Schizophrenia10PAFIPNCT02200588
Longitudinal Long-term Study (10 Years) of the Sample of First Episode of Non-affective Psychosis: PAFIP
An observational study of Schizophrenia, run by Fundación Marques de Valdecilla at 1 site in Spain.
Trial summary
Schizophrenia is a chronic brain disease that is still understood as a condition that limits the development of a normal life for the patient who suffers it and their families. The idea that only one third of patients have a good outcome is still in force, despite the lack of clinical and epidemiological longitudinal… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 277 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Dec 2020
- How long will I take part?
- 2 Days
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander - Cantabria).
Who may be able to join
- Patients followed in the First Episode Psychosis Clinical Program (PAFIP) from February 2001 to December 2007.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of brief psychotic disorder, schizophreniform disorder, schizophrenia or schizoaffective disorder.
Who cannot join
- Meeting DSM-IV criteria for drug dependence.
- Meeting DSM-IV criteria for mental retardation.
- Having a history of neurological disease or head injury.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Hospital Marques de Valdecilla
Santander, Cantabria, 39008
About this study
Official title: A Longitudinal Long-term Study (10 Years) of the Sample of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program (PAFIP)
Schizophrenia is a chronic brain disease that is still understood as a condition that limits the development of a normal life for the patient who suffers it and their families. The idea that only one third of patients have a good outcome is still in force, despite the lack of clinical and epidemiological longitudinal studies that have addressed this issue rigorously. Most studies that have established the poor prognosis of the disease have followed a cross-sectional design and are based on samples of patients undergoing treatment in healthcare devices and therefore represents an important bias. Based on clinical, cognitive, functional outcome and biomarkers studies (brain imaging) to medium term (3 years) we can establish that the particular idea of poor prognosis should be reconsidered. The development of longitudinal studies of first-episode patients in representative samples of a population and long-term it is of high value to shed light on the clinical course of the disease. The belief that there are factors determining the disease progression beyond the initial three years brings us to publish this study.
Given this background, our project's main objective is to know the evolution at 10 years of patients followed in the First Episode Psychosis Clinical Program (PAFIP). Our hypothesis is that a higher percentage of expected patients have a favorable outcome of the disease. Factors such as enhancing treatment completion, abstinence from drug use, return to work, the reduction of expressed emotion in families during the early years of the disease (at least 3 years of intensive intervention PAFIP) will have a positive impact on the evolution of patients on long-term (10 years). Our hypothesis defends the existence of certain factors as independent risk factors for poor clinical and functional outcome of patients who should be known for establishing intervention strategies that attempt to mitigate their impact on the quality of life of patients and their families.
- Conditions
- Schizophrenia
- Keywords
- psychosis, schizophrenia
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients followed in the First Episode Psychosis Clinical Program (PAFIP) with psychotic disorder | |
| Controls | Healthy subjects without psychotic disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Measured by Disability Assessment Scale (DAS), Global Assessment Functioning (GAF), Quality of Life Scale (QLS), Subjective Well-being under Neuroleptic Scale (SWN-K) and Strauss-Carpenter Scale.
Measured: At 10 years
Secondary outcomes (3)
Relapse rate
Measured: At 10 years
Change in psychopathology
Measured by the Scale for the Assessment of Negative and Positive Symptoms (SANS and SAPS), Brief Negative Symptom Scale (BNSS), Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI-S), Calgary Depression Scale (CDS) and Young Mania Rating Scale (YMRS).
Measured: At 10 years
Hospital admission
Measured: At 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2017
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 277 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Fundación Marques de Valdecilla
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla
- Responsible party
- Principal investigator, Benedicto Crespo-Facorro, Fundación Marques de Valdecilla
- Investigators
- Benedicto Crespo-Facorro, Professor, Principal investigator, University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200588
- Sponsor's protocol ID
- 10PAFIP
- Acronym
- 10PAFIP
- Status last verified
- Dec 2020
- First submitted
- 23 Jul 2014
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mayoral-van Son J, Juncal-Ruiz M, Ortiz-Garcia de la Foz V, Vazquez-Bourgon J, Setien-Suero E, Tordesillas-Gutierrez D, Gomez-Revuelta M, Ayesa-Arriola R, Crespo-Facorro B; PAFIP Research Group. Long-term clinical and functional outcome after antipsychotic discontinuation in early phases of non-affective psychosis: Results from the PAFIP-10 cohort. Schizophr Res. 2021 Jun;232:28-30. doi: 10.1016/j.schres.2021.04.011. Epub 2021 May 16. No abstract available.
PubMed 34004383
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Long-term Study (10 Years) of the Sample of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program (PAFIP)
- ClinicalTrials.gov ID
- NCT02200588
- Acronym / sponsor ID
- 10PAFIP / 10PAFIP
- Conditions
- Schizophrenia
- Keywords
- psychosis, schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 277 participants (estimated)
- Lead sponsor
- Fundación Marques de ValdecillaUniversity, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Jul 2014 (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.
Schizophrenia is a chronic brain disease that is still understood as a condition that limits the development of a normal life for the patient who suffers it and their families. The idea that only one third of patients have a good outcome is still in force, despite the lack of clinical and epidemiological longitudinal studies that have addressed this issue rigorously. Most studies that have established the poor prognosis of the disease have followed a cross-sectional design and are based on samples of patients undergoing treatment in healthcare devices and therefore represents an important bias. Based on clinical, cognitive, functional outcome and biomarkers studies (brain imaging) to medium term (3 years) we can establish that the particular idea of poor prognosis should be reconsidered. The development of longitudinal studies of first-episode patients in representative samples of a population and long-term it is of high value to shed light on the clinical course of the disease. The belief that there are factors determining the disease progression beyond the initial three years brings us to publish this study.
Given this background, our project's main objective is to know the evolution at 10 years of patients followed in the First Episode Psychosis Clinical Program (PAFIP). Our hypothesis is that a higher percentage of expected patients have a favorable outcome of the disease. Factors such as enhancing treatment completion, abstinence from drug use, return to work, the reduction of expressed emotion in families during the early years of the disease (at least 3 years of intensive intervention PAFIP) will have a positive impact on the evolution of patients on long-term (10 years). Our hypothesis defends the existence of certain factors as independent risk factors for poor clinical and functional outcome of patients who should be known for establishing intervention strategies that attempt to mitigate their impact on the quality of life of patients and their families.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients followed in the First Episode Psychosis Clinical Program (PAFIP) with psychotic disorder |
| Controls | – | –Healthy subjects without psychotic disorder |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander - Cantabria).
Key inclusion criteria (2 listed)
- Patients followed in the First Episode Psychosis Clinical Program (PAFIP) from February 2001 to December 2007.
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of brief psychotic disorder, schizophreniform disorder, schizophrenia or schizoaffective disorder.
Key exclusion criteria (3 listed)
- Meeting DSM-IV criteria for drug dependence.
- Meeting DSM-IV criteria for mental retardation.
- Having a history of neurological disease or head injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional outcome
Time frame: At 10 years
Measured by Disability Assessment Scale (DAS), Global Assessment Functioning (GAF), Quality of Life Scale (QLS), Subjective Well-being under Neuroleptic Scale (SWN-K) and Strauss-Carpenter Scale.
3 secondary outcomes
Relapse rate
Time frame: At 10 years
Change in psychopathology
Time frame: At 10 years
Hospital admission
Time frame: At 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Derived from this study: PubMed 34004383Mayoral-van Son J, Juncal-Ruiz M, Ortiz-Garcia de la Foz V, Vazquez-Bourgon J, Setien-Suero E, Tordesillas-Gutierrez D, Gomez-Revuelta M, Ayesa-Arriola R, Crespo-Facorro B; PAFIP Research Group. Long-term clinical and functional outcome after antipsychotic discontinuation in early phases of non-affective psychosis: Results from the PAFIP-10 cohort. Schizophr Res. 2021 Jun;232:28-30. doi: 10.1016/j.schres.2021.04.011. Epub 2021 May 16. No abstract available.
- Individual participant dataSharing planned: No
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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.
Benedicto Crespo-Facorro, Professor principal investigator
University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Fundación Marques de Valdecilla at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Functional outcome (time frame: At 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02200588, which also lists 1 linked publication.
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 16 Dec 2020.