CASES
Research type
Research Study
Full title
Prevalence of the 2018 diagnostic Criteria of Apathy in Schizophrenia patients and its relationship with negative symptoms: a European Study (CASES)
IRAS ID
287890
Contact name
Emilio Fernandez-Egea
Contact email
Sponsor organisation
R&D Department
Clinicaltrials.gov Identifier
n/A, n/A
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Apathy is defined by lack of interest, enthusiasm or concern. It is commonly seen as a symptom in people suffering with neurological and psychiatric disorders, including schizophrenia, depression, Alzheimer disease or Parkinson’s disease, among others. In schizophrenia, apathy is part of the so-called “negative symptoms” and often termed as amotivation. Indeed, the definition and terminology might differ among different specialities and disorders. Recently, a group of neurologists and psychiatrists have reached a consensus about the criteria for defining apathy in people with neurodegenerative conditions.
Here, we aim to explore how useful are these criteria for categorizing people with schizophrenia having apathy or not. We first will determine the frequency (prevalence) of these criteria. Then, we will assess the overlap between these novel criteria and the currently scales for defining apathy in schizophrenia. We will also account for potential factors that might impact the scales and apathy criteria (eg medication dose).
This study aims to harmonize the apathy criteria between specialities and also between countries, so it is a multi-centre study involving five different European countries: UK (Chief investigator), France (2), Italy, Spain and Switzerland. At least 25 volunteers (max of 50) will be recruited by site, to reach at least 150 subjects in total (max 240)
We will offer to participate in people diagnosed with schizophrenia for over a year, aged 18 to 60 years old and on stable medication. Assessments will consist of a battery of widely used scales for measuring schizophrenia symptom severity, prescribed medication and personal medical history, lasting between 60-120 minutes in total (depending on the volunteer). Analyses will include descriptive statistics of the frequency of the apathy criteria and convergent validity analysis of the apathy criteria and the negative symptoms scales, among others. Patients in the UK will be offered £10 to compensate for their participation.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0230
Date of REC Opinion
12 Oct 2020
REC opinion
Further Information Favourable Opinion