MD, PhD; Alexey Agarkov, MD, PhD; Nikolay Bokhan, MD, PhD; Tatiana Pogorelova, MD, PhD; Olga Khomenko, MD; Ksenia Chernysheva, MD, PhD; Margarita Morozova, MD, PhD; George Rupchev, PhD; Taisia Lepilkina, PhD; Alexander Ozornin, MD, PhD; Nina Ozornina, MD, PhD; Nikolay Govorin, MD, PhD; Anna Malakhova, MD, PhD; Natalia Hmara, MD; Aksana Shylava, MD, PhD; Artsiom Hryhoryeu, MD; Nataljya Ivanchikova, MD; Irina Raevskaya, MD; Pavel Gusak, MD; Marina Skugarevskaya, MD, PhD; and Lewis A. Opler, MD, PhD

Drs. Ivanova and Khan and Ms. Liharska are with VeraSci (Neurocog Trials) in Durham, North Carolina. Dr. Ivanova is also with Cronos CCS in Lambertville, New Jersey. Dr. Khan is also with Nathan S. Kline Institute for Psychiatric Research in Orangeburg, New York. Dr. Reznik is with Moscow Regional Clinical Psychiatric Hospital No. 5 in Moscow, Russia. Dr. Kuzmin is with the Smolensk Regional Clinical Psychiatric Hospital, Smolensk, Russia. Dr. Kushnir is with St. Nicholas Psychiatric Hospital in St. Petersburg, Russia.Drs. Agarkov, Bokhan, Pogorelova, Chernysheva, and Khomenko are with the Mental Health Research Institute of Tomsk National Research Medical Center of the Russian Academy of Sciences in Tomsk, Russia. Drs. Morozova, Lepilkina, and Rupchev are with the Mental Health Research Center of the Russian Academy of Medical Science in Moscow, Russia. Drs. Ozornin and Ozornina are with Regional Clinical Psychiatric Hospital named after V.H. Kandinsky in Chita, Russia. Dr. Govorin is with the Chita State Academy of Medicine in Chita, Russia. Dr. Malakhova is with the Sverdlovsk Regional Clinical Psychiatric Hospital in Ekaterinburg, Russia. Drs. Shylova and Hmara are with Gomel State Medical University in Gomel, Belarus. Drs. Hryhoryeu, Ivanchikova, Raevskaya, and Gusak are with the Gomel Regional Psychiatric Hospital in Gomel, Belarus. Dr. Skugarevskaya is with the Republican Research and Practical Center for Mental Health in Minsk, Belarus. Dr.
Opler was with Long Island University in Brooklyn, New York (†deceased).

Funding: This study was financially supported by Prophase, LLC (New York, NY) from 2011 to 2015.

Disclosures: The authors have no conflicts of interest relevant to the content of this article.

Innov Clin Neurosci. 2018;15(9–10):32–48


Abstract: Objective: The Positive and Negative Syndrome Scale (PANSS) is widely used to assess psychopathology. The Russian version (PANSS-Ru) has not been validated, and normative data for the Russian-speaking population currently do not exist. The aims of this study were to 1) complete linguistic validation for the PANSS-Ru, 2) perform psychometric validation of the Russian translation, and 3) present norms for the Russian and Belarusian population. Design: Validation and norms of the PANSS-Ru occurred in three stages—Stage I: linguistic validation; Stage II: psychometric validation of the translated version for 40 inpatients with schizophrenia and other psychoses; and Stage III: norms for 533 census-matched inpatients, outpatients, and healthy control subjects. Results: The rating criteria (PANSS-Ru), interview guide (SCI-PANSS-Ru), informant questionnaire (IQ-PANSS-Ru), and scoring form (PANSS QuikScore-Ru) were linguistically and psychometrically validated. Convergent validity between the PANSS subscale scores and total score with the Clinical Global Impressions-Severity Scale (CGI-S) were moderate (r=0.41–0.60) to high (r=0.61–0.80). Cronbach’s alpha (0.88) verified internal consistency, and intra-class correlation coefficient (ICC) comparisons had a range of 0.83. Percentile normative data collected from 533 subjects are presented. Conclusion: This is the largest population-based study providing linguistic and psychometric validation of the PANSS-Ru. Normative data can provide clinicians with a benchmark of psychopathology and inform the efficacy of treatment interventions.

Keywords: Schizophrenia, Positive and Negative Syndrome Scale (PANSS), psychometric validation, normative data, Russia-Belarus

 

To read the full article please follow the link below:

Validation of the Russian Version of the Positive and Negative Syndrome Scale (PANSS-Ru) and Normative Data