SchizophreniaCSANCT02884739
Mental Healthcare in Older Adults With Schizophrenia
An observational study of Schizophrenia and Chronic Psychiatric Disorder, run by CHU de Reims at 1 site in France.
Trial summary
As in the general population, there is a gradual and steady increase in life expectancy of patients with schizophrenia. But this increase is at a smaller scale, with a rate of premature death that is still 2 to 3 times higher than that found in the general population. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Schizophrenia, Chronic Psychiatric Disorder
- What is being tested?
- Data collection
- How many people
- 685 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Jul 2018
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with schizophrenia and patients with chronic psychiatric disorder other than schizophrenia were included
Who may be able to join
- Men or women aged than 60 years with a diagnosis of schizophrenia, according to the DSM-IV criteria
- Men or women aged than 60 years with chronic psychiatric disorder other than schizophrenia
- Patients consenting to participate to the study
- Patients enrolled in the national healthcare insurance program
Who cannot join
- -Disease affecting the central nervous system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Mortality and Its Associated Factors in Schizophrenia Patients Older Than 60 Years
As in the general population, there is a gradual and steady increase in life expectancy of patients with schizophrenia. But this increase is at a smaller scale, with a rate of premature death that is still 2 to 3 times higher than that found in the general population. This excessive early mortality is explained by an overrepresentation of suicide deaths, but also a higher prevalence of somatic diseases, mainly cardiovascular. But today there are only very few epidemiological data on the mortality of patients with schizophrenia, including those aged over 60 years. What are the sociodemographic and clinical characteristics (psychiatric and somatic) of these schizophrenic elderly patients? Do they benefit from a somatic follow-up adequate and systematic? What are their levels of social independence and of quality of life? the answers these questions and the description of the offer of geriatric care and of psychiatric care currently provided by different sectors of psychiatry in France is an indispensable prerequisite for any project to improve the quality of life, state of health and mortality of older patients with schizophrenia.
Read the detailed description
Evaluate prospectively over 5 years, the rates and causes of mortality in a cohort of schizophrenic patients older than 60 years, followed by adult psychiatry sectors, compared to those patients matched for sex and age and monitored by the same sectors for a chronic psychiatric disorder other than schizophrenia
- Conditions
- Schizophrenia, Chronic Psychiatric Disorder
- Being tested
- Data collection
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia | Not described Receives: Other: Data collection | |
| chronic psychiatric disorder other than schizophrenia | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death of any causes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJan 2010
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 685 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884739
- Sponsor's protocol ID
- PN08001
- Acronym
- CSA
- Status last verified
- Sep 2016
- First submitted
- 26 Aug 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
Publications
Raucher-Chene D, Hoertel N, Bera-Potelle C, Terrien S, Barriere S, Da Rin D, Tran E, Cuervo-Lombard C, Portefaix C, Limosin F. Mental healthcare in older adults with schizophrenia: results from 118 French public psychiatric departments. Int Psychogeriatr. 2015 Oct;27(10):1749-50. doi: 10.1017/S1041610215001064. Epub 2015 Jul 6. No abstract available.
PubMed 26144544
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mortality and Its Associated Factors in Schizophrenia Patients Older Than 60 Years
- ClinicalTrials.gov ID
- NCT02884739
- Acronym / sponsor ID
- CSA / PN08001
- Conditions
- Schizophrenia, Chronic Psychiatric Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 685 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 31 Aug 2016 (estimated)
- 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.
As in the general population, there is a gradual and steady increase in life expectancy of patients with schizophrenia. But this increase is at a smaller scale, with a rate of premature death that is still 2 to 3 times higher than that found in the general population. This excessive early mortality is explained by an overrepresentation of suicide deaths, but also a higher prevalence of somatic diseases, mainly cardiovascular. But today there are only very few epidemiological data on the mortality of patients with schizophrenia, including those aged over 60 years. What are the sociodemographic and clinical characteristics (psychiatric and somatic) of these schizophrenic elderly patients? Do they benefit from a somatic follow-up adequate and systematic? What are their levels of social independence and of quality of life? the answers these questions and the description of the offer of geriatric care and of psychiatric care currently provided by different sectors of psychiatry in France is an indispensable prerequisite for any project to improve the quality of life, state of health and mortality of older patients with schizophrenia.
Detailed description
Evaluate prospectively over 5 years, the rates and causes of mortality in a cohort of schizophrenic patients older than 60 years, followed by adult psychiatry sectors, compared to those patients matched for sex and age and monitored by the same sectors for a chronic psychiatric disorder other than schizophrenia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | – | Other: Data collection |
| chronic psychiatric disorder other than schizophrenia | – | Other: Data collection |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with schizophrenia and patients with chronic psychiatric disorder other than schizophrenia were included
Key inclusion criteria (4 listed)
- Men or women aged than 60 years with a diagnosis of schizophrenia, according to the DSM-IV criteria
- Men or women aged than 60 years with chronic psychiatric disorder other than schizophrenia
- Patients consenting to participate to the study
- Patients enrolled in the national healthcare insurance program
Key exclusion criteria (1 listed)
- -Disease affecting the central nervous system
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 |
|---|---|---|
| Data collection | Other | chronic psychiatric disorder other than schizophrenia, schizophrenia |
Primary outcome
Death
Time frame: 5 years
Death of any causes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Background: PubMed 26144544Raucher-Chene D, Hoertel N, Bera-Potelle C, Terrien S, Barriere S, Da Rin D, Tran E, Cuervo-Lombard C, Portefaix C, Limosin F. Mental healthcare in older adults with schizophrenia: results from 118 French public psychiatric departments. Int Psychogeriatr. 2015 Oct;27(10):1749-50. doi: 10.1017/S1041610215001064. Epub 2015 Jul 6. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Chronic Psychiatric Disorder, run by CHU de Reims at 1 site 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Death (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02884739, which also lists 1 linked publication.
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 2 Sep 2016.