SchizophreniaSWN-KNCT00749970
Validity of the Spanish Version of Subjective Well-being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia
An observational study of Schizophrenia and Schizoaffective Disorder, run by AstraZeneca at 14 sites in Spain.
Trial summary
Observational, short-term prospective, multicenter study to assess psychometric properties of the Spanish version of SWN-K scale in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- How many people
- 100 participants
- Where
- 14 sitesSpain
- Study dates
- Jul 2008to Jan 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 with a diagnosis of schizophrenia, schizoaffective disorder, or shizophreniform disorder
Who may be able to join
- Patients with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder (DSM-IV TR criteria)
- Stabilized out-patients
- Under treatment with an oral antipsychotic drug
Who cannot join
- Administration of a depot antipsychotic drug
- Participation in another clinical trial within 4 weeks prior to enrolment into this study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Research Site
Alicante
Research site
Barcelona
Research site
Burgos
Research Site
Córdoba
Research Site
Granada
Research site
Madrid
Research Site
Mallorca
Research Site
Salamanca
Research Site
Seville
Research site
Tarragona
Research Site
Valencia
Research Site
Valladolid
Research Site
Vitoria-Gasteiz
Research Site
Zaragoza
About this study
Observational, short-term prospective, multicenter study to assess psychometric properties of the Spanish version of SWN-K scale in patients with schizophrenia.
- Keywords
- schizophrenia, subjective well-being, psychometric validation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
SWN-K
Measured: 7 days
PANSS
Measured: 7 days
Secondary outcomes (1)
CGI-I
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2009
- Study completionJan 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749970
- Sponsor's protocol ID
- NIS-NES-DUM-2008/1
- Acronym
- SWN-K
- Status last verified
- Dec 2010
- First submitted
- 9 Sep 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
- Validity of the Spanish Version of Subjective Well-being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00749970
- Acronym / sponsor ID
- SWN-K / NIS-NES-DUM-2008/1
- Keywords
- schizophrenia, subjective well-being, psychometric validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Sep 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.
Observational, short-term prospective, multicenter study to assess psychometric properties of the Spanish version of SWN-K scale in patients with schizophrenia.
Study design
- Time perspective
- Prospective
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 with a diagnosis of schizophrenia, schizoaffective disorder, or shizophreniform disorder
Key inclusion criteria (3 listed)
- Patients with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder (DSM-IV TR criteria)
- Stabilized out-patients
- Under treatment with an oral antipsychotic drug
Key exclusion criteria (2 listed)
- Administration of a depot antipsychotic drug
- Participation in another clinical trial within 4 weeks prior to enrolment into this 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
SWN-K
Time frame: 7 days
PANSS
Time frame: 7 days
1 secondary outcome
CGI-I
Time frame: 7 days
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 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 3 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 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 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?
SWN-K (time frame: 7 days). 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 10 Dec 2010.