SchizophreniaCARE INCT00617214
Schizophrenic Patients Taking Part in Integrated Care Program
An observational study of Schizophrenia and Schizoaffective Disorder, run by AstraZeneca at 14 sites in Germany.
Trial summary
Purpose of this non-interventional study (NIS) is to assess the effect of the participation in an integrated care program on treatment outcomes in patients treated with Seroquel for schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreni-form Disorder
- How many people
- 20 participants
- Where
- 14 sitesGermany
- Study dates
- Jan 2008to Dec 2008
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatient department from clinics or private practices
Who may be able to join
- Outpatients suffering from schizophrenia, schizoaffective disorder, schizophreni-form disorder, delusional disorder or psychotic disorder not otherwise specified
- Age 18 - 65 years
- Current stable treatment with Seroquel according to SmPC since at least 2 months
- Given consent to take part in an integrated care program prior to study startWritten informed consent to take part in this NIS
Who cannot join
- Presence of any contraindication as described in the SmPC
- Cancellation of participation in the integrated care program
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Research Site
Ahrweiler
Research Site
Berlin
Research Site
Bonn
Research Site
Hamburg
Research Site
Mannheim
Research Site
Mittweida
Research Site
München
Research Site
Münster
Research Site
Oldenburg
Research Site
Ottobrunn bei München
Research Site
Spremberg
Research Site
Stolberg
Research Site
Werneck
Research Site
Zittau
About this study
Official title: Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Non-interventional Study
Purpose of this non-interventional study (NIS) is to assess the effect of the participation in an integrated care program on treatment outcomes in patients treated with Seroquel for schizophrenia.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreni-form Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified
- Keywords
- Schizophrenia, Integrated care program, Seroquel
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Paranoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All | Schizophrenic outpatients who are treated with Seroquel IR and who are additionally intended to start with an integrated care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Well-Being measured via SWN patient questionnaire
Measured: 6 month period of observation,4 assessments
Secondary outcomes (3)
Quality of Life and patient's satisfaction measured by Q-LES-Q-18 and CSQ-8
Measured: 6 month period of observation, 1 assessment at end of NIS
Symptomatic and functional outcome measured by CGI-S, PANSS-8, GAF, EQ-5D and VOI
Measured: 6 month period of observation, 4 assesments
Compliance and health economic aspects measured by MARS, days of hospitalization, productivity loss
Measured: 6 month period of observation, 4 assesments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Difficulty finding eligible sites/patients:current situation in health policy cause negative effects on existing/planned contracts for integrated care programs
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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- acromion GmbH
- Investigators
- Sandra Liedtke, MD, Study director, AstraZenecaMartin Lambert, PD, MD, Principal investigator, University of Hamberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617214
- Sponsor's protocol ID
- NIS-NDE-SER-2007/1
- Acronym
- CARE I
- Status last verified
- Oct 2008
- First submitted
- 5 Feb 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Non-interventional Study
- ClinicalTrials.gov ID
- NCT00617214
- Acronym / sponsor ID
- CARE I / NIS-NDE-SER-2007/1
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreni-form Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified
- Keywords
- Schizophrenia, Integrated care program, Seroquel
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty finding eligible sites/patients:current situation in health policy cause negative effects on existing/planned contracts for integrated care programs
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- acromion GmbH
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 Feb 2008 (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.
Purpose of this non-interventional study (NIS) is to assess the effect of the participation in an integrated care program on treatment outcomes in patients treated with Seroquel for schizophrenia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All | – | –Schizophrenic outpatients who are treated with Seroquel IR and who are additionally intended to start with an integrated care program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient department from clinics or private practices
Key inclusion criteria (4 listed)
- Outpatients suffering from schizophrenia, schizoaffective disorder, schizophreni-form disorder, delusional disorder or psychotic disorder not otherwise specified
- Age 18 - 65 years
- Current stable treatment with Seroquel according to SmPC since at least 2 months
- Given consent to take part in an integrated care program prior to study startWritten informed consent to take part in this NIS
Key exclusion criteria (2 listed)
- Presence of any contraindication as described in the SmPC
- Cancellation of participation in the integrated care program
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
Subjective Well-Being measured via SWN patient questionnaire
Time frame: 6 month period of observation,4 assessments
3 secondary outcomes
Quality of Life and patient's satisfaction measured by Q-LES-Q-18 and CSQ-8
Time frame: 6 month period of observation, 1 assessment at end of NIS
Symptomatic and functional outcome measured by CGI-S, PANSS-8, GAF, EQ-5D and VOI
Time frame: 6 month period of observation, 4 assesments
Compliance and health economic aspects measured by MARS, days of hospitalization, productivity loss
Time frame: 6 month period of observation, 4 assesments
Results and safety
The study was stopped early (reason given: Difficulty finding eligible sites/patients:current situation in health policy cause negative effects on existing/planned contracts for integrated care programs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
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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.
Sandra Liedtke, MD study director
AstraZeneca
Martin Lambert, PD, MD principal investigator
University of Hamberg
14 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 and Schizoaffective Disorder, run by AstraZeneca at 14 sites in Germany.
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 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: stopped early, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. 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 was stopped early (reason given: Difficulty finding eligible sites/patients:current situation in health policy cause negative effects on existing/planned contracts for integrated care programs). 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?
Subjective Well-Being measured via SWN patient questionnaire (time frame: 6 month period of observation,4 assessments). 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 10 Dec 2010.