Clinical trial NCT01376492: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Sleep disturbances
Quality of sleep
Functioning level
Antipsychotic therapy.
Lead sponsor: Janssen-Cilag, S.A.
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 709
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag, S.A.
name: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial
role: STUDY_DIRECTOR
References: