SchizophreniaNCT00824031
Study of Mental Care in Spain
An observational study of Schizophrenia, run by AstraZeneca at 9 sites in Spain.
Trial summary
Non-interventional, multicenter, cross-sectional study to evaluate the mental care received by schizophrenic patients and their caregivers in Spain irrespective of the drug prescribed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 76 participants
- Where
- 9 sitesSpain
- Study dates
- Jan 2009to Jul 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged 18-year old or older who has been diagnosed as schizophrenia
Who may be able to join
- Schizophrenia (DSM-IV criteria)
- Attended to the mental care units for the first time in 2006
Who cannot join
- Participation in another clinical trial
- Other criteria that according to the medical criteria make difficult the normal development of the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Research Site
Avilés, Principality of Asturias
Research Site
Bilbao, Vizcaya
Research Site
Córdoba
Research Site
Ferrol, A Coruna
Research Site
Girona
Research Site
Jerez de la Frontera, Cadiz
Research Site
La Plana, Valencia
Research Site
Madrid
Research Site
Torrejón de Ardoz, Castellon
About this study
Non-interventional, multicenter, cross-sectional study to evaluate the mental care received by schizophrenic patients and their caregivers in Spain irrespective of the drug prescribed.
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, medical mental care, caregiver, Sapin
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Camberwell's scale of Needs Analysis (CAN)
Measured: Once
Caregiver Needs Questionnaire(CNF)
Measured: Once
Secondary outcomes (1)
Health of the Nation Outcome Scales (HoNOS)
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2009
- Study completionJul 2009
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.
- More trials run by AstraZenecaThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manuel Gomez-Beneyto, Study chair, University of ValenciaAlberto Gonzalez, Study chair, Hospital Universitario Principe de Asturias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824031
- Sponsor's protocol ID
- NIS-NES-DUM-2008/4
- Status last verified
- Sep 2009
- First submitted
- 15 Jan 2009
- Last updated
- 11 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Mental Care in Spain
- ClinicalTrials.gov ID
- NCT00824031
- Acronym / sponsor ID
- NIS-NES-DUM-2008/4
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, medical mental care, caregiver, Sapin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Jan 2009 (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.
Non-interventional, multicenter, cross-sectional study to evaluate the mental care received by schizophrenic patients and their caregivers in Spain irrespective of the drug prescribed.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged 18-year old or older who has been diagnosed as schizophrenia
Key inclusion criteria (2 listed)
- Schizophrenia (DSM-IV criteria)
- Attended to the mental care units for the first time in 2006
Key exclusion criteria (2 listed)
- Participation in another clinical trial
- Other criteria that according to the medical criteria make difficult the normal development of the study
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
Camberwell's scale of Needs Analysis (CAN)
Time frame: Once
Caregiver Needs Questionnaire(CNF)
Time frame: Once
1 secondary outcome
Health of the Nation Outcome Scales (HoNOS)
Time frame: Once
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 11 Sep 2009.
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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.
Manuel Gomez-Beneyto study chair
University of Valencia
Alberto Gonzalez study chair
Hospital Universitario Principe de Asturias
9 sites 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 AstraZeneca at 9 sites in Spain.
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 2 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 11 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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?
Camberwell's scale of Needs Analysis (CAN) (time frame: Once). The study lists 2 primary outcomes in all. 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 11 Sep 2009.