Validity of the Spanish Version of Subjective Well-being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00749970
First received: September 9, 2008
Last updated: December 8, 2010
Last verified: December 2010
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Purpose
Observational, short-term prospective, multicenter study to assess psychometric properties of the Spanish version of SWN-K scale in patients with schizophrenia.
| Condition |
|---|
|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Validity of the Spanish Version of Subjective Well-being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- SWN-K [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- PANSS [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CGI-I [ Time Frame: 7 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patient aged 18-year old or older with a diagnosis of schizophrenia, schizoaffective disorder, or shizophreniform disorder
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Administration of a depot antipsychotic drug
- Participation in another clinical trial within 4 weeks prior to enrolment into this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749970
Locations
| Spain | |
| Research Site | |
| Alicante, Spain | |
| Research site | |
| Barcelona, Spain | |
| Research site | |
| Burgos, Spain | |
| Research Site | |
| Cordoba, Spain | |
| Research Site | |
| Granada, Spain | |
| Research site | |
| Madrid, Spain | |
| Research Site | |
| Mallorca, Spain | |
| Research Site | |
| Salamanca, Spain | |
| Research Site | |
| Sevilla, Spain | |
| Research site | |
| Tarragona, Spain | |
| Research Site | |
| Valencia, Spain | |
| Research Site | |
| Valladolid, Spain | |
| Research Site | |
| Vitoria, Spain | |
| Research Site | |
| Zaragoza, Spain | |
Sponsors and Collaborators
AstraZeneca
More Information
No publications provided
| Responsible Party: | Teresa Diez, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00749970 History of Changes |
| Other Study ID Numbers: | NIS-NES-DUM-2008/1 |
| Study First Received: | September 9, 2008 |
| Last Updated: | December 8, 2010 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by AstraZeneca:
|
schizophrenia subjective well-being psychometric validation |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013