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

NCT01376492 | Completed

• 2 other identifiers: CR017518R076477SCH4053
• Study Type: observational
• Target: 709
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Sleep disturbances; Quality of sleep; Functioning level; Antipsychotic therapy.

Study Arms (2)

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

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

Interventions

Functioning assessment OTHER

The functioning will be assessed with 2 scales, (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)

001

Quality of sleep assessment OTHER

The quality of sleep will be assessed with 2 scales, (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)

002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• (or guardian/ legal representative) consenting to participate in the study by signing the written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

MeSH Terms

Conditions

Schizophrenia; Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

  Janssen-Cilag, S.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 8, 2013

Record last verified: 2013-03