SchizophreniaPRE-COGNCT00358852
Scale Validation Study for Prediction of Relapse and Short Term Rehospitalization in Patients With Schizophrenia
An observational study of Schizophrenia, run by Janssen-Cilag, S.A..
Trial summary
The purpose of this study is to establish and validate a scale/model that can be used to evaluate the duration of time and factors between short term hospital treatment and subsequent relapse periods in patients with schizoaffective/schizophreniform disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 2,339 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Sep 2008
- 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 with schizophrenia, schizoaffective / schizophreniform more than 2 years of evolution and who are admitted to inpatient psychiatric units for short stay acute care setting.
Who may be able to join
- Patients with Schizophrenia or Schizoaffective disorder of more than 2 years evolution and who find themselves admitted in a Short-Term Psychiatric Hospitalization Unit or Acute Unit
Who cannot join
- Other patients with a psychiatric pathology different to schizophrenia, schizoaffective/schizophreniform disorders
- Patients with schizophrenia or schizoaffective/schizophreniform disorders of 2 years, or less evolution
- Pregnant, lactating, or planning to become pregnant within the next 12 months
About this study
Official title: Scale Validation of Prediction of Relapse and Rehospitalization Short Term in Patients With Schizophrenia
The purpose of this study is to establish and validate a scale/model that can be used to evaluate the duration of time and factors between short term hospital treatment and subsequent relapse periods in patients with schizoaffective/schizophreniform disorders.
Read the detailed description
This is an epidemiological (study of the distribution and determinants of health-related states or events in defined population), multicenter (study conducted at multiple sites), observational (study in which patients are observed), cross-sectional (observation of all patients at one specific point in time), prospective (in which the patients are first identified and then followed forward as time passes) study. The sources of information in the study are units medical short stay psychiatric hospitalization or the acute care of the whole country, and clinical data of the patient at discharge. No intervention will be provided in this study. The general data (age range, gender, highest level of educational attainment, level of family support, substance abuse, events stressors, type of schizophrenia according to DSM-IV criteria [Diagnostic and Statistical Manual fourth], etc) of approximately 2000 schizophrenia and schizoaffective disorder / schizophreniform patients will be collected in this study. No special tests will be done during the study. The study will collect patients' data in electronic data collection workbook and model validation will be used at 6 and 12 months to confirm no relapse / hospitalization. The study observation period corresponds to the 3 years preceding the current relapse and current income (current hospitalization period) and 12 months after admission.
- Conditions
- Schizophrenia
- Being tested
- No intervention
- Keywords
- Schizophrenia, Mental disorder, Schizoaffective disorder, Schizophreniform disorder, Epidemiological study, Scale validation, Relapse, Short Term Hospitalization, PRE-COG, RISSCH4075
- Medical subject headings
- Schizophrenia, Mental Disorders, Psychotic Disorders, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study. The data will be collected of patients suffering from schizophrenia and schizoaffective disorder / schizophreniform.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Schizophrenia | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to short-term relapse
Time to early relapse of patients discharged from a short-stay psychiatric hospitalisation unit.
Measured: Up to 12 months
Number of readmission of patients
Readmission in short-stay psychiatric hospital units when the schizophrenia or schizoaffective or schizophreniform disorder relapse.
Measured: Up to 12 months
Clinical Global Impression - Severity (CGI-S) Score
The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.
Measured: Up to 3 years
Secondary outcomes (7)
Duration of disease
Measured: Within 3 years before the study start
Drug abuse
Measured: Within 3 years before the study start
Psychiatric diagnosis
Patients diagnosed with Schizophrenia or Schizoaffective/schizophreniform disorder.
Measured: Within 3 years before the study start
Previous stress or event
Measured: Within 3 years before the study start
Hospitalizations in the previous 3 years
Measured: Within 3 years before the study start
Adherence to the psychiatric treatment
Measured: Within 3 years before the study start
Previous pharmacological treatment
Measured: Within 3 years before the study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionSep 2008
- Study completionSep 2008
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 2,339 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., Spain Clinical Trial, Study director, Janssen-Cilag, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358852
- Sponsor's protocol ID
- CR011989
- Other IDs
- RISSCH4075
- Acronym
- PRE-COG
- Status last verified
- Mar 2014
- First submitted
- 28 Jul 2006
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scale Validation of Prediction of Relapse and Rehospitalization Short Term in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00358852
- Acronym / sponsor ID
- PRE-COG / CR011989
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Mental disorder, Schizoaffective disorder, Schizophreniform disorder, Epidemiological study, Scale validation, Relapse, Short Term Hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,339 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 1 Aug 2006 (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 and validate a scale/model that can be used to evaluate the duration of time and factors between short term hospital treatment and subsequent relapse periods in patients with schizoaffective/schizophreniform disorders.
Detailed description
This is an epidemiological (study of the distribution and determinants of health-related states or events in defined population), multicenter (study conducted at multiple sites), observational (study in which patients are observed), cross-sectional (observation of all patients at one specific point in time), prospective (in which the patients are first identified and then followed forward as time passes) study. The sources of information in the study are units medical short stay psychiatric hospitalization or the acute care of the whole country, and clinical data of the patient at discharge. No intervention will be provided in this study. The general data (age range, gender, highest level of educational attainment, level of family support, substance abuse, events stressors, type of schizophrenia according to DSM-IV criteria [Diagnostic and Statistical Manual fourth], etc) of approximately 2000 schizophrenia and schizoaffective disorder / schizophreniform patients will be collected in this study. No special tests will be done during the study. The study will collect patients' data in electronic data collection workbook and model validation will be used at 6 and 12 months to confirm no relapse / hospitalization. The study observation period corresponds to the 3 years preceding the current relapse and current income (current hospitalization period) and 12 months after admission.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Schizophrenia | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with schizophrenia, schizoaffective / schizophreniform more than 2 years of evolution and who are admitted to inpatient psychiatric units for short stay acute care setting.
Key inclusion criteria (1 listed)
- Patients with Schizophrenia or Schizoaffective disorder of more than 2 years evolution and who find themselves admitted in a Short-Term Psychiatric Hospitalization Unit or Acute Unit
Key exclusion criteria (3 listed)
- Other patients with a psychiatric pathology different to schizophrenia, schizoaffective/schizophreniform disorders
- Patients with schizophrenia or schizoaffective/schizophreniform disorders of 2 years, or less evolution
- Pregnant, lactating, or planning to become pregnant within the next 12 months
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 |
|---|---|---|
| No interventionThis is an observational study. The data will be collected of patients suffering from schizophrenia and schizoaffective disorder / schizophreniform. | Other | Patients with Schizophrenia |
Primary outcome
Time to short-term relapse
Time frame: Up to 12 months
Time to early relapse of patients discharged from a short-stay psychiatric hospitalisation unit.
Number of readmission of patients
Time frame: Up to 12 months
Readmission in short-stay psychiatric hospital units when the schizophrenia or schizoaffective or schizophreniform disorder relapse.
Clinical Global Impression - Severity (CGI-S) Score
Time frame: Up to 3 years
The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.
7 secondary outcomes
Duration of disease
Time frame: Within 3 years before the study start
Drug abuse
Time frame: Within 3 years before the study start
Psychiatric diagnosis
Time frame: Within 3 years before the study start
Previous stress or event
Time frame: Within 3 years before the study start
Hospitalizations in the previous 3 years
Time frame: Within 3 years before the study start
Adherence to the psychiatric treatment
Time frame: Within 3 years before the study start
Previous pharmacological treatment
Time frame: Within 3 years before the study start
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 19 Mar 2014.
- Scale Validation of Prediction of Relapse and Rehospitalization Short Term in Patients with SchizophreniaLink provided by the sponsor.
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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., Spain 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 1 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 19 Mar 2014. 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.
What does the primary outcome measure?
Time to short-term relapse (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 19 Mar 2014; AzTrials last refreshed its copy on 2 Nov 2026.