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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00749970
First received: September 9, 2008
Last updated: December 8, 2010
Last verified: December 2010
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014