SchizophreniaNCT02246283
Schizophrenia for "Life" - a Registry and Interview Study Among Elderly With Lifelong Schizophrenia
An observational study of Schizophrenia, run by Kjeld Andersen at 1 site in Denmark.
Trial summary
The elderly demographic is on the rise - and this includes elderly living with schizophrenia. Yet very little is known about their lives, how they cope with their condition and how it develops over time. Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Schizophrenia
- How many people
- 10,404 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Dec 2017
- 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 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Registry study: A nationwide register cohort study (1970-79) identifying psychiatric admissions (aged 18-40), who were registered with a schizophrenia diagnosis. Several Danish registers are applied. Interview study: A cross-sectional survey where 150 randomly drawn surviving members of the register cohort resident in the Region of Southern Denmark will be interviewed on the basis of internationally validated assessment tools.
Who may be able to join
- Initial schizophrenia diagnosis between the ages 18-40 (both incl) in the period 1970-1979 (both incl) Interview study: Residence in Region of Southern Denmark
Who cannot join
- Interview study: Mental retardation
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit of Psychiatry, Psychiatric Unit Odense - University function
Odense C, 5000
About this study
The elderly demographic is on the rise - and this includes elderly living with schizophrenia. Yet very little is known about their lives, how they cope with their condition and how it develops over time.
Research in this patient-group is sparse; overall there seem to be a tendency for elderly patients to manifest fewer psychotic symptoms and experiencing an increase in the psychological quality of life with older age. Opinions are divided on the degree and extent to which this tendency reflects remission and/or recovery in older patients.
Read more
In order to identify factors associated with a positive outcome we:
- Investigate the course and the outcomes of the illness over the lifespan, as well as the life course and outcomes.
- Investigate the current status of mental and physical health, quality of life as well as functional competence of elderly (55+ yr) with schizophrenia.
Also the investigators
- Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type 1 diabetes (a chronic somatic illness).
This study will yield vital insights into how schizophrenia develops over time, isolating factors that determine how well patients fare. The perspective is to advance knowledge of elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the interventions offered to this group.
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, elderly, lifelong, quality of life, register, questionaire
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Ageing with schizophrenia
Prognosis measured by use of healthcare system, use of medicine, co-morbidity, mortality, causes of mortality, and socio-demographic data, including highest level of education, years of employment/un-employment, use of health- and welfare services.
Measured: up to 45 years
Secondary outcomes (2)
Quality of life
Questionnaire
Measured: 1 month
Remission
Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionDec 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kjeld Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- The Psychiatric Research Foundation in Southern Denmark, Region of Southern Denmark, University of Southern Denmark, The Danish Mental Health Foundation, The Danish Health Foundation (Helsefonden), The non-profit foundation Trygfonden., Odense Patient Data Explorative Network, Jeppe Juhl and Ovita Juhls Memorial Grant, Butcher Max Wørzner and wife Inger Wørzner's Memorial Grant
- Responsible party
- Sponsor-investigator, Kjeld Andersen, University of Southern Denmark
- Investigators
- Maria Brink, MD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246283
- Sponsor's protocol ID
- Schizophrenia-Lifelong
- Status last verified
- Jul 2018
- First submitted
- 17 Sep 2014
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schizophrenia for "Life" - a Registry and Interview Study Among Elderly With Lifelong Schizophrenia
- ClinicalTrials.gov ID
- NCT02246283
- Acronym / sponsor ID
- Schizophrenia-Lifelong
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, elderly, lifelong, quality of life, register, questionaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,404 participants (actual)
- Lead sponsor
- Kjeld AndersenUniversity, hospital or other
- Collaborators
- The Psychiatric Research Foundation in Southern Denmark, Region of Southern Denmark, University of Southern Denmark, The Danish Mental Health Foundation, The Danish Health Foundation (Helsefonden), The non-profit foundation Trygfonden., Odense Patient Data Explorative Network, Jeppe Juhl and Ovita Juhls Memorial Grant, Butcher Max Wørzner and wife Inger Wørzner's Memorial Grant
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Sep 2014 (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.
The elderly demographic is on the rise - and this includes elderly living with schizophrenia. Yet very little is known about their lives, how they cope with their condition and how it develops over time.
Research in this patient-group is sparse; overall there seem to be a tendency for elderly patients to manifest fewer psychotic symptoms and experiencing an increase in the psychological quality of life with older age. Opinions are divided on the degree and extent to which this tendency reflects remission and/or recovery in older patients.
In order to identify factors associated with a positive outcome we:
- Investigate the course and the outcomes of the illness over the lifespan, as well as the life course and outcomes.
- Investigate the current status of mental and physical health, quality of life as well as functional competence of elderly (55+ yr) with schizophrenia.
Also the investigators
- Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type 1 diabetes (a chronic somatic illness).
This study will yield vital insights into how schizophrenia develops over time, isolating factors that determine how well patients fare. The perspective is to advance knowledge of elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the interventions offered to this group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Registry study: A nationwide register cohort study (1970-79) identifying psychiatric admissions (aged 18-40), who were registered with a schizophrenia diagnosis. Several Danish registers are applied. Interview study: A cross-sectional survey where 150 randomly drawn surviving members of the register cohort resident in the Region of Southern Denmark will be interviewed on the basis of internationally validated assessment tools.
Key inclusion criteria (1 listed)
- Initial schizophrenia diagnosis between the ages 18-40 (both incl) in the period 1970-1979 (both incl) Interview study: Residence in Region of Southern Denmark
Key exclusion criteria (2 listed)
- Interview study: Mental retardation
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ageing with schizophrenia
Time frame: up to 45 years
Prognosis measured by use of healthcare system, use of medicine, co-morbidity, mortality, causes of mortality, and socio-demographic data, including highest level of education, years of employment/un-employment, use of health- and welfare services.
2 secondary outcomes
Quality of life
Time frame: 1 month
Remission
Time frame: 6 months
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 17 Jul 2018.
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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.
Maria Brink, MD principal investigator
University of Southern Denmark
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, run by Kjeld Andersen at 1 site in Denmark.
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 1 inclusion and 2 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 17 Jul 2018. 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 Denmark. 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?
Ageing with schizophrenia (time frame: up to 45 years). 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 17 Jul 2018.