<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02200588</url>
  </required_header>
  <id_info>
    <org_study_id>10PAFIP</org_study_id>
    <nct_id>NCT02200588</nct_id>
  </id_info>
  <brief_title>Longitudinal Long-term Study (10 Years) of the Sample of First Episode of Non-affective Psychosis: PAFIP</brief_title>
  <acronym>10PAFIP</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Marques de Valdecilla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro de Investigación Biomédica en Red de Salud Mental</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto de Investigación Marqués de Valdecilla</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación Marques de Valdecilla</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Schizophrenia is a chronic brain disease that is still understood as a condition that limits&#xD;
      the development of a normal life for the patient who suffers it and their families. The idea&#xD;
      that only one third of patients have a good outcome is still in force, despite the lack of&#xD;
      clinical and epidemiological longitudinal studies that have addressed this issue rigorously.&#xD;
      Most studies that have established the poor prognosis of the disease have followed a&#xD;
      cross-sectional design and are based on samples of patients undergoing treatment in&#xD;
      healthcare devices and therefore represents an important bias. Based on clinical, cognitive,&#xD;
      functional outcome and biomarkers studies (brain imaging) to medium term (3 years) we can&#xD;
      establish that the particular idea of poor prognosis should be reconsidered. The development&#xD;
      of longitudinal studies of first-episode patients in representative samples of a population&#xD;
      and long-term it is of high value to shed light on the clinical course of the disease. The&#xD;
      belief that there are factors determining the disease progression beyond the initial three&#xD;
      years brings us to publish this study.&#xD;
&#xD;
      Given this background, our project's main objective is to know the evolution at 10 years of&#xD;
      patients followed in the First Episode Psychosis Clinical Program (PAFIP). Our hypothesis is&#xD;
      that a higher percentage of expected patients have a favorable outcome of the disease.&#xD;
      Factors such as enhancing treatment completion, abstinence from drug use, return to work, the&#xD;
      reduction of expressed emotion in families during the early years of the disease (at least 3&#xD;
      years of intensive intervention PAFIP) will have a positive impact on the evolution of&#xD;
      patients on long-term (10 years). Our hypothesis defends the existence of certain factors as&#xD;
      independent risk factors for poor clinical and functional outcome of patients who should be&#xD;
      known for establishing intervention strategies that attempt to mitigate their impact on the&#xD;
      quality of life of patients and their families.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>2 Days</target_duration>
  <primary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>At 10 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relapse rate</measure>
    <time_frame>At 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psychopathology</measure>
    <time_frame>At 10 years</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital admission</measure>
    <time_frame>At 10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">277</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients followed in the First Episode Psychosis Clinical Program (PAFIP) with psychotic disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Healthy subjects without psychotic disorder</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, plasma and serum.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the&#xD;
        University Hospital Marqués de Valdecilla (Santander - Cantabria).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients followed in the First Episode Psychosis Clinical Program (PAFIP) from&#xD;
             February 2001 to December 2007.&#xD;
&#xD;
          -  Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)&#xD;
             criteria of brief psychotic disorder, schizophreniform disorder, schizophrenia or&#xD;
             schizoaffective disorder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meeting DSM-IV criteria for drug dependence.&#xD;
&#xD;
          -  Meeting DSM-IV criteria for mental retardation.&#xD;
&#xD;
          -  Having a history of neurological disease or head injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benedicto Crespo-Facorro, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>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</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>December 14, 2020</last_update_submitted>
  <last_update_submitted_qc>December 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación Marques de Valdecilla</investigator_affiliation>
    <investigator_full_name>Benedicto Crespo-Facorro</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>psychosis</keyword>
  <keyword>schizophrenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02200588
org study id: 10PAFIP
nct id: NCT02200588
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Functional outcome
time frame: At 10 years
description: 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.
measure: Relapse rate
time frame: At 10 years
measure: Change in psychopathology
time frame: At 10 years
description: 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).
measure: Hospital admission
time frame: At 10 years
arm group label: Patients
description: Patients followed in the First Episode Psychosis Clinical Program (PAFIP) with psychotic disorder
arm group label: Controls
description: Healthy subjects without psychotic disorder
Whole blood, plasma and serum.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Benedicto Crespo-Facorro, Professor
role: Principal Investigator
affiliation: 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
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundación Marques de Valdecilla
investigator full name: Benedicto Crespo-Facorro
investigator title: Associate Professor of Psychiatry
mesh term: Schizophrenia
mesh term: Psychotic Disorders
mesh term: Mental Disorders
sharing ipd: No