SchizophreniaNCT01376492
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
An observational study of Schizophrenia, run by Janssen-Cilag, S.A..
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Functioning assessment and Quality of sleep assessment
- How many people
- 709 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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
- Conditions
- Schizophrenia
- Being tested
- Functioning assessment, Quality of sleep assessment
- Keywords
- Schizophrenia, Sleep disturbances, Quality of sleep, Functioning level, Antipsychotic therapy.
- Medical subject headings
- Schizophrenia, Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functioning assessmentOther
The functioning will be assessed with 2 scales, (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)
Quality of sleep assessmentOther
The quality of sleep will be assessed with 2 scales, (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)
| Study group | Role | What they receive |
|---|---|---|
| 001 | Functioning assessment The functioning will be assessed with 2 scales (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale) Receives: 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) Receives: Other: Quality of sleep assessment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 709 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial, Study director, Janssen-Cilag, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376492
- Sponsor's protocol ID
- CR017518
- Other IDs
- R076477SCH4053
- Status last verified
- Mar 2013
- First submitted
- 16 Jun 2011
- Last updated
- 8 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01376492
- Acronym / sponsor ID
- CR017518
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Sleep disturbances, Quality of sleep, Functioning level, Antipsychotic therapy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 709 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: Functioning assessmentFunctioning assessment The functioning will be assessed with 2 scales (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale) |
| 002 | – | Other: Quality of sleep assessmentQuality of sleep assessment The quality of sleep will be assessed with 2 scales (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functioning assessmentThe functioning will be assessed with 2 scales, (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale) | Other | 001 |
| Quality of sleep assessmentThe quality of sleep will be assessed with 2 scales, (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale) | Other | 002 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial study director
Janssen-Cilag, S.A.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen-Cilag, S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.