Validity of the Spanish Version of Subjective Well-Being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia

This study has been completed.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00749970

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

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Validity of the Spanish Version of Subjective Well-Being Under Neuroleptics Scale (SWN-K) in Patients With Schizophrenia

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	June 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (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
Mallorca, Spain
Research Site
Salamanca, Spain
Research Site
Zaragoza, Spain
Research Site
Sevilla, Spain
Research Site
Valladolid, Spain
Research Site
Valencia, Spain
Research Site
Vitoria, Spain
Research site
Tarragona, Spain
Research Site
Granada, Spain
Research Site
Alicante, Spain
Research site
Burgos, Spain
Research site
Madrid, Spain
Research site
Barcelona, Spain
Research Site
Cordoba, Spain

Sponsors and Collaborators

AstraZeneca

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Teresa Diez )
Study ID Numbers:	NIS-NES-DUM-2008/1
Study First Received:	September 9, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00749970
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by AstraZeneca:

schizophrenia
subjective well-being
psychometric validation

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009