SchizophreniaHANDI-AS1NCT03801551
Validation of a Tool for the Dimensional Assessment of Apathy in a Population Suffering From Schizophrenia.
A study 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 people with Schizophrenia, run by Centre Hospitalier de Niort at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being 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).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Jul 2018to 22 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Esquirol
Limoges, 87025
Centre Hospitalier de Niort
Niort, 79021
About this study
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.
Read more
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.
- Conditions
- Schizophrenia
- Being 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).
- Keywords
- apathy, schizophrenia
- Medical subject headings
- Schizophrenia, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).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).
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Not described Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
validation of the scale
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start3 Jul 2018
- Primary completion22 Oct 2020
- Study completion22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Niort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LISE M'BAREK, Study director, Centre Hospitalier de Niort - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801551
- Sponsor's protocol ID
- CH-NIORT-CREHPSY-01-2017
- Acronym
- HANDI-AS1
- Status last verified
- Jul 2020
- First submitted
- 11 Dec 2018
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Tool for the Dimensional Assessment of Apathy in a Population Suffering From Schizophrenia.
- ClinicalTrials.gov ID
- NCT03801551
- Acronym / sponsor ID
- HANDI-AS1 / CH-NIORT-CREHPSY-01-2017
- Conditions
- Schizophrenia
- Keywords
- apathy, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Centre Hospitalier de NiortUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Diagnostic test | Patient |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LISE M'BAREK study director
Centre Hospitalier de Niort - France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study 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 people with Schizophrenia, run by Centre Hospitalier de Niort at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validation of the scale (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.