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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

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
 Other: Functioning assessment
Other: Quality of sleep assessment
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen-Cilag, S.A.:

Enrollment: 709
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
Functioning assessment The functioning will be assessed with 2 scales (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)
 Other: Functioning assessment
The functioning will be assessed with 2 scales, (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)
002
Quality of sleep assessment The quality of sleep will be assessed with 2 scales (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)
 Other: Quality of sleep assessment
The quality of sleep will be assessed with 2 scales, (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376492

Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
  More Information

No publications provided

Responsible Party: Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier: NCT01376492     History of Changes
Other Study ID Numbers: CR017518, R076477SCH4053
Study First Received: June 16, 2011
Last Updated: March 7, 2013
Health Authority: Spain: Spanish Drug Agency

Keywords provided by Janssen-Cilag, S.A.:
Schizophrenia
Sleep disturbances
Quality of sleep
Functioning level
Antipsychotic therapy.

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013