FYS Study: Epidemiological, Multicentre, Cross-sectional Study in a Clinical Practice Environment, About the Relationship Between Functioning Status and the Quality of Sleep Perceived by Schizophrenic Outpatients in Spain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT01376492
First received: June 16, 2011
Last updated: March 7, 2013
Last verified: March 2013

June 16, 2011
March 7, 2013
November 2010
July 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01376492 on ClinicalTrials.gov Archive Site
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FYS Study: Epidemiological, Multicentre, Cross-sectional Study in a Clinical Practice Environment, About the Relationship Between Functioning Status and the Quality of Sleep Perceived by Schizophrenic Outpatients in Spain
Epidemiological, Multicentre, Cross-sectional Study in a Clinical Practice Environment, About the Relationship Between Functioning Status and the Quality of Sleep Perceived by Schizophrenic Outpatients in Spain

The purpose of this study is to establish the relationship between performance of patients with schizophrenia and relationship with perceived quality of sleep. The secondary objectives are: to establish the prevalence of schizophrenic patients reporting sleep disturbances; to assess the potential epidemiological risk factors associated with the perceived impairment of quality of sleep; to establish the relationship between the clinical condition and the quality of sleep perceived; to assess the performance level of patients.

This is a multicenter, cross-sectional, epidemiological study in the daily clinical practice on the relationship between personal and social functionality and quality of sleep perceived in outpatients with schizophrenia. It is proposed to perform a simple screening for detecting schizophrenic patients reporting sleep disturbances. These patients will be assessed in a single visit and will be administered a number of quality of life and functional assessment scales. N/A

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample

Patients diagnosed with schizophrenia seen in outpatient mental health care facilities distributed all over the country, with and without sleep disturbances at the time of the visit.

Schizophrenia
  • Other: Functioning assessment
    The functioning will be assessed with 2 scales, (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)
  • Other: Quality of sleep assessment
    The quality of sleep will be assessed with 2 scales, (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)
  • 001
    Functioning assessment The functioning will be assessed with 2 scales (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)
    Intervention: Other: Functioning assessment
  • 002
    Quality of sleep assessment The quality of sleep will be assessed with 2 scales (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)
    Intervention: Other: Quality of sleep assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
709
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient diagnosed of schizophrenia
  • reporting sleep disturbances at the time of the visit or patient not reporting sleep disturbances at the time of the visit
  • who are on stable antipsychotic therapy for at least 6 months prior to inclusion in the study
  • (or guardian/ legal representative) consenting to participate in the study by signing the written informed consent.

Exclusion Criteria:

  • Patient who, in the investigator's opinion, fails to keep an adequate cognitive ability to continue the study and complete the questionnaires
  • who has any type of severe sleep disturbances related to disorders of the patient other than schizophrenia (e.g., nightmares, nocturnal fears, restless leg syndrome)
  • or included in another clinical study or trial that can interfere with the normal control of the disease.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01376492
CR017518, R076477SCH4053
Not Provided
Janssen-Cilag, S.A.
Janssen-Cilag, S.A.
Not Provided
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
Janssen-Cilag, S.A.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP