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Clinical Trials/NCT01376492
NCT01376492
Completed
N/A

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

Janssen-Cilag, S.A.0 sites709 target enrollmentNovember 2010
ConditionsSchizophrenia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Janssen-Cilag, S.A.
Enrollment
709
Status
Completed
Last Updated
13 years ago

Overview

Brief 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.

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

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
July 2011
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Janssen-Cilag, S.A.
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Not specified

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