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Trial record 8 of 3313 for:    schizophrenia

Validation of a Tool for the Dimensional Assessment of Apathy in a Population Suffering From Schizophrenia. (HANDI-AS1)

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ClinicalTrials.gov Identifier: NCT03801551
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de Niort

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Diagnostic Test: 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). Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of a Tool for the Dimensional Assessment of Apathy in a Population Suffering From Schizophrenia.
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : August 4, 2020
Estimated Study Completion Date : August 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient Diagnostic Test: 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).
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).




Primary Outcome Measures :
  1. validation of the scale [ Time Frame: 1 month ]
    The DAS is a self-rated multidimensional apathy measure, consisting of 24 items assessing Executive, Initiation and Emotional dimensions of apathy. Each item was rated on a 4-point Likert scale (Hardlyever, Occasionally, Often and Almost always), the minimum score for each subscale is 0 (least apathy) and the maximum 24 (most apathy), with a total score of 72. The French Dimensional Apathy Scale (f-DAS) was firstly tested on healthy participants. The Cronbach Alpha of f-DAS was 0.71 and reflected an acceptable internal reliability.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women between 18 and 55 years old
  • According to the DSM-5 criteria: spectrum of schizophrenia and other psychotic disorders (excluding psychotic disorder induced by a substance, drug or other medical condition as well as schizotypal personality disorder) in relation to the medical file and confirmed by the MINI test.
  • Stable symptomatology (clinical assessment) during the month prior to inclusion
  • Substantive psychotropic treatment unchanged during the month prior to inclusion (25% change).
  • Reading and writing in French acquired.
  • Persons who received informed information about the study and who co-signed, with the investigator, a consent to participate in the study
  • After signing the consent by persons under guardianship, signed consent for participation by the tutor.
  • For persons under guardianship, signature of the consent under the curator's assistance.
  • Affiliate or Social Security Entitlement

Exclusion Criteria:

  • IQ score < 70 (intellectual disability measured by f-NA)
  • Neurological disorders of vascular, infectious or neurodegenerative origin, dyschromatopsia.
  • Taking somatic drugs with a cerebral or mental impact (eg corticosteroids).
  • Resistance to neuroleptics.

Addiction to cannabis, alcohol or other substances (> 2 / week) according to DSM-5 criteria, except tobacco.

  • Simultaneous participation in a remediation program targeting neurocognitive deficits.
  • Refusal of consent of the person.
  • For persons under guardianship: refusal of consent of the legal representative for participation in this study.
  • For persons under curatorship: no information of the legal representative for participation in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801551


Contacts
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Contact: LISE M'BAREK 549 783 062 ext +33 lise.mbarek@ch-niort.fr

Locations
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France
Centre Hospitalier Esquirol Not yet recruiting
Limoges, France, 87025
Contact: Emilie LEGROS-LAFARGE, Doctor         
Centre Hospitalier de Niort Recruiting
Niort, France, 79021
Contact: Lise M'BAREK    549 783 062 ext +33    lise.mbarek@ch-niort.fr   
Sponsors and Collaborators
Centre Hospitalier de Niort
Investigators
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Study Director: LISE M'BAREK Centre Hospitalier de Niort - France

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Responsible Party: Centre Hospitalier de Niort
ClinicalTrials.gov Identifier: NCT03801551     History of Changes
Other Study ID Numbers: CH-NIORT-CREHPSY-01-2017
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier de Niort:
apathy
schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders