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

Schizophrenia Clinical Trial

— 10PAFIP  

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02200588
• Other study ID #: 10PAFIP
• Status: Enrolling by invitation
• Start date: September 2014
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: Fundación Marques de Valdecilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 277
• Est. completion date: December 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Meeting DSM-IV criteria for drug dependence.

• Meeting DSM-IV criteria for mental retardation.

• Having a history of neurological disease or head injury.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Locations

Country	Name	City	State
Spain	University Hospital Marques de Valdecilla	Santander	Cantabria

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Marques de Valdecilla	Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relapse rate		At 10 years
Secondary	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).	At 10 years
Secondary	Hospital admission		At 10 years