Longitudinal Long-term Study (10 Years) of the Sample of First Episode of Non-affective Psychosis: PAFIP

NCT02200588 | Unknown

• 1 other identifier: 10PAFIP
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  At 10 years

Secondary Outcomes (3)

• Relapse rate

  At 10 years

• Change in psychopathology

  At 10 years

• Hospital admission

  At 10 years

Study Arms (2)

Patients

Patients followed in the First Episode Psychosis Clinical Program (PAFIP) with psychotic disorder

Controls

Healthy subjects without psychotic disorder

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander - Cantabria).

You may qualify if:

• 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.

You may not qualify if:

• Meeting DSM-IV criteria for drug dependence.
• Meeting DSM-IV criteria for mental retardation.
• Having a history of neurological disease or head injury.

Sponsors & Collaborators

• Fundación Marques de Valdecilla: lead
• Centro de Investigación Biomédica en Red de Salud Mental: collaborator
• Instituto de Investigación Marqués de Valdecilla: collaborator

Study Sites (1)

University Hospital Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Related Publications (1)

• 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.

  PMID: 34004383 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma and serum.

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Benedicto Crespo-Facorro, Professor

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)