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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376492
• Other study ID #: CR017518
• Secondary ID: R076477SCH4053
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2011
• Last updated: March 7, 2013
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2013
• Source: Janssen-Cilag, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Drug Agency
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 709
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Functioning assessment
The functioning will be assessed with 2 scales, (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)
• Quality of sleep assessment
The quality of sleep will be assessed with 2 scales, (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag, S.A.