NCT03801551: HANDI-AS1

Validation of a Tool for the Dimensional Assessment of Apathy in a Population Suffering From Schizophrenia.

Completed NA Last updated 23 October 2020

What this trial tests

NA trial testing Validate according to psychometric criteria, a dimensional measure of apathy in a population suffering from schizophrenia spectrum disorder and other psychotic disorders (according to DSM-5 criteria). in Schizophrenia in 105 participants. Completed in 22 October 2020.

Timeline

3 July 2018

Primary endpoint
22 October 2020

22 October 2020

Quick facts

Lead sponsor	Centre Hospitalier de Niort
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	105
Start date	3 July 2018
Primary completion	22 October 2020
Estimated completion	22 October 2020
Sites	2 locations across France

Drugs / interventions tested

• Validate according to psychometric criteria, a dimensional measure of apathy in a population suffering from schizophrenia spectrum disorder and other psychotic disorders (according to DSM-5 criteria).

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →

Sponsor

Centre Hospitalier de Niort

Who can join

Adults 18 to 55, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Schizophrenia affects about 1% of the world's population. According to the WHO, it was one of the ten most worrying pathologies of the twenty-first century. The situation of psychic disability that results impacted the entire life course. This disease is characterized by positive symptoms (delirium, hallucination, psychotic agitation) and negative symptoms and disorganization (destructuring of thought, language and behavior). Cognitive disorders are easily measurable in the spectrum of schizophrenia and are quantifiable with some tools to measure the level of performance of the individual in different areas.

In these patients apathy is found in one out of two cases (prevalence of 51%), so it is a widespread negative symptom. Apathy corresponds to a pathology of voluntary action that can exist in different forms, resulting from the alteration of one or more mechanisms. It is a predictor of functional outcomes, regardless of positive symptoms or depression.

Studies of people with head injuries have found a link between frontal cognitive impairment and apathy. The recognition, the identification of the dimensional mechanisms of apathy and the understanding of the links with cognitive disorders are therefore a major issue in the improvement of the functional prognosis. Moreover, these mechanisms are currently little studied in the spectrum of schizophrenia.

There are currently questionnaires to show the presence or absence of apathy, such as the Apathy Evaluation Scale or the Lille Apathy Rating Scale. However most scales offer a global apathy score and the proposed treatments are limited due to the difficulty in identifying the dimensions and understanding of the underlying mechanisms of their own.

The potentiality of apathy to become a source of disability is now widely recognized. It is therefore important to consider the expression of this handicap in terms of the repercussions that this disorder may have on the daily lives of patients. There are questionnaires to measure the functional autonomy of patients with a psychic disorder. Apathy is also an obstacle to supporting patients in psychiatry.

The lack of knowledge and underestimation of apathy and its mechanisms in schizophrenia, in addition to overworking the psychiatric health sector, favor a drift towards the institutionalization of the person, with its medico-economic consequences on the system.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.